A Phase 1, 3 Day Study of Safety and Tolerability of NVN1000 Topical Gel in Healthy Volunteers

A Phase One, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN10000 Topical Gel in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01755247

Enrollment

Registered

2012-12-24

Start date

2012-11-30

Completion date

2012-12-31

Last updated

2019-09-10

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

Conditions

Acne Vulgaris

Keywords

acne

Brief summary

A Phase I, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers

Detailed description

This is a 3 day study to assess safety and tolerability of a new topical gel product, NVN1000 with and without the application of a commercially available moisturizer in approximately 15 healthy subjects. The test product will be applied to the forehead of healthy volunteers once daily for 3 days. One group of subjects will have a moisturizer applied to the same area 15 minutes after the test gel was applied and one group of subjects will be treated with the gel vehicle which does not contain the active product. The hypothesis is that the application of moisturizer will not effect safety or local tolerability.

Interventions

DRUGTopical Gel Vehicle

DRUG8% NVN1000 Topical Gel

DRUG8% NVN1000 Topical Gel and moisturizer

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy Male and Females \> 18 years of age * High degree of fluorescence of facial skin under Wood's lamp

Exclusion criteria

* Acute or chronic skin disorders * Topical or systemic antibiotics within 4 weeks of study enrollment * Use of medication that increases risk of methemoglobinemia or influences P. acnes counts * Subjects with medical illnesses, anemia, elevated methemoglobin * Women who are pregnant, nursing or planning a pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Cutaneous tolerability	3 days	Tolerability based on a four point scale (0-3) for erythema, scaling ,dryness, pruritus, and burning/stinging.

Secondary

Measure	Time frame	Description
Safety comparison	3 Days	Assess safety through the comparison of adverse events between groups (lab assessments, physical exams and vital signs).

Other

Measure	Time frame	Description
Propionibacterium acnes counts	3 days	P. acnes counts will be obtained at Baseline, Day 1, and Day 3. The change in P acnes counts over time by treatment group will be assessed.

Countries

United States

Outcome results

None listed

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