Molluscum Contagiosum Clinical Trial
— CAMP-1Official 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
Verified date | December 2021 |
Source | Verrica Pharmaceuticals Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 266 |
Est. completion date | November 26, 2018 |
Est. primary completion date | November 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. |
Country | Name | City | State |
---|---|---|---|
United States | Arlington Research Center | Arlington | Texas |
United States | Alabama Clinical Therapeutics | Birmingham | Alabama |
United States | Study Protocol, Inc., | Boynton Beach | Florida |
United States | Holston Medical Group | Bristol | Tennessee |
United States | Kings County Hospital | Brooklyn | New York |
United States | University North Carolina Dermatology Center | Chapel Hill | North Carolina |
United States | Clarkston Skin Research | Clarkston | Michigan |
United States | Skin Research Institute | Coral Gables | Florida |
United States | Southeastern Pediatric Associates | Dothan | Alabama |
United States | The Pediatric Associates of Fairfield, Inc | Fairfield | Ohio |
United States | Center for Skin Research | Houston | Texas |
United States | Midwest Children's Hospital | Lincoln | Nebraska |
United States | Applied Research Center of Arkansas | Little Rock | Arkansas |
United States | Summit Dermatology | Oakbrook Terrace | Illinois |
United States | ACRC Trials Plano Pediatrics | Plano | Texas |
United States | St Louis Children's Hospital | Saint Louis | Missouri |
United States | ASCLEPES Research Center | Spring Hill | Florida |
United States | Olympian Clinical Research | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Verrica Pharmaceuticals Inc. | Database Integrations, Inc., Instat Consulting, Inc., Paidion Research, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | 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). |
Baseline to 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 that exhibited a 75% or greater clearance 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 that exhibited a 90% or greater clearance 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. To be eligible for assessment, subjects had to have at least one household member free of lesions at baseline and have at least 1 post baseline assessment of spread of molluscum lesions. | 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 and new) 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 and new) 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 and new) compared to Day 42 | |
Secondary | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit | Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 21 visit. | Day 1 (Baseline and new) compared to Day 21 |
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