Molluscum Contagiosum
Conditions
Brief summary
The purpose of this study is to determine if cantharidin is a safe and effective treatment for molluscum contagiosum in kids
Detailed description
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).
Interventions
DRUGCantharidin
cantharidin 0.7% topical liquid
DRUGPlacebo
Placebo topical liquid
DEVICEGauze occlusion bandage
Gauze occlusion bandage with adhesive tape
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* 2-17years * Healthy * \<50 molluscum contagiosum lesions
Exclusion criteria
* Immunosuppressed * Oral corticosteroids * Sexually active/pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Achieve Complete Clearance at 6 Weeks | 6 weeks | Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Experienced an Adverse Event | 33 weeks | Number of subjects who experienced an adverse event as assessed by patient-reported outcomes questionnaire at each visit |
Participant flow
Pre-assignment details
A total of 6 subjects met exclusion criteria for having greater than 50 molluscum contagiosum lesions at screening.
Participants by arm
| Arm | Count |
|---|---|
| Cantharidin Patients treated with 0.7% topical cantharidin without occlusion | 23 |
| Cantharidin With Occlusion Patients treated with 0.7% topical cantharidin with occlusion | 24 |
| Placebo Patients treated with placebo without occlusion | 22 |
| Placebo With Occlusion Patients treated with placebo vehicle with occlusion | 25 |
| Total | 94 |
Baseline characteristics
| Characteristic | Cantharidin | Cantharidin With Occlusion | Placebo | Placebo With Occlusion | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 23 Participants | 24 Participants | 22 Participants | 25 Participants | 94 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized African American | 1 participants | 3 participants | 3 participants | 5 participants | 12 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 3 participants | 1 participants | 5 participants |
| Race/Ethnicity, Customized Caucasian | 0 participants | 4 participants | 3 participants | 1 participants | 8 participants |
| Race/Ethnicity, Customized Hispanic | 22 participants | 16 participants | 13 participants | 17 participants | 68 participants |
| Race/Ethnicity, Customized Jamaican | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 10 Participants | 15 Participants | 52 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 12 Participants | 10 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 24 | 0 / 22 | 0 / 25 |
| serious Total, serious adverse events | 0 / 23 | 0 / 24 | 0 / 22 | 0 / 25 |
Outcome results
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)
Time frame: 6 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cantharidin With Occlusion | Number of Subjects Who Achieve Complete Clearance at 6 Weeks | Number of subjects achieving lesion clearance | 10 Participants |
| Cantharidin With Occlusion | Number of Subjects Who Achieve Complete Clearance at 6 Weeks | Number of subjects not achieving lesion clearance | 14 Participants |
| Cantharidin Without Occlusion | Number of Subjects Who Achieve Complete Clearance at 6 Weeks | Number of subjects not achieving lesion clearance | 16 Participants |
| Cantharidin Without Occlusion | Number of Subjects Who Achieve Complete Clearance at 6 Weeks | Number of subjects achieving lesion clearance | 7 Participants |
| Placebo With Occlusion | Number of Subjects Who Achieve Complete Clearance at 6 Weeks | Number of subjects achieving lesion clearance | 2 Participants |
| Placebo With Occlusion | Number of Subjects Who Achieve Complete Clearance at 6 Weeks | Number of subjects not achieving lesion clearance | 23 Participants |
| Placebo Without Occlusion | Number of Subjects Who Achieve Complete Clearance at 6 Weeks | Number of subjects achieving lesion clearance | 3 Participants |
| Placebo Without Occlusion | Number of Subjects Who Achieve Complete Clearance at 6 Weeks | Number of subjects not achieving lesion clearance | 19 Participants |
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
Time frame: 33 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cantharidin With Occlusion | Number of Subjects Who Experienced an Adverse Event | Number experiencing adverse event | 0 Participants |
| Cantharidin With Occlusion | Number of Subjects Who Experienced an Adverse Event | Number not experiencing adverse event | 23 Participants |
| Cantharidin Without Occlusion | Number of Subjects Who Experienced an Adverse Event | Number not experiencing adverse event | 24 Participants |
| Cantharidin Without Occlusion | Number of Subjects Who Experienced an Adverse Event | Number experiencing adverse event | 0 Participants |
| Placebo With Occlusion | Number of Subjects Who Experienced an Adverse Event | Number experiencing adverse event | 0 Participants |
| Placebo With Occlusion | Number of Subjects Who Experienced an Adverse Event | Number not experiencing adverse event | 22 Participants |
| Placebo Without Occlusion | Number of Subjects Who Experienced an Adverse Event | Number experiencing adverse event | 0 Participants |
| Placebo Without Occlusion | Number of Subjects Who Experienced an Adverse Event | Number not experiencing adverse event | 25 Participants |