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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title:

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.

Detailed Summary:
Sponsor: Montefiore Medical Center

Current Primary Outcome: Total lesion clearance [ Time Frame: At week 6 and week 12 of study ]

100% reduction in baseline lesion count


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of subjects who achieve a clearance of at least 90% of their molluscum lesions [ Time Frame: At week 6 and week 12 of study ]
  • Change in the Children's Dermatology Life Quality Index Score [ Time Frame: At week 12 ]
    Change in the Children's Dermatology Life Quality Index (CDLQI) given Visit 1 prior to the first treatment and on Visit 5
  • Comparison to efficacy of previous trial [ Time Frame: At week 6 and week 12 of study ]
    Comparison to the efficacy data obtained in our previous study (NCT02665260) after 2 treatments


Original Secondary Outcome: Same as current

Information By: Montefiore Medical Center

Dates:
Date Received: January 9, 2017
Date Started: September 2016
Date Completion:
Last Updated: January 9, 2017
Last Verified: January 2017