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Cantharidin Application in Molluscum Patients (CAMP-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03377803
Recruitment Status : Completed
First Posted : December 19, 2017
Results First Posted : December 14, 2021
Last Update Posted : December 14, 2021
Sponsor:
Collaborators:
Instat Consulting, Inc.
Paidion Research, Inc.
Database Integrations, Inc.
Information provided by (Responsible Party):
Verrica Pharmaceuticals Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Molluscum Contagiosum Combination Product: VP-102 - Cantharidin, Topical Film Forming Solution Combination Product: Placebo -Topical Film Forming Solution without VP-102 Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 14, 2018
Actual Primary Completion Date : September 26, 2018
Actual Study Completion Date : September 26, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Cantharidin

Arm Intervention/treatment
Active Comparator: VP-102
VP-102 is contained within a single-use applicator. The VP-102 applicator consists of a plastic tube containing a sealed glass ampule and an applicator tip. One ampule contains 450 μL of VP-102 (0.7% [w/v] cantharidin) solution.
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 Comparator: Placebo
Placebo is contained within a single-use applicator. The placebo applicator consists of a plastic tube containing a sealed glass ampule and an applicator tip. One ampule contains 450μl of placebo solution with the same color and consistency as VP-102.
Combination Product: 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.




Primary Outcome Measures :
  1. Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS) [ Time Frame: Day 1 (Baseline) compared to Day 84 (EOS) ]
    Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit (EOS).


Secondary Outcome Measures :
  1. Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit [ Time Frame: Day 1 (Baseline) compared to Day 63 ]
    Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 63 visit.

  2. Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit [ Time Frame: Day 1 (Baseline) compared to Day 42 ]
    Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 42 visit.

  3. Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit [ Time Frame: Day 1 (Baseline) compared to Day 21 ]
    Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 21 visit.


Other Outcome Measures:
  1. 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 [ Time Frame: Day 1 (Baseline), 21, 42, 63 and Day 84 (EOS) ]

    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).

  2. Percent Change of All Treatable Molluscum Lesions (Baseline and New) From Baseline at the EOS Visit [ Time Frame: Day 1 (Baseline) compared to Day 84 (EOS) ]
    Percent change of all treatable molluscum lesions (baseline and new) from baseline at the EOS visit.

  3. Change From Baseline in the Number of Treatable Molluscum Lesions (Baseline and New) at the EOS Visit [ Time Frame: Day 1 (Baseline) compared to Day 84 (EOS) ]
    Change from baseline in the number of treatable molluscum lesions (baseline and new) at the EOS visit.

  4. Percentage of Subjects Exhibiting a 75% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit [ Time Frame: Day 1 (Baseline) compared to Day 84(EOS) ]
    Percentage of subjects exhibiting a 75% or greater reduction of all treatable molluscum lesions (baseline and new) at the EOS visit.

  5. Percentage of Subjects Exhibiting a 90% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit [ Time Frame: Day 1 (Baseline) compared to Day 84 (EOS) ]
    Percentage of subjects exhibiting a 90% or greater reduction of all treatable molluscum lesions (baseline and new) at the EOS visit.

  6. Subject Reported Spread to Household Members as Measured by Any New Occurrence of Molluscum in Household Members of Subject [ Time Frame: Days 1, 21, 42, 63 and 84 (EOS). ]
    Subject reported spread to household members as measured by any new occurrence of molluscum in household members of subject.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377803


Locations
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United States, California
Bakersfield Dermatology
Bakersfield, California, United States, 93309
Rady Children's Hospital
San Diego, California, United States, 92123
Redwood Family Dermatology
Santa Rosa, California, United States, 95403
United States, Florida
Solution Through Advanced Research
Jacksonville, Florida, United States, 32256
Lenus Research and Medical Group
Sweetwater, Florida, United States, 33172
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Indiana
Dermatology Center of Northwestern Indiana
Crown Point, Indiana, United States, 46307
Pedia Research
Evansville, Indiana, United States, 47715
United States, Kentucky
Pedia Research
Owensboro, Kentucky, United States, 42301
United States, Michigan
Hamzavi Dermatology
Fort Gratiot, Michigan, United States, 48059
United States, Nebraska
Midwest Children's Health-Northwoods
Lincoln, Nebraska, United States, 68505
Midwest Children's Health
Lincoln, Nebraska, United States, 68505
United States, Texas
Tekton Research
Austin, Texas, United States, 78745
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
United States, Virginia
The Education and Research Foundation
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Verrica Pharmaceuticals Inc.
Instat Consulting, Inc.
Paidion Research, Inc.
Database Integrations, Inc.
Investigators
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Principal Investigator: Lawrence Eichenfield, MD Rady Children's Hospital; San Diego, California
  Study Documents (Full-Text)

Documents provided by Verrica Pharmaceuticals Inc.:
Study Protocol  [PDF] February 1, 2018
Statistical Analysis Plan  [PDF] October 17, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Verrica Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03377803    
Other Study ID Numbers: VP-102-102
First Posted: December 19, 2017    Key Record Dates
Results First Posted: December 14, 2021
Last Update Posted: December 14, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Verrica Pharmaceuticals Inc.:
Molluscum
Skin Diseases
Poxviridae Infections
Skin Diseases; Infectious
Skin Diseases; Viral
DNA Poxvirus
Additional relevant MeSH terms:
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Molluscum Contagiosum
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Pharmaceutical Solutions
Cantharidin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action