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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cantharidin with occlusion | Active Comparator | Cantharidin 0.7% topical with occlusion |
|
| Cantharidin without occlusion | Experimental | Cantharidin 0.7% topical without occlusion |
|
| Placebo with occlusion | Placebo Comparator | Placebo topical with occlusion |
|
| Placebo without occlusion | Placebo Comparator | Placebo topical without occlusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cantharidin | Drug | cantharidin 0.7% topical liquid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 33 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 6 subjects met exclusion criteria for having greater than 50 molluscum contagiosum lesions at screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cantharidin With Occlusion | Patients treated with cantharidin 0.7% topical with occlusion |
| FG001 | Cantharidin Without Occlusion | Patients treated with cantharidin 0.7% topical without occlusion |
| FG002 | Placebo With Occlusion | Patients treated with placebo and occlusion |
| FG003 | Placebo Without Occlusion | Patients treated with placebo without conclusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cantharidin | Patients treated with 0.7% topical cantharidin without occlusion |
| BG001 | Cantharidin With Occlusion | Patients treated with 0.7% topical cantharidin with occlusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Count of Participants | Participants | 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cantharidin | Subjects treated with topical cantharidin 0.7% without occlusion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Cohen | Montefiore Medical center | 718-920-8470 | dermpharmeinstein@gmail.com |
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| ID | Term |
|---|---|
| D008976 | Molluscum Contagiosum |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D002193 | Cantharidin |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo topical liquid |
|
|
| Gauze occlusion bandage | Device | Gauze occlusion bandage with adhesive tape |
|
| BG002 | Placebo | Patients treated with placebo without occlusion |
| BG003 | Placebo With Occlusion | Patients treated with placebo vehicle with occlusion |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
Patients treated with placebo and occlusion
| OG003 | Placebo Without Occlusion | Patients treated with placebo without conclusion |
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 33 weeks |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Cantharidin With Occlusion | Subjects treated with topical cantharidin 0.7% with occlusion | 0 | 24 | 0 | 24 |
| EG002 | Placebo | Subjects treated with placebo without occlusion | 0 | 22 | 0 | 22 |
| EG003 | Placebo With Occlusion | Subjects treated with placebo with occlusion | 0 | 25 | 0 | 25 |
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| D017193 |
| Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Number not experiencing adverse event |
|