Trial Outcomes & Findings for Safety and Efficacy Study of Topical Cantharidin for the Treatment of Molluscum Contagiosum (NCT NCT02665260)

NCT ID: NCT02665260

Last Updated: 2017-05-05

Results Overview

Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 94 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2017-05-05

Participant Flow

A total of 6 subjects met exclusion criteria for having greater than 50 molluscum contagiosum lesions at screening.

Participant milestones

Measure	Cantharidin With Occlusion Patients treated with cantharidin 0.7% topical with occlusion	Cantharidin Without Occlusion Patients treated with cantharidin 0.7% topical without occlusion	Placebo With Occlusion Patients treated with placebo and occlusion	Placebo Without Occlusion Patients treated with placebo without conclusion
Overall Study STARTED	24	23	25	22
Overall Study COMPLETED	22	22	21	21
Overall Study NOT COMPLETED	2	1	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of Topical Cantharidin for the Treatment of Molluscum Contagiosum

Baseline characteristics by cohort

Measure	Cantharidin n=23 Participants Patients treated with 0.7% topical cantharidin without occlusion	Cantharidin With Occlusion n=24 Participants Patients treated with 0.7% topical cantharidin with occlusion	Placebo n=22 Participants Patients treated with placebo without occlusion	Placebo With Occlusion n=25 Participants Patients treated with placebo vehicle with occlusion	Total n=94 Participants Total of all reporting groups
Age, Categorical <=18 years	23 Participants n=5 Participants	24 Participants n=7 Participants	22 Participants n=5 Participants	25 Participants n=4 Participants	94 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	15 Participants n=4 Participants	52 Participants n=21 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	10 Participants n=4 Participants	42 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic	22 participants n=5 Participants	16 participants n=7 Participants	13 participants n=5 Participants	17 participants n=4 Participants	68 participants n=21 Participants
Race/Ethnicity, Customized African American	1 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	5 participants n=4 Participants	12 participants n=21 Participants
Race/Ethnicity, Customized Caucasian	0 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	1 participants n=4 Participants	8 participants n=21 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	1 participants n=4 Participants	5 participants n=21 Participants
Race/Ethnicity, Customized Jamaican	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants

PRIMARY outcome

Timeframe: 6 weeks

Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase)

Outcome measures

Measure	Cantharidin With Occlusion n=24 Participants Patients treated with cantharidin 0.7% topical with occlusion	Cantharidin Without Occlusion n=23 Participants Patients treated with cantharidin 0.7% topical without occlusion	Placebo With Occlusion n=25 Participants Patients treated with placebo and occlusion	Placebo Without Occlusion n=22 Participants Patients treated with placebo without conclusion
Number of Subjects Who Achieve Complete Clearance at 6 Weeks Number of subjects achieving lesion clearance	10 Participants	7 Participants	2 Participants	3 Participants
Number of Subjects Who Achieve Complete Clearance at 6 Weeks Number of subjects not achieving lesion clearance	14 Participants	16 Participants	23 Participants	19 Participants

SECONDARY outcome

Timeframe: 33 weeks

Number of subjects who experienced an adverse event as assessed by patient-reported outcomes questionnaire at each visit

Outcome measures

Measure	Cantharidin With Occlusion n=23 Participants Patients treated with cantharidin 0.7% topical with occlusion	Cantharidin Without Occlusion n=24 Participants Patients treated with cantharidin 0.7% topical without occlusion	Placebo With Occlusion n=22 Participants Patients treated with placebo and occlusion	Placebo Without Occlusion n=25 Participants Patients treated with placebo without conclusion
Number of Subjects Who Experienced an Adverse Event Number not experiencing adverse event	23 Participants	24 Participants	22 Participants	25 Participants
Number of Subjects Who Experienced an Adverse Event Number experiencing adverse event	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Cantharidin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cantharidin With Occlusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo With Occlusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Steven Cohen

Montefiore Medical center

Phone: 718-920-8470

Email: dermpharmeinstein@gmail.com

Results disclosure agreements

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