Ignite Creation Date:
2024-05-06 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03377803
Status:
COMPLETED
Last Update Posted:
2021-12-14
First Post:
2017-12-13
Brief Title:
Cantharidin Application in Molluscum Patients
Sponsor:
Verrica Pharmaceuticals Inc
Organization:
Verrica Pharmaceuticals Inc
Study Overview
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 07 wv Cantharidin in Subjects 2 Years and Older With Molluscum Contagiosum
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMP-2
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
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-102placebo in 250 subjects Subjects will receive active VP-102 or placebo in a 32 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 andor parentsguardian 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
The film-forming Study drug solution will be applied and left on the lesions for 24 hours before the subject andor parentsguardian 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None