Molluscum Contagiosum
Conditions
Brief summary
Cantharidin is cited in the dermatology and pediatric literature as a valuable treatment option. Treatment is often available in private practice offices, where a prescribing physician may offer a non-FDA approved treatment on an individualized basis. The situation is different in many hospital and academic settings, such as our own for example, where the formulary is defined through a FDA-approved indication. The absence of an indication precludes its addition to many hospital formularies, thus limiting the options available to a prescribing physician and denying patient access to a treatment offered in the private practice setting. An indication and formulary status require controlled clinical trials on the safety and efficacy of cantharidin in MC. The objective of this trial is to see if this commercially-viable cantharidin formulation has a comparable safety and efficacy profile as formulations previously studied under conditions which most closely match the what has been historically done in the clinic.
Interventions
DRUGCantharidin
Application of topical cantharidin
Sponsors
Steven R Cohen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Diagnosis of MC by the Principal Investigator. Maximum of 50 lesions on locations including the face, trunk, back, left or right arm, left or right leg, hands, feet, buttocks, and groin. Execution of Informed Consent and or assent forms
Exclusion criteria
Patients with immunosuppression, including organ transplantation, HIV infection. Patients utilizing immunosuppressive agents (including oral corticosteroids) will be excluded except for patients using inhaled corticosteroids, such as those utilized for asthma or allergic rhinitis. Females who have reached menarche and are sexually active as well as pregnant patients will be excluded as the effects of this drug have not been evaluated in pregnancy. Patients who have greater than 50 MC lesions will also be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Total Lesion Clearance | Assessed at each visit, until final visit on week 12 | 100% reduction in baseline lesion count |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions | At study completion, up to 12 weeks | — |
| Change in the Total Children's Dermatology Life Quality Index Score | 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) | 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 |
| Number of Patients Achieving Complete Lesion Clearance Compared to Prior Study (NCT02665260) | At study completion, up to 12 weeks | Comparison 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cantharidin Treatment Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.
Cantharidin: Application of topical cantharidin | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Cantharidin Treatment |
|---|---|
| Age, Customized Age 11-13 years | 1 Participants |
| Age, Customized Age 1-3 years | 6 Participants |
| Age, Customized Age 14-17 years | 0 Participants |
| Age, Customized Age 4-6 years | 11 Participants |
| Age, Customized Age 7-10 years | 12 Participants |
| Race/Ethnicity, Customized African American | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 17 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants |
| Race/Ethnicity, Customized Other | 9 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 28 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Number of Participants With Total Lesion Clearance
100% reduction in baseline lesion count
Time frame: Assessed at each visit, until final visit on week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cantharidin Treatment | Number of Participants With Total Lesion Clearance | 11 Participants |
Secondary
Change in the Total Children's Dermatology Life Quality Index Score
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
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cantharidin Treatment | 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 |
| Cantharidin Treatment | 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
Number of Patients Achieving Complete Lesion Clearance Compared to Prior Study (NCT02665260)
Comparison 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)
Time frame: At study completion, up to 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cantharidin Treatment | Number of Patients Achieving Complete Lesion Clearance Compared to Prior Study (NCT02665260) | 11 Participants |
| NCT02665260 | Number of Patients Achieving Complete Lesion Clearance Compared to Prior Study (NCT02665260) | 7 Participants |
Secondary
Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions
Time frame: At study completion, up to 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cantharidin Treatment | Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions | 14 Participants |