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Phase 2 N=30 Treatment

Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum, Phase 2

Molluscum Contagiosum

Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Number of Participants With Total Lesion Clearance — 11 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Cantharidin (Drug)
Age
Pediatric · 2+ yrs
Sex
All
Sponsor
Steven R Cohen
Primary completion
Sep 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Total Lesion Clearance
11
SECONDARY
Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions
14
SECONDARY
Change in the Total Children's Dermatology Life Quality Index Score
3.9; 0.38
SECONDARY
Number of Patients Achieving Complete Lesion Clearance Compared to Prior Study (NCT02665260)
11; 7

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03017846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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