Evaluation of Systemic Exposure to VP-102 in Subjects With Molluscum Contagiosum.

A Phase 2, Open-Label Study to Evaluate the Safety, Efficacy and Systemic Exposure of VP-102 Topical Film Forming Solution [0.7% (w/v) Cantharidin] in Subjects (2 Years and Older) With Molluscum Contagiosum

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03186378

Enrollment

Registered

2017-06-14

Start date

2017-06-08

Completion date

2018-06-25

Last updated

2021-08-11

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

Conditions

Molluscum Contagiosum

Brief summary

The primary objective of the study is to determine the presence or absence of systemic cantharidin exposure from a single 24-hour dermal application of VP-102 topical film-forming solution \[0.7% (w/v) cantharidin\] (VP-102) when applied to molluscum contagiosum (molluscum) lesions on pediatric subjects 2 years old and older. Treatment will continue over the course of 3 additional 21 day intervals allowing for further evaluation of safety, efficacy and impact on quality of life.

Detailed description

This is a Phase 2, Open-Label Study to Evaluate the Safety, Efficacy and Systemic Exposure of VP-102 Topical Film Forming Solution \[0.7% (w/v) cantharidin\] in subjects 2 years and older with Molluscum Contagiosum. Up to 40 subjects will be enrolled in the study with the goal of 16 meeting criteria for, and completing all scheduled blood draws outlined in the exposure portion of the trial. Subjects that do not have enough molluscum lesions to participate in the exposure study but do meet all other criteria to participate in the study will be enrolled in the standard treatment group. No more than 16 subjects will complete exposure group activities; up to 16 subjects will be enrolled in the standard treatment group. The additional 8 subjects may be used for replacement patients. At least 3 patients in the exposure group will be from 2-5 years of age. All subjects will receive VP-102 containing 0.7% cantharidin to molluscum lesions every 21 days for a maximum of 4 sessions or until complete clearance. In the exposure group, blood samples for systemic exposure evaluation will be collected on Day 1, prior to the drug application, and 2 (± 30 minutes), 6 (± 1 hour) and 24 (±3 hours) hours post-application. A dermatological examination will be performed by a qualified investigator quantifying molluscum lesion counts at every study visit.

Interventions

COMBINATION_PRODUCTVP-102 with applicator

Subjects will receive treatment to their molluscum contagiosum with VP-102.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Open label

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Be healthy subjects ages 2 years and older. 2. Patients with 1-20 lesions may be enrolled and treated in the standard treatment group but are not eligible for the exposure study. 3. Patients with 21 or more lesions may only be enrolled in the exposure group. Subjects participating in the Exposure group must have at least 21 lesions treated at Day 1 to qualify. 4. Be otherwise medically healthy with no clinically significant medical history as determined by the investigator. Patients exhibiting active Atopic Dermatitis may be enrolled. 5. Refrain from application of all topical agents including alcohol-based sanitary products and sunscreens for a minimum of 4 hours before Study drug application. Topical agents including alcohol-based sanitary products and sunscreens may be used after application of the study drug so long as they are not applied to or near treated skin. 6. Refrain from swimming, bathing or prolonged immersion in water until the Study drug is removed. 7. Have the ability or have a guardian able to follow study instructions and be likely to complete all study requirements. 8. Provide assent in a manner approved by the institutional review board (IRB) and have a parent/guardian provide written informed consent as evidenced by signature on IRB approved assent/consent forms. 9. Provide written authorization for use and disclosure of protected health information. 10. Agree to allow photographs of all selected lesions to be taken and/or send photos via text or email to the study team for assessment at 24 hours post treatment. Photos may be used as part of the study data and/or marketing package. (Photographs will be de-identified to those outside the research team. Effort will be made to ensure that no photos with identifiable features are obtained).

Exclusion criteria

1. Are unable to cooperate with the requirements or visits of the study, as determined by the investigator. 2. Have molluscum venereum (sexually transmitted molluscum). 3. Have active molluscum eczema. 4. Are systemically immunosuppressed or are receiving treatments such as chemotherapy or other non-topical immunosuppressive agents. 5. Have had any previous treatment of molluscum in the past 14 days including the use of cantharidin, antivirals, retinoids, curettage or freezing of lesions. Additional treatments for molluscum should not be implemented during the course of the study. 6. Have history of illness or any dermatologic disorder, which, in the opinion of the investigator will interfere with accurate counting of lesions or increase the risk of adverse events. 7. History or presence of clinically significant medical, psychiatric, or emotional condition or abnormality that in the opinion of the investigator would compromise the safety of the subject or the quality of the data. 8. Have a history or presence of hypersensitivity or an idiosyncratic reaction to the Study drug or related compounds, or drug product excipients. 9. Have a condition or situation that may interfere significantly with the subject's participation in the study (e.g., patients who required hospitalization in the 2 months prior to screening for an acute or chronic condition including alcohol or drug abuse), at the discretion of the investigator. 10. Have received another investigational product within 14 days prior to the first application of the Study drug. 11. Have been treated within 14 days with a product that contains the active ingredient in VP-102 (topical or homeopathic preparations) for any reason prior to screening. 12. Are sexually active or may become sexually active and are unwilling to practice responsible birth control methods. Females that have reached menarche, must have a negative urine pregnancy test at screening and each visit prior to treatment with study medication. 13. Are pregnant or breastfeeding.

Design outcomes

Primary

Measure	Time frame	Description
The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.	24 hours	The primary objective is to determine any potential systemic exposure from a single 24-hour dermal application of VP-102 topical film-forming solution when applied to molluscum contagiosum (molluscum) lesions on pediatric subjects 2 years old and older.

Secondary

Measure	Time frame	Description
Measurement of Efficacy - Complete Clearance	Baseline through EOS Day 84	Proportion of subjects exhibiting complete clearance of all treated molluscum lesions (baseline and new) on or before Week 12 (EOS).

Other

Measure	Time frame	Description
Change From Baseline in the Number of Treated Molluscum Lesions at the EOS Visit.	Baseline to EOS Day 84	Molluscum Lesions- Change from Baseline visit in the number of treated molluscum lesions at the EOS Day 84 visit
Proportion of Subjects Exhibiting a 90% or Greater Reduction of All Treated Molluscum Lesions (Baseline and New) at the EOS Visit.	Baseline to EOS Day 84	Summaries of \>=90% clearance by visit include clearance at that visit or any earlier visit (cumulative) baseline and ew at the EOS visit.
Spread to Siblings as Measured by Any New Occurrence of Molluscum in Siblings of the Subject.	Baseline to EOS Day 84	Spread of molluscum to siblings as measured by any new occurrence of molluscum in siblings of the subject.
Change From Baseline in Quality of Life and Impact of Skin Disease as Measured by CDLQI Assessment	Baseline to EOS Day 84	Change from Baseline in quality of life and impact of skin disease as measured by CDLQI assessment, Children's Dermatology Life Quality Index (CDLQI)- Composite Score The CDLQI was a 10-item questionnaire completed by subject/parent to assess skin condition over the previous week. From responses to that questionnaire, a composite score was calculated. The calculated composite score was the sum of the individual 10 items of the CDLQI and could range from 0-30. For each item on the CDLQI, a score of 0-3 was assigned using the following scores per response: * 3: Very much (or Prevented School, Question 7 only) * 2: Quite a lot * 1: Only a little * 0: Not at all
Percent Reduction of Treated Molluscum Lesions From Baseline at the EOS Visit.	Baseline to EOS Day 84	Percent reduction of treated molluscum lesions from Baseline Visit at the EOS visit.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Exposure Group This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator. VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.	17
Standard Group This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator. VP-102 with applicator: Subjects will receive treatment to their molluscum contagiosum with VP-102.	16
Total	33

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	0

Baseline characteristics

Characteristic	Exposure Group	Standard Group	Total
Age, Continuous	6.6 years STANDARD_DEVIATION 3.45	6.8 years STANDARD_DEVIATION 3.15	6.7 years STANDARD_DEVIATION 3.26
Baseline Number of Molluscum Lesions	47.4 molluscum lesions STANDARD_DEVIATION 25.69	11.6 molluscum lesions STANDARD_DEVIATION 6.33	30.0 molluscum lesions STANDARD_DEVIATION 26.07
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	2 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants	14 Participants	31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	2 Participants	3 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	16 Participants	14 Participants	30 Participants
Region of Enrollment United States	17 Participants	16 Participants	33 Participants
Sex: Female, Male Female	7 Participants	8 Participants	15 Participants
Sex: Female, Male Male	10 Participants	8 Participants	18 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 17	0 / 16
other Total, other adverse events	16 / 17	13 / 16
serious Total, serious adverse events	0 / 17	0 / 16

Outcome results

Primary

The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.

The primary objective is to determine any potential systemic exposure from a single 24-hour dermal application of VP-102 topical film-forming solution when applied to molluscum contagiosum (molluscum) lesions on pediatric subjects 2 years old and older.

Time frame: 24 hours

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Exposure Group	The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.	Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) Pre-treatment	Yes	0 Participants
Exposure Group	The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.	Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) Pre-treatment	No	16 Participants
Exposure Group	The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.	Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) 2hr Post Treatment	Yes	1 Participants
Exposure Group	The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.	Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) 2hr Post Treatment	No	15 Participants
Exposure Group	The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.	Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) 6hr Post Treatment	Yes	0 Participants
Exposure Group	The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.	Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) 6hr Post Treatment	No	16 Participants
Exposure Group	The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.	Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) 24hr Post Treatment	Yes	0 Participants
Exposure Group	The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.	Any Concentration Level of VP-102 above LLOQ (2.5ng/ml) 24hr Post Treatment	No	16 Participants

Secondary

Measurement of Efficacy - Complete Clearance

Proportion of subjects exhibiting complete clearance of all treated molluscum lesions (baseline and new) on or before Week 12 (EOS).

Time frame: Baseline through EOS Day 84

Population: Complete Clearance of Molluscum Lesions - Completer Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Exposure Group	Measurement of Efficacy - Complete Clearance	Complete Clearance Day 21	0 Participants
Exposure Group	Measurement of Efficacy - Complete Clearance	Complete Clearance Day 42	2 Participants
Exposure Group	Measurement of Efficacy - Complete Clearance	Complete Clearance Day 63	4 Participants
Exposure Group	Measurement of Efficacy - Complete Clearance	Complete Clearance EOS Day 84	6 Participants
Standard Group	Measurement of Efficacy - Complete Clearance	Complete Clearance EOS Day 84	10 Participants
Standard Group	Measurement of Efficacy - Complete Clearance	Complete Clearance Day 21	3 Participants
Standard Group	Measurement of Efficacy - Complete Clearance	Complete Clearance Day 63	9 Participants
Standard Group	Measurement of Efficacy - Complete Clearance	Complete Clearance Day 42	7 Participants

Other Pre-specified

Change From Baseline in Quality of Life and Impact of Skin Disease as Measured by CDLQI Assessment

Change from Baseline in quality of life and impact of skin disease as measured by CDLQI assessment, Children's Dermatology Life Quality Index (CDLQI)- Composite Score The CDLQI was a 10-item questionnaire completed by subject/parent to assess skin condition over the previous week. From responses to that questionnaire, a composite score was calculated. The calculated composite score was the sum of the individual 10 items of the CDLQI and could range from 0-30. For each item on the CDLQI, a score of 0-3 was assigned using the following scores per response: * 3: Very much (or Prevented School, Question 7 only) * 2: Quite a lot * 1: Only a little * 0: Not at all