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.
Brief Title
Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum, Phase 2
Completion Date
Completion Date Type
Actual
Conditions
Molluscum Contagiosum
Eligibility Criteria
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.
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.
Inclusion Criteria
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
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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
17 Years
Minimum Age
2 Years
NCT Id
NCT03017846
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
16-10-195
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Primary Outcomes
Outcome Description
100% reduction in baseline lesion count
Outcome Measure
Number of Participants With Total Lesion Clearance
Outcome Time Frame
Assessed at each visit, until final visit on week 12
Secondary Outcomes
Outcome Time Frame
At study completion, up to 12 weeks
Outcome Measure
Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions
Outcome Description
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
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 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)
Outcome Measure
Change in the Total Children's Dermatology Life Quality Index Score
Outcome Description
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)
Outcome Time Frame
At study completion, up to 12 weeks
Outcome Measure
Number of Patients Achieving Complete Lesion Clearance Compared to Prior Study (NCT02665260)
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
17
Minimum Age Number (converted to Years and rounded down)
2
Investigators
Investigator Type
Principal Investigator
Investigator Name
Steven Cohen
Investigator Email
srcohen@montefiore.org
Investigator Phone
917-817-9696
Categories Mesh Debug
COVID-19 --- VIRUS DISEASES
Hepatitis --- VIRUS DISEASES
Infectious Disease --- VIRUS DISEASES
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
MeSH Terms
MOLLUSCUM CONTAGIOSUM
POXVIRIDAE INFECTIONS
DNA VIRUS INFECTIONS
VIRUS DISEASES
INFECTIONS
SKIN DISEASES, VIRAL
SKIN DISEASES, INFECTIOUS
SKIN DISEASES
SKIN AND CONNECTIVE TISSUE DISEASES
CANTHARIDIN
BENZOFURANS
HETEROCYCLIC COMPOUNDS, 2-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING
HETEROCYCLIC COMPOUNDS