Brief Summary
The purpose of this study is to determine if cantharidin is a safe and effective treatment for molluscum contagiosum in kids
Brief Title
Safety and Efficacy Study of Topical Cantharidin for the Treatment of Molluscum Contagiosum
Detailed Description
This was a double-blind, placebo-controlled trial. Participants were recruited from the Pediatric Dermatology clinic at Montefiore Medical Center. One hundred eligible participants were randomly assigned to receive cantharidin 0.7% topical, cantharidin 0.7% topical with occlusion, placebo, or placebo with occlusion. Treatments were applied at weeks 0 and 3 (blinded phase). At week 6, all participants were treated with open-label, topical cantharidin 0.7% without occlusion every 3 weeks until all lesions resolved (open-label phase).
Completion Date
Completion Date Type
Actual
Conditions
Molluscum Contagiosum
Eligibility Criteria
Inclusion Criteria:
* 2-17years
* Healthy
* \<50 molluscum contagiosum lesions
Exclusion Criteria:
* Immunosuppressed
* Oral corticosteroids
* Sexually active/pregnant
* 2-17years
* Healthy
* \<50 molluscum contagiosum lesions
Exclusion Criteria:
* Immunosuppressed
* Oral corticosteroids
* Sexually active/pregnant
Inclusion Criteria
Inclusion Criteria:
* 2-17years
* Healthy
* \<50 molluscum contagiosum lesions
* 2-17years
* Healthy
* \<50 molluscum contagiosum lesions
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
17 Years
Minimum Age
2 Years
NCT Id
NCT02665260
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
12-01-004
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Randomized Pilot Study Investigating the Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum
Primary Outcomes
Outcome Description
Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase)
Outcome Measure
Number of Subjects Who Achieve Complete Clearance at 6 Weeks
Outcome Time Frame
6 weeks
Secondary Outcomes
Outcome Description
Number of subjects who experienced an adverse event as assessed by patient-reported outcomes questionnaire at each visit
Outcome Time Frame
33 weeks
Outcome Measure
Number of Subjects Who Experienced an Adverse Event
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
17
Minimum Age Number (converted to Years and rounded down)
2
Investigators
Investigator Type
Principal Investigator
Investigator Name
Steven Cohen
Investigator Email
srcohen@montefiore.org
Investigator Phone
917-817-9696
Categories Mesh Debug
COVID-19 --- VIRUS DISEASES
Hepatitis --- VIRUS DISEASES
Infectious Disease --- VIRUS DISEASES
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
MeSH Terms
MOLLUSCUM CONTAGIOSUM
POXVIRIDAE INFECTIONS
DNA VIRUS INFECTIONS
VIRUS DISEASES
INFECTIONS
SKIN DISEASES, VIRAL
SKIN DISEASES, INFECTIOUS
SKIN DISEASES
SKIN AND CONNECTIVE TISSUE DISEASES
CANTHARIDIN
COUNTERFEIT DRUGS
BENZOFURANS
HETEROCYCLIC COMPOUNDS, 2-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING
HETEROCYCLIC COMPOUNDS
SUBSTANDARD DRUGS
PHARMACEUTICAL PREPARATIONS