A Phase 2 interventional study of Cantharidin and Placebo in Molluscum Contagiosum, sponsored by Montefiore Medical Center. Completed. Open to participants aged 2 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-05.
Sponsored by Montefiore Medical Center · Phase 2, Interventional, and Treatment
The purpose of this study is to determine if cantharidin is a safe and effective treatment for molluscum contagiosum in kids
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).
22 studies on the registry are indexed under Molluscum Contagiosum; none are open to participants now.
This study's enrollment of 94 is close to the median of 94 across 19 interventional studies indexed under Molluscum Contagiosum.
Browse Molluscum Contagiosum studies →Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cantharidin 0.7% topical with occlusion
Drug: Cantharidin · Device: Gauze occlusion bandage
Cantharidin 0.7% topical without occlusion
Drug: Cantharidin
Placebo topical with occlusion
Drug: Placebo · Device: Gauze occlusion bandage
Placebo topical without occlusion
Drug: Placebo
cantharidin 0.7% topical liquid
Also known as: 2,6-Dimethyl-4,10-dioxatricyclo-decane-3,5-dione
Placebo topical liquid
Also known as: flexible collodion
Gauze occlusion bandage with adhesive tape
Number of Subjects Who Achieve Complete Clearance at 6 Weeks
Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase)
Time frame: 6 weeks
Number of Subjects Who Experienced an Adverse Event
Number of subjects who experienced an adverse event as assessed by patient-reported outcomes questionnaire at each visit
Time frame: 33 weeks
| Milestone | Cantharidin With Occlusion | Cantharidin Without Occlusion | Placebo With Occlusion | Placebo Without Occlusion |
|---|---|---|---|---|
| Started | 24 | 23 | 25 | 22 |
| Completed | 22 | 22 | 21 | 21 |
| Not completed | 2 | 1 | 4 | 1 |
Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase)
| Participants | Cantharidin With Occlusion | Cantharidin Without Occlusion | Placebo With Occlusion | Placebo Without Occlusion |
|---|---|---|---|---|
| Number of subjects achieving lesion clearance | 10 | 7 | 2 | 3 |
| Number of subjects not achieving lesion clearance | 14 | 16 | 23 | 19 |
Number of subjects who experienced an adverse event as assessed by patient-reported outcomes questionnaire at each visit
| Participants | Cantharidin | Cantharidin With Occlusion | Placebo | Placebo With Occlusion |
|---|---|---|---|---|
| Number experiencing adverse event | 0 | 0 | 0 | 0 |
| Number not experiencing adverse event | 23 | 24 | 22 | 25 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cantharidin | — | 0/23 (0%) | 0/23 (0%) |
| Cantharidin With Occlusion | — | 0/24 (0%) | 0/24 (0%) |
| Placebo | — | 0/22 (0%) | 0/22 (0%) |
| Placebo With Occlusion | — | 0/25 (0%) | 0/25 (0%) |
| Age, Categorical(Participants) | Cantharidin | Cantharidin With Occlusion | Placebo | Placebo With Occlusion | Total |
|---|---|---|---|---|---|
| <=18 years | 23 | 24 | 22 | 25 | 94 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Cantharidin | Cantharidin With Occlusion | Placebo | Placebo With Occlusion | Total |
|---|---|---|---|---|---|
| Female | 14 | 13 | 10 | 15 | 52 |
| Male | 9 | 11 | 12 | 10 | 42 |
| Race/Ethnicity, Customized(participants) | Cantharidin | Cantharidin With Occlusion | Placebo | Placebo With Occlusion | Total |
|---|---|---|---|---|---|
| Hispanic | 22 | 16 | 13 | 17 | 68 |
| African American | 1 | 3 | 3 | 5 | 12 |
| Caucasian | 0 | 4 | 3 | 1 | 8 |
| Asian | 0 | 1 | 3 | 1 | 5 |
| Jamaican | 0 | 0 | 0 | 1 | 1 |
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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