Trial Outcomes & Findings for Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum, Phase 2 (NCT NCT03017846)
NCT ID: NCT03017846
Last Updated: 2019-01-30
Results Overview
100% reduction in baseline lesion count
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Assessed at each visit, until final visit on week 12
Results posted on
2019-01-30
Participant Flow
Participant milestones
| Measure |
Cantharidin Treatment
Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.
Cantharidin: Application of topical cantharidin
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Cantharidin Treatment
Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.
Cantharidin: Application of topical cantharidin
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum, Phase 2
Baseline characteristics by cohort
| Measure |
Cantharidin Treatment
n=30 Participants
Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.
Cantharidin: Application of topical cantharidin
|
|---|---|
|
Age, Customized
Age 1-3 years
|
6 Participants
n=39 Participants
|
|
Age, Customized
Age 4-6 years
|
11 Participants
n=39 Participants
|
|
Age, Customized
Age 7-10 years
|
12 Participants
n=39 Participants
|
|
Age, Customized
Age 11-13 years
|
1 Participants
n=39 Participants
|
|
Age, Customized
Age 14-17 years
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
17 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Assessed at each visit, until final visit on week 12100% reduction in baseline lesion count
Outcome measures
| Measure |
Cantharidin Treatment
n=30 Participants
Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.
Cantharidin: Application of topical cantharidin
|
NCT02665260
Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks in the previous study NCT02665260.
Cantharidin: Application of topical cantharidin
|
|---|---|---|
|
Number of Participants With Total Lesion Clearance
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: At study completion, up to 12 weeksOutcome measures
| Measure |
Cantharidin Treatment
n=27 Participants
Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.
Cantharidin: Application of topical cantharidin
|
NCT02665260
Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks in the previous study NCT02665260.
Cantharidin: Application of topical cantharidin
|
|---|---|---|
|
Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions
|
14 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (At beginning of study, before treatment) and end of study (at study completion, week 12 or at earlier visit if all lesions have cleared)Population: All patients who were not lost to follow-up.
Change in the Total Children's Dermatology Life Quality Index (CDLQI) given Visit 1 prior to the first treatment and at the last study visit, up to 12 weeks. The CDLQI examines how the patient feels about the symptoms and treatment, as well as how it affects leisure, school, personal relationships, sleep, clothing choices. A total score is calculated. The total score for the CDLQI scores range: 0-1 = no effect on child's life 2-6 = small effect 7-12 = moderate effect 13-18 = very large effect 19-30 = extremely large effect
Outcome measures
| Measure |
Cantharidin Treatment
n=27 Participants
Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.
Cantharidin: Application of topical cantharidin
|
NCT02665260
Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks in the previous study NCT02665260.
Cantharidin: Application of topical cantharidin
|
|---|---|---|
|
Change in the Total Children's Dermatology Life Quality Index Score
At beginning of study, before treatment
|
3.9 score on a scale
Standard Deviation 5.6
|
—
|
|
Change in the Total Children's Dermatology Life Quality Index Score
At end of study
|
0.38 score on a scale
Standard Deviation 1.3
|
—
|
SECONDARY outcome
Timeframe: At study completion, up to 12 weeksComparison of the number of subjects achieving complete lesion clearance at study completion (up to 12 weeks) to the same measure obtained in our previous study (NCT02665260)
Outcome measures
| Measure |
Cantharidin Treatment
n=25 Participants
Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.
Cantharidin: Application of topical cantharidin
|
NCT02665260
n=23 Participants
Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks in the previous study NCT02665260.
Cantharidin: Application of topical cantharidin
|
|---|---|---|
|
Number of Patients Achieving Complete Lesion Clearance Compared to Prior Study (NCT02665260)
|
11 Participants
|
7 Participants
|
Adverse Events
Cantharidin Treatment
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cantharidin Treatment
n=30 participants at risk
Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.
Cantharidin: Application of topical cantharidin
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Gastrointestinal disorders
Tooth Fracture
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
General disorders
Pain
|
6.7%
2/30 • Number of events 2 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
General disorders
Pyrexia
|
10.0%
3/30 • Number of events 3 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Immune system disorders
Hypersensitivity
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
4/30 • Number of events 4 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Application Site Discoloration
|
40.0%
12/30 • Number of events 12 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Application Site Vesicles
|
70.0%
21/30 • Number of events 21 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.7%
2/30 • Number of events 2 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
6/30 • Number of events 6 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Excoriation
|
6.7%
2/30 • Number of events 2 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Impetigo
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin pain
|
10.0%
3/30 • Number of events 3 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.7%
8/30 • Number of events 8 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
3/30 • Number of events 3 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected through study completion, up to 12 weeks.
|
|
Skin and subcutaneous tissue disorders
Scab
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected through study completion, up to 12 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place