Cantharidin Application in Molluscum Patients

Molluscum Contagiosum Clinical Trial

— CAMP-2  

Official title:

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Pivotal Study to Evaluate the Safety and Efficacy of VP-102 Topical Film-Forming Solution [0.7% (w/v) Cantharidin] in Subjects (2 Years and Older) With Molluscum Contagiosum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03377803
• Other study ID #: VP-102-102
• Status: Completed
• Phase: Phase 3
• Start date: February 14, 2018
• Est. completion date: September 26, 2018

Study information

• Verified date: November 2021
• Source: Verrica Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a Phase 3, randomized, double-blind, placebo-controlled, pivotal study to evaluate the safety and efficacy of VP-102 topical film-forming solution in subjects with Molluscum Contagiosum. VP-102 will be applied once every 21 days for up to 4 applications, to treatable molluscum contagiosum (molluscum) lesions on subjects 2 years and older. Efficacy will be assessed as the proportion of subjects achieving complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit.

Description:

This is a Phase 3, multi-center, randomized, double-blind, placebo (vehicle)-controlled, pivotal study that will be conducted in the United States to determine the efficacy and safety of VP-102 following treatment of molluscum lesions for up to 4 treatments, every 21 days, with VP-102/placebo in 250 subjects. Subjects will receive active VP-102 or placebo in a 3:2 ratio. Study drug (VP-102 or placebo) will be supplied in single-use applicators.

The film-forming Study drug solution will be applied and left on the lesions for 24 hours before the subject and/or parents/guardian washes the lesions. Study drug may be removed prior to the 24-hour time point in the event treatment-emergent AEs are experienced.

Molluscum lesions will be treated without occlusion in all anatomic areas including the face, trunk, back, arms, legs, hands, feet, anogenital region and buttocks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: September 26, 2018
• Est. primary completion date: September 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

To qualify for inclusion in this study, subjects must:

1. Be healthy subjects, at least 2 years of age or older.

2. Consent to having all molluscum lesions treated and the physician must be willing to treat all molluscum lesions initially present. Lesions within 10mm of the eyelid margins or the margin of any mucosal membrane should be evaluated carefully to ensure that they can be safely treated. Non-mucosal genital area lesions and inflamed lesions are considered treatable.

3. Be otherwise medically healthy with no clinically significant medical history as determined by the investigator. Subjects exhibiting active Atopic Dermatitis may be enrolled.

4. On day of treatment 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 within 5cm of treated skin lesions.

5. Refrain from swimming, bathing or prolonged immersion in water or any liquids until the Study drug is removed.

6. Have the ability or have a guardian with the ability to follow study instructions and be likely to complete all study requirements.

7. Provide written informed consent or assent in a manner approved by the institutional review board (IRB) and/or have a parent/guardian provide written informed consent as evidenced by the signature on an IRB approved assent/consent form.

8. Provide written authorization for use and disclosure of protected health information.

9. Agree to allow photographs to be taken, (selected sites only) of selected lesions at every visit that will be used for training, publication and future marketing brochures.

Exclusion Criteria:

Subjects will be excluded from the study if they:

1. Are unable to cooperate with the requirements or visits of the study, as determined by the investigator.

2. Are systemically immunosuppressed or are receiving treatments such as chemotherapy or other non-topical immunosuppressive agents.

3. Have any lesions present at baseline in anatomic locations that the subject/parent/guardian or the physician is unwilling to treat.

4. Have had any previous treatment of molluscum including the use of cantharidin, antivirals, retinoids, curettage or freezing of lesions in the past 14 days. Additional treatments should not be implemented during the course of the study.

5. Have a 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.

6. 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.

7. Have a history or presence of hypersensitivity or an idiosyncratic reaction to the Study drug or related compounds, or drug product excipients (acetone, ethyl alcohol, nitrocellulose, hydroxypropyl cellulose, castor oil, camphor, gentian violet, and denatonium benzoate).

8. Have a condition or situation that may interfere significantly with the subject's participation in the study (e.g., subjects 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.

9. Have received another investigational product within 14 days prior to the first application of the Study drug.

10. Have been treated within 14 days with a product that contains cantharidin (topical or homeopathic preparations) for any reason prior to screening.

11. Are sexually active or may become sexually active and are unwilling to practice responsible birth control methods. (e.g., combination of condoms and foam, birth control pills, intrauterine device, patch, shot and vaginal ring, etc.). Withdrawal is not an acceptable method of birth control. Females that have reached menarche must have a negative urine pregnancy test at each visit prior to treatment with Study drug.

12. Are pregnant or breastfeeding.

Related Conditions & MeSH terms

• Molluscum Contagiosum

Intervention

Combination Product:
• VP-102 - Cantharidin, Topical Film Forming Solution
VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Up to 4 applications of VP-102 will be administered to Molluscum lesions at 21-day intervals.
• Placebo -Topical Film Forming Solution without VP-102
Placebo a single-use drug device combination product containing only the vehicle. Up to 4 applications of Placebo will be administered to Molluscum lesions at 21-day intervals.

Locations

Country	Name	City	State
United States	Tekton Research	Austin	Texas
United States	Bakersfield Dermatology	Bakersfield	California
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Dermatology Center of Northwestern Indiana	Crown Point	Indiana
United States	Pedia Research	Evansville	Indiana
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Solution Through Advanced Research	Jacksonville	Florida
United States	Midwest Children's Health	Lincoln	Nebraska
United States	Midwest Children's Health-Northwoods	Lincoln	Nebraska
United States	DCOL Center for Clinical Research	Longview	Texas
United States	The Education and Research Foundation	Lynchburg	Virginia
United States	Pedia Research	Owensboro	Kentucky
United States	Rady Children's Hospital	San Diego	California
United States	Redwood Family Dermatology	Santa Rosa	California
United States	Lenus Research and Medical Group	Sweetwater	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Verrica Pharmaceuticals Inc.	Database Integrations, Inc., Instat Consulting, Inc., Paidion Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline of the Composite Score From the Children's Dermatology Life Quality Index (CDLQI) Assessment at the EOS Visit to Measure the Quality of Life and Impact of Skin Disease in the Subset of Subjects 4 -16 Years of Age	Change from Baseline to EOS Day 84 of the Composite Score From the Children's Dermatology Life Quality Index (CDLQI) Assessment at the EOS Visit to Measure the Quality of Life and Impact of Skin Disease in the Subset of Subjects 4 -16 Years of Age.; 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 Larger composite CDLQI scores indicate skin condition is having more effect on subjects' lives (worse outcome).	Day 1 (Baseline), 21, 42, 63 and Day 84 (EOS)
Other	Percent Change of All Treatable Molluscum Lesions (Baseline and New) From Baseline at the EOS Visit	Percent change of all treatable molluscum lesions (baseline and new) from baseline at the EOS visit.	Day 1 (Baseline) compared to Day 84 (EOS)
Other	Change From Baseline in the Number of Treatable Molluscum Lesions (Baseline and New) at the EOS Visit	Change from baseline in the number of treatable molluscum lesions (baseline and new) at the EOS visit.	Day 1 (Baseline) compared to Day 84 (EOS)
Other	Percentage of Subjects Exhibiting a 75% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit	Percentage of subjects exhibiting a 75% or greater reduction of all treatable molluscum lesions (baseline and new) at the EOS visit.	Day 1 (Baseline) compared to Day 84(EOS)
Other	Percentage of Subjects Exhibiting a 90% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit	Percentage of subjects exhibiting a 90% or greater reduction of all treatable molluscum lesions (baseline and new) at the EOS visit.	Day 1 (Baseline) compared to Day 84 (EOS)
Other	Subject Reported Spread to Household Members as Measured by Any New Occurrence of Molluscum in Household Members of Subject	Subject reported spread to household members as measured by any new occurrence of molluscum in household members of subject.	Days 1, 21, 42, 63 and 84 (EOS).
Primary	Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS)	Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit (EOS).	Day 1 (Baseline) compared to Day 84 (EOS)
Secondary	Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit	Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 63 visit.	Day 1 (Baseline) compared to Day 63
Secondary	Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit	Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 42 visit.	Day 1 (Baseline) compared to Day 42
Secondary	Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit	Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 21 visit.	Day 1 (Baseline) compared to Day 21