Trial Outcomes & Findings for Efficacy of Cantharidin in Molluscum Contagiosum (NCT NCT00667225)

NCT ID: NCT00667225

Last Updated: 2011-06-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: Baseline compared to 8 weeks (5 visits)
• Results posted on: 2011-06-21

Participant Flow

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).

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	16	13
Overall Study COMPLETED	15	12
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	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.	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.
Overall Study Subject had no more lesions to treat.	1	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Efficacy of Cantharidin in Molluscum Contagiosum

Baseline characteristics by cohort

Measure	Vehicle n=16 Participants 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.	Cantharidin n=13 Participants 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.	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	7.3 years STANDARD_DEVIATION 1.7 • n=5 Participants	6.7 years STANDARD_DEVIATION 1.8 • n=7 Participants	7 years STANDARD_DEVIATION 1.3 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	13 participants n=7 Participants	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Vehicle n=16 Participants 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.	Cantharidin n=13 Participants 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.
Patients Experiencing Complete Clearance of All Molluscum Lesions.	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline compared to 8 weeks (5 visits)

Average change in number of lesions from baseline to 8 weeks

Outcome measures

Measure	Vehicle n=16 Participants 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.	Cantharidin n=13 Participants 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.
Mean Change in Each Group Measured by Lesion Count.	26.26 lesions Standard Deviation 27.55	35.61 lesions Standard Deviation 48.15

Adverse Events

Vehicle

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cantharidin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vehicle n=16 participants at risk 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.	Cantharidin n=13 participants at risk 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.
Skin and subcutaneous tissue disorders Pain after application of cantharidin or vehicle	6.2% 1/16 • Number of events 1	23.1% 3/13 • Number of events 3

Additional Information

Dean Morrell

University of North Carolina, Chapel Hill

Phone: 919-843-5539

Email: morrell@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place