Topical NVN1000 for the Treatment of External Genital and Perianal Warts

A Phase 2, Multi-center, Double-blind, Randomized, Vehicle-controlled, Ascending Dose Study Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects With External Genital Warts and Perianal Warts

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02462187

Enrollment

108

Registered

2015-06-03

Start date

2015-06-12

Completion date

2016-10-17

Last updated

2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genital Warts, Perianal Warts

Keywords

genital warts, perianal warts

Brief summary

A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Ascending Dose Study Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects with External Genital Warts and Perianal Warts

Detailed description

This is a phase 2, multi-center, randomized, double-blind, vehicle-controlled, ascending dose study to assess safety, tolerability and efficacy of a topical nitric oxide releasing compound in subjects with external genital and perianal warts. Eligible subjects will be treated with a topical gel (active or vehicle) for up to 12 weeks.

Interventions

DRUGNVN1000 8% Gel

once and twice daily

DRUGNVN1000 16%

once daily

DRUGVehicle

placebo comparator

DRUGNVN1000 24%

once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* At least 2 but not more than 20 genital/perianal warts with a maximum total wart surface area no more than 1% body surface area * If a woman of child-bearing potential, have a negative pregnancy test and use effective contraception * If currently receiving wart treatment, be willing to stop all treatment for 28 days prior to randomization and during the study

Exclusion criteria

* Immunocompromised patients including those with HIV, receiving radiation, or drugs that suppress the immune system * Pregnant, planning to become pregnant, or nursing * History of cancer (including cervical cancer) within 5 years, with exception of non-melanoma skin cancer in non-genital skin * Recent history of other genital skin infections * Active HSV and frequent HSV recurrences unless receiving suppression therapy * Have hemoglobin \< 10 G/dl or methemoglobin \> 3% * Known allergy to any component of the gel including excipients * Previously participated in any study with NVN1000 or SB204

Design outcomes

Primary

Measure	Time frame	Description
Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12	12 weeks	Clearance of baseline external genital and perianal warts at or before Week 12 as determined by physical examination by the investigator.

Secondary

Measure	Time frame	Description
Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Baseline, Week 2, Week 4, Week 8, Week 12	Comparison of scores for erythema, edema, erosions/ulcers, itch between active and vehicle treated subjects using a 4 point grading scale; on the tolerability scale, 0 = none and 3 = severe, indicating an increase in severity the higher the number assigned.
Safety as Determined by Changes in Laboratory Assessments	Baseline, Week 2 and Week 12	Safety population--Comparison of changes in methemoglobin levels between active and vehicle treated subjects. Methemoglobin levels were measured using a RAD-57 pulse co-oximeter. Values are expressed as a percentage of hemoglobin.
Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12	12 weeks	The percentage of subjects with complete clearance of baseline and warts that emerge during treatment period as determined by physical examination by the investigator
Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12	12 weeks	Percentage of subjects with complete or partial clearance of baseline warts as determined by physical examination by the investigator

Countries

United States

Participant flow

Recruitment details

120 subjects were planned to be enrolled; 108 subjects were actually enrolled per the Sponsor's decision.

Participants by arm

Arm	Count
Cohort 1: NVN1000 8% Gel Twice Daily NVN1000 8% Gel applied topically twice daily	12
Cohort 2: NVN1000 8% Gel Once Daily NVN1000 8% Gel applied topically once daily	24
Cohort 3: NVN1000 16% Once Daily NVN1000 16% Gel applied topically once daily	14
Cohort 4: NVN1000 24% Once Daily NVN1000 24% applied topically once daily	30
Vehicle Gel Once Daily Vehicle: placebo comparator	23
Vehicle Gel Twice Daily Vehicle: placebo comparator	4
Total	107

Baseline characteristics

Characteristic	Cohort 1: NVN1000 8% Gel Twice Daily	Total	Vehicle Gel Twice Daily	Cohort 2: NVN1000 8% Gel Once Daily	Vehicle Gel Once Daily	Cohort 4: NVN1000 24% Once Daily	Cohort 3: NVN1000 16% Once Daily
Age, Continuous	36.8 years STANDARD_DEVIATION 7.13	33.4 years STANDARD_DEVIATION 7.12	31.5 years STANDARD_DEVIATION 9	33.3 years STANDARD_DEVIATION 6.68	32.2 years STANDARD_DEVIATION 7.41	33.6 years STANDARD_DEVIATION 6.77	32.5 years STANDARD_DEVIATION 7.86
Baseline Wart Count	9.3 number of warts STANDARD_DEVIATION 5.93	7.4 number of warts STANDARD_DEVIATION 5.19	7.8 number of warts STANDARD_DEVIATION 3.4	7.5 number of warts STANDARD_DEVIATION 5.05	7.7 number of warts STANDARD_DEVIATION 5.83	7.2 number of warts STANDARD_DEVIATION 5.58	5.1 number of warts STANDARD_DEVIATION 2.6
Current Tobacco Use No	7 Participants	72 Participants	1 Participants	19 Participants	15 Participants	18 Participants	12 Participants
Current Tobacco Use Yes	5 Participants	35 Participants	3 Participants	5 Participants	8 Participants	12 Participants	2 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	30 Participants	2 Participants	6 Participants	9 Participants	5 Participants	5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants	77 Participants	2 Participants	18 Participants	14 Participants	25 Participants	9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	3 Participants	29 Participants	0 Participants	8 Participants	5 Participants	10 Participants	3 Participants
Race (NIH/OMB) More than one race	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	9 Participants	76 Participants	4 Participants	16 Participants	17 Participants	19 Participants	11 Participants
Region of Enrollment United States	12 participants	107 participants	4 participants	24 participants	23 participants	30 participants	14 participants
Sex: Female, Male Female	6 Participants	31 Participants	2 Participants	8 Participants	6 Participants	7 Participants	2 Participants
Sex: Female, Male Male	6 Participants	76 Participants	2 Participants	16 Participants	17 Participants	23 Participants	12 Participants
Wart Location at Baseline EGW and PAW	1 Participants	18 Participants	0 Participants	5 Participants	7 Participants	4 Participants	1 Participants
Wart Location at Baseline External genital warts (EGW) only	9 Participants	76 Participants	3 Participants	17 Participants	15 Participants	19 Participants	13 Participants
Wart Location at Baseline Perianal warts (PAW) only	2 Participants	13 Participants	1 Participants	2 Participants	1 Participants	7 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	0 / 12	0 / 23	0 / 14	0 / 30	0 / 20	0 / 4
other Total, other adverse events	9 / 12	13 / 23	5 / 14	7 / 30	4 / 20	0 / 4
serious Total, serious adverse events	2 / 12	0 / 23	1 / 14	0 / 30	0 / 20	0 / 4

Outcome results

Primary

Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12

Clearance of baseline external genital and perianal warts at or before Week 12 as determined by physical examination by the investigator.

Time frame: 12 weeks

Population: ITT population. One subject in the NVN1000 8% Gel BID group was randomized but not dispensed treatment and thus was excluded from the ITT population..

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: NVN1000 8% Gel Twice Daily	Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12	2 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12	5 Participants
Cohort 3: NVN1000 16% Once Daily	Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12	2 Participants
Cohort 4: NVN1000 24% Once Daily	Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12	10 Participants
Vehicle Gel Once Daily	Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12	1 Participants
Vehicle Gel Twice Daily	Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12	2 Participants

Secondary

Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12

The percentage of subjects with complete clearance of baseline and warts that emerge during treatment period as determined by physical examination by the investigator

Time frame: 12 weeks

Population: Intent to treat (ITT)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: NVN1000 8% Gel Twice Daily	Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12	2 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12	5 Participants
Cohort 3: NVN1000 16% Once Daily	Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12	2 Participants
Cohort 4: NVN1000 24% Once Daily	Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12	9 Participants
Vehicle Gel Once Daily	Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12	1 Participants
Vehicle Gel Twice Daily	Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12	2 Participants

Secondary

Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12

Percentage of subjects with complete or partial clearance of baseline warts as determined by physical examination by the investigator

Time frame: 12 weeks

Population: Intent to treat (ITT)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: NVN1000 8% Gel Twice Daily	Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12	8 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12	19 Participants
Cohort 3: NVN1000 16% Once Daily	Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12	10 Participants
Cohort 4: NVN1000 24% Once Daily	Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12	17 Participants
Vehicle Gel Once Daily	Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12	11 Participants
Vehicle Gel Twice Daily	Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12	2 Participants

Secondary

Safety as Determined by Changes in Laboratory Assessments

Safety population--Comparison of changes in methemoglobin levels between active and vehicle treated subjects. Methemoglobin levels were measured using a RAD-57 pulse co-oximeter. Values are expressed as a percentage of hemoglobin.

Time frame: Baseline, Week 2 and Week 12

Population: Safety population

Arm	Measure	Group	Value (MEAN)
Cohort 1: NVN1000 8% Gel Twice Daily	Safety as Determined by Changes in Laboratory Assessments	Week 2	1.33 Percentage
Cohort 1: NVN1000 8% Gel Twice Daily	Safety as Determined by Changes in Laboratory Assessments	Week 12	1.55 Percentage
Cohort 1: NVN1000 8% Gel Twice Daily	Safety as Determined by Changes in Laboratory Assessments	Baseline	1.33 Percentage
Cohort 2: NVN1000 8% Gel Once Daily	Safety as Determined by Changes in Laboratory Assessments	Week 12	1.34 Percentage
Cohort 2: NVN1000 8% Gel Once Daily	Safety as Determined by Changes in Laboratory Assessments	Week 2	1.33 Percentage
Cohort 2: NVN1000 8% Gel Once Daily	Safety as Determined by Changes in Laboratory Assessments	Baseline	1.25 Percentage
Cohort 3: NVN1000 16% Once Daily	Safety as Determined by Changes in Laboratory Assessments	Baseline	1.38 Percentage
Cohort 3: NVN1000 16% Once Daily	Safety as Determined by Changes in Laboratory Assessments	Week 2	1.42 Percentage
Cohort 3: NVN1000 16% Once Daily	Safety as Determined by Changes in Laboratory Assessments	Week 12	1.26 Percentage
Cohort 4: NVN1000 24% Once Daily	Safety as Determined by Changes in Laboratory Assessments	Week 12	1.36 Percentage
Cohort 4: NVN1000 24% Once Daily	Safety as Determined by Changes in Laboratory Assessments	Week 2	1.33 Percentage
Cohort 4: NVN1000 24% Once Daily	Safety as Determined by Changes in Laboratory Assessments	Baseline	1.29 Percentage
Vehicle Gel Once Daily	Safety as Determined by Changes in Laboratory Assessments	Baseline	1.31 Percentage
Vehicle Gel Once Daily	Safety as Determined by Changes in Laboratory Assessments	Week 2	1.34 Percentage
Vehicle Gel Once Daily	Safety as Determined by Changes in Laboratory Assessments	Week 12	1.59 Percentage
Vehicle Gel Twice Daily	Safety as Determined by Changes in Laboratory Assessments	Baseline	1.53 Percentage
Vehicle Gel Twice Daily	Safety as Determined by Changes in Laboratory Assessments	Week 12	1.50 Percentage
Vehicle Gel Twice Daily	Safety as Determined by Changes in Laboratory Assessments	Week 2	1.48 Percentage

Secondary

Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch

Comparison of scores for erythema, edema, erosions/ulcers, itch between active and vehicle treated subjects using a 4 point grading scale; on the tolerability scale, 0 = none and 3 = severe, indicating an increase in severity the higher the number assigned.

Time frame: Baseline, Week 2, Week 4, Week 8, Week 12

Population: Safety population

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	1 (mild)	1 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	0 (none)	8 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	Missing/unknown	2 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	3 (severe)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	0 (none)	8 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	1 (mild)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	1 (mild)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	2 (moderate)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	1 (mild)	1 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	0 (none)	9 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	2 (moderate)	2 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	1 (mild)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	3 (severe)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	3 (severe)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	0 (none)	10 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	Missing/unknown	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	3 (severe)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	0 (none)	12 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	Missing/unknown	4 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	2 (moderate)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	1 (mild)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	2 (moderate)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	1 (mild)	2 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	3 (severe)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	Missing/unknown	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	2 (moderate)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	1 (mild)	1 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	0 (none)	6 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	2 (moderate)	3 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	1 (mild)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	2 (moderate)	2 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	1 (mild)	1 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	3 (severe)	1 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	Missing/unknown	4 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	0 (none)	6 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	3 (severe)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	2 (moderate)	2 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	1 (mild)	2 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	Missing/unknown	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	3 (severe)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	0 (none)	6 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	3 (severe)	3 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	1 (mild)	3 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	0 (none)	6 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	0 (none)	6 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	3 (severe)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	3 (severe)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	2 (moderate)	1 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	Missing/unknown	3 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	3 (severe)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	1 (mild)	3 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	3 (severe)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	Missing/unknown	2 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	Missing/unknown	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	2 (moderate)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	Missing/unknown	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	2 (moderate)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	1 (mild)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	2 (moderate)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	1 (mild)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	Missing/unknown	4 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	2 (moderate)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	3 (severe)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	0 (none)	12 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	0 (none)	8 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	Missing/unknown	3 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	2 (moderate)	1 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	Missing/unknown	2 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	Missing/unknown	3 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	0 (none)	8 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	3 (severe)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	1 (mild)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	0 (none)	9 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	Missing/unknown	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	0 (none)	8 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	0 (none)	12 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	3 (severe)	1 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	2 (moderate)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	0 (none)	8 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	Missing/unknown	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	1 (mild)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	2 (moderate)	1 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	3 (severe)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	2 (moderate)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	1 (mild)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	0 (none)	12 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	2 (moderate)	1 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	1 (mild)	3 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	Missing/unknown	4 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	3 (severe)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	2 (moderate)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	1 (mild)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	3 (severe)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	Missing/unknown	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	0 (none)	8 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	Missing/unknown	3 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	3 (severe)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	2 (moderate)	0 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	Missing/unknown	3 Participants
Cohort 1: NVN1000 8% Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	0 (none)	6 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	0 (none)	13 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	0 (none)	23 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	Missing/unknown	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	0 (none)	16 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	1 (mild)	4 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	2 (moderate)	2 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	Missing/unknown	1 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	0 (none)	14 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	1 (mild)	4 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	2 (moderate)	3 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	Missing/unknown	2 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	1 (mild)	3 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	2 (moderate)	2 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	Missing/unknown	5 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	1 (mild)	2 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	Missing/unknown	4 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	Missing/unknown	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	0 (none)	22 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	1 (mild)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	2 (moderate)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	0 (none)	19 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	1 (mild)	2 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	2 (moderate)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	Missing/unknown	2 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	0 (none)	18 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	1 (mild)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	2 (moderate)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	Missing/unknown	5 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	0 (none)	18 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	1 (mild)	1 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	2 (moderate)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	Missing/unknown	4 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	0 (none)	23 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	1 (mild)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	2 (moderate)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	Missing/unknown	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	0 (none)	18 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	1 (mild)	4 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	2 (moderate)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	Missing/unknown	1 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	0 (none)	18 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	1 (mild)	2 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	3 (severe)	1 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	Missing/unknown	2 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	2 (moderate)	1 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	Missing/unknown	5 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	2 (moderate)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	1 (mild)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	2 (moderate)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	1 (mild)	5 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	Missing/unknown	1 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	0 (none)	15 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	Missing/unknown	2 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	Missing/unknown	5 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	2 (moderate)	3 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	Missing/unknown	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	0 (none)	16 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	2 (moderate)	1 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	1 (mild)	3 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	2 (moderate)	3 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	0 (none)	13 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	1 (mild)	3 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	2 (moderate)	2 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	0 (none)	13 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	1 (mild)	3 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	1 (mild)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	2 (moderate)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	0 (none)	15 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	2 (moderate)	2 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	0 (none)	23 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	1 (mild)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	2 (moderate)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	Missing/unknown	1 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	2 (moderate)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	0 (none)	15 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	1 (mild)	2 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	Missing/unknown	4 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	0 (none)	16 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	1 (mild)	3 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	3 (severe)	0 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	Missing/unknown	4 Participants
Cohort 2: NVN1000 8% Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	0 (none)	23 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	2 (moderate)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	2 (moderate)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	Missing/unknown	5 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	0 (none)	10 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	0 (none)	9 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	2 (moderate)	1 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	2 (moderate)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	Missing/unknown	3 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	0 (none)	6 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	1 (mild)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	2 (moderate)	2 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	2 (moderate)	2 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	1 (mild)	1 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	Missing/unknown	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	Missing/unknown	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	2 (moderate)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	1 (mild)	7 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	1 (mild)	2 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	0 (none)	14 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	1 (mild)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	0 (none)	8 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	2 (moderate)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	0 (none)	14 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	0 (none)	8 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	1 (mild)	2 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	1 (mild)	2 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	2 (moderate)	1 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	1 (mild)	2 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	0 (none)	8 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	1 (mild)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	Missing/unknown	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	0 (none)	8 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	0 (none)	11 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	0 (none)	14 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	1 (mild)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	Missing/unknown	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	1 (mild)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	Missing/unknown	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	Missing/unknown	5 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	2 (moderate)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	0 (none)	8 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	0 (none)	11 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	Missing/unknown	1 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	2 (moderate)	1 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	Missing/unknown	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	1 (mild)	1 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	0 (none)	13 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	2 (moderate)	1 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	1 (mild)	1 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	Missing/unknown	1 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	0 (none)	12 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	Missing/unknown	1 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	1 (mild)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	2 (moderate)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	Missing/unknown	3 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	Missing/unknown	3 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	Missing/unknown	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	1 (mild)	1 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	2 (moderate)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	2 (moderate)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	1 (mild)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	2 (moderate)	1 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	0 (none)	14 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	2 (moderate)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	Missing/unknown	5 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	Missing/unknown	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	0 (none)	8 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	2 (moderate)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	1 (mild)	4 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	2 (moderate)	1 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	0 (none)	11 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	0 (none)	6 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	2 (moderate)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	Missing/unknown	5 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	1 (mild)	3 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	Missing/unknown	1 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	1 (mild)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	3 (severe)	0 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	0 (none)	14 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	Missing/unknown	3 Participants
Cohort 3: NVN1000 16% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	1 (mild)	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	Missing/unknown	7 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	2 (moderate)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	0 (none)	20 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	Missing/unknown	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	Missing/unknown	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	2 (moderate)	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	0 (none)	28 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	3 (severe)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	Missing/unknown	7 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	0 (none)	19 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	0 (none)	24 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	1 (mild)	2 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	Missing/unknown	2 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	3 (severe)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	1 (mild)	4 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	1 (mild)	3 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	2 (moderate)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	0 (none)	19 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	Missing/unknown	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	3 (severe)	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	Missing/unknown	4 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	2 (moderate)	2 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	0 (none)	26 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	Missing/unknown	7 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	0 (none)	17 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	2 (moderate)	3 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	1 (mild)	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	3 (severe)	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	Missing/unknown	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	3 (severe)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	Missing/unknown	2 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	1 (mild)	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	Missing/unknown	7 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	3 (severe)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	0 (none)	18 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	2 (moderate)	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	1 (mild)	10 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	3 (severe)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	1 (mild)	5 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	0 (none)	24 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	3 (severe)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	1 (mild)	3 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	1 (mild)	9 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	1 (mild)	2 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	3 (severe)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	2 (moderate)	2 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	3 (severe)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	3 (severe)	3 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	1 (mild)	3 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	2 (moderate)	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	0 (none)	27 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	Missing/unknown	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	0 (none)	19 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	3 (severe)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	1 (mild)	4 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	0 (none)	19 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	3 (severe)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	Missing/unknown	4 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	1 (mild)	6 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	Missing/unknown	4 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	1 (mild)	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	0 (none)	20 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	Missing/unknown	4 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	2 (moderate)	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	1 (mild)	6 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	1 (mild)	2 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	Missing/unknown	2 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	0 (none)	28 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	3 (severe)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	3 (severe)	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	Missing/unknown	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	1 (mild)	3 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	3 (severe)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	2 (moderate)	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	Missing/unknown	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	Missing/unknown	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	0 (none)	25 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	0 (none)	20 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	3 (severe)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	3 (severe)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	0 (none)	27 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	2 (moderate)	2 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	3 (severe)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	0 (none)	28 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	1 (mild)	2 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	1 (mild)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	0 (none)	18 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	2 (moderate)	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	2 (moderate)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	2 (moderate)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	Missing/unknown	2 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	2 (moderate)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	2 (moderate)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	1 (mild)	2 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	2 (moderate)	2 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	3 (severe)	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	2 (moderate)	1 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	2 (moderate)	0 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	2 (moderate)	4 Participants
Cohort 4: NVN1000 24% Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	0 (none)	20 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	1 (mild)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	Missing/unknown	1 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	Missing/unknown	3 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	0 (none)	16 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	1 (mild)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	0 (none)	20 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	Missing/unknown	4 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	0 (none)	20 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	1 (mild)	1 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	1 (mild)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	Missing/unknown	1 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	Missing/unknown	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	0 (none)	16 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	0 (none)	19 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	Missing/unknown	1 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	0 (none)	20 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	0 (none)	19 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	1 (mild)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	1 (mild)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	1 (mild)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	1 (mild)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	1 (mild)	4 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	1 (mild)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	Missing/unknown	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	0 (none)	16 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	Missing/unknown	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	Missing/unknown	1 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	2 (moderate)	1 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	0 (none)	19 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	1 (mild)	1 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	Missing/unknown	4 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	Missing/unknown	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	0 (none)	15 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	Missing/unknown	1 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	Missing/unknown	1 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	1 (mild)	3 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	0 (none)	13 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	1 (mild)	3 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	2 (moderate)	1 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	Missing/unknown	3 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	0 (none)	20 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	0 (none)	14 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	1 (mild)	1 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	0 (none)	20 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	1 (mild)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	0 (none)	18 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	1 (mild)	2 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	0 (none)	20 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	0 (none)	18 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	1 (mild)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	Missing/unknown	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	Missing/unknown	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	0 (none)	19 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	1 (mild)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	Missing/unknown	1 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	0 (none)	19 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	1 (mild)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	2 (moderate)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	3 (severe)	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	Missing/unknown	3 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	Missing/unknown	1 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	Missing/unknown	0 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	0 (none)	17 Participants
Vehicle Gel Once Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	0 (none)	4 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	0 (none)	4 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	1 (mild)	2 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	0 (none)	3 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	1 (mild)	2 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	0 (none)	4 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	0 (none)	4 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Baseline	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	0 (none)	4 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	0 (none)	4 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 8	0 (none)	4 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 4	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 2	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 2	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	0 (none)	4 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	0 (none)	4 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	0 (none)	4 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Week 4	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	0 (none)	4 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 8	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/ulceration: Week 12	0 (none)	4 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 8	0 (none)	2 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	0 (none)	4 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 4	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Edema: Week 12	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	0 (none)	4 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 4	1 (mild)	1 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Baseline	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	2 (moderate)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 12	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Week 2	0 (none)	2 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erosion/Ulceration: Baseline	0 (none)	4 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Burning/stinging: Baseline	Missing/unknown	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	0 (none)	4 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 8	3 (severe)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 12	1 (mild)	0 Participants
Vehicle Gel Twice Daily	Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch	Erythema: Week 2	0 (none)	4 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Topical NVN1000 for the Treatment of External Genital and Perianal Warts

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Efficacy: Complete Clearance of Baseline External Genital and Perianal Warts at or Before Week 12

Percentage of Subjects With Complete Clearance of Total EGW/PAW at or Before Week 12

Percentage of Subjects With Complete or Partial Clearance of Baseline Warts at or Before Week 12

Safety as Determined by Changes in Laboratory Assessments

Tolerability of Topical NVN1000 Gel as Determined by Scores on a 4 Point Grading Scale for Erythema, Edema, Erosions/Ulcers, and Itch