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| ID | Type | Description | Link |
|---|---|---|---|
| RR000046 | Other Grant/Funding Number | National Center for Research Resources (NCRR) |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
| Doris Duke Charitable Foundation | OTHER |
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The University of North Carolina Department of Dermatology is conducting a clinical trial to evaluate a drug called cantharidin in the treatment of molluscum contagiosum. Molluscum is a common dermatologic disorder caused by a poxvirus. Molluscum typically presents with many flesh-colored bumps on the skin. It goes away on its own, though can last several months to several years. Cantharidin is a topical medicine which is applied at the clinic visit. It is well tolerated by the majority of children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Placebo Comparator | Subjects in this group will have topical application of cantharidin's vehicle at each visit. |
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| II | Experimental | Subjects in this group will have topical application of cantharidin at each visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cantharidin's vehicle | Drug | Cantharidin's vehicle is composed of: Hydroxypropylcellulose, Acetone, and Collodion Flexible. The vehicle will be topically applied to molluscum lesions at each visit. Only two lesions will be treated at the first visit, and up to 20 lesions can be treated at subsequent visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Patients Experiencing Complete Clearance of All Molluscum Lesions. | Baseline compared to 8 weeks (5 visits) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Each Group Measured by Lesion Count. | Average change in number of lesions from baseline to 8 weeks | Baseline compared to 8 weeks (5 visits) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacquelyn R Dosal, MD | UNC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
Participants were excluded if they did not meet inclusion criteria, if they did not have a true diagnosis of molluscum contagiosum, if they were immunosuppressed, or if they had previously been treated with cantharidin.
Patients were recruited from the UNC Dermatology clinics, through practitioners in the surrounding community, and through mass email to the University system (University of Chapel Hill).
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle | Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application. |
| FG001 | Cantharidin | Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle | Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Patients Experiencing Complete Clearance of All Molluscum Lesions. | We used a power calculation to estimate the number of patients needed to detect a clinically significant result. | Posted | Number | Participants | Baseline compared to 8 weeks (5 visits) | Participants | Participants |
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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 | Vehicle | Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain after application of cantharidin or vehicle | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Self-reported pain after application. One patient in the cantharidin group reported pain with removal (with soap and water) of the medication. |
Small sample size and random disproportionate assignment to the vehicle group. Other limitations include short duration of follow up and interval between treatments. Finally, matching subjects in each group with comparable lesion counts.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dean Morrell | University of North Carolina, Chapel Hill | 919-843-5539 | morrell@med.unc.edu |
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| ID | Term |
|---|---|
| D008976 | Molluscum Contagiosum |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Cantharidin 0.7% | Drug | Subjects in this arm will receive cantharidin at all visits. At the first visit, up to 2 lesions can have application with cantharidin. All other visits will have up to 20 lesions with application of the cantharidin. During every visit, lesions will be counted and subjects will be assessed for any adverse events. |
|
| BG001 | Cantharidin | Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Cantharidin |
Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application. |
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| Secondary | Mean Change in Each Group Measured by Lesion Count. | Average change in number of lesions from baseline to 8 weeks | Posted | Mean | Standard Deviation | lesions | Baseline compared to 8 weeks (5 visits) |
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| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | Cantharidin | Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application. | 0 | 13 | 3 | 13 |
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| D017193 |
| Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D017437 | Skin and Connective Tissue Diseases |