Molluscum Contagiosum, Skin Disease
Conditions
Brief summary
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.
Interventions
DRUGcantharidin's vehicle
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.
DRUGCantharidin 0.7%
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.
Sponsors
National Center for Research Resources (NCRR)
Doris Duke Charitable Foundation
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Anyone aged 5-10 years with the clinical diagnosis of molluscum contagiosum.
Exclusion criteria
* Anyone with immunosuppression including HIV or previous organ transplantation. * Anyone taking immunosuppressive medications. * Anyone who has previously received treatment with cantharidin. * Any female who has had her first menstrual period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients Experiencing Complete Clearance of All Molluscum Lesions. | Baseline compared to 8 weeks (5 visits) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Each Group Measured by Lesion Count. | Baseline compared to 8 weeks (5 visits) | Average change in number of lesions from baseline to 8 weeks |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 13 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Subject had no more lesions to treat. | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Vehicle | Cantharidin |
|---|---|---|---|
| Age, Categorical <=18 years | 29 Participants | 16 Participants | 13 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 7 years STANDARD_DEVIATION 1.3 | 7.3 years STANDARD_DEVIATION 1.7 | 6.7 years STANDARD_DEVIATION 1.8 |
| Region of Enrollment United States | 29 participants | 16 participants | 13 participants |
| Sex: Female, Male Female | 18 Participants | 10 Participants | 8 Participants |
| Sex: Female, Male Male | 11 Participants | 6 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 16 | 3 / 13 |
| serious Total, serious adverse events | 0 / 16 | 0 / 13 |
Outcome results
Primary
Patients Experiencing Complete Clearance of All Molluscum Lesions.
Time frame: Baseline compared to 8 weeks (5 visits)
Population: We used a power calculation to estimate the number of patients needed to detect a clinically significant result.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle | Patients Experiencing Complete Clearance of All Molluscum Lesions. | 1 Participants |
| Cantharidin | Patients Experiencing Complete Clearance of All Molluscum Lesions. | 3 Participants |
Secondary
Mean Change in Each Group Measured by Lesion Count.
Average change in number of lesions from baseline to 8 weeks
Time frame: Baseline compared to 8 weeks (5 visits)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Mean Change in Each Group Measured by Lesion Count. | 26.26 lesions | Standard Deviation 27.55 |
| Cantharidin | Mean Change in Each Group Measured by Lesion Count. | 35.61 lesions | Standard Deviation 48.15 |