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Topical Sirolimus for the Treatment of Pachyonychia Congenita (PC)

NCT02152007 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-10-07

Study results available
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Summary

A study to evaluate safety and efficacy of topical sirolimus to treat plantar keratoderma in adults with PC. Subjects may receive either placebo or treatment with at least 1 foot receiving topical sirolimus at some time. For certain phases of the study treatment assignment to the right and left foot will be randomized in a double blind fashion. Blood levels will test systemic absorption of sirolimus. Other safety and efficacy measures will be taken through the 39-week study duration. Funding Source - FDA OOPD

Conditions

  • Pachyonychia Congenita

Interventions

DRUG

1% sirolimus cream (TD201 1%)

1% sirolimus cream (TD201 1%)

Sponsors & Collaborators

  • Pachyonychia Congenita Project

    collaborator OTHER

  • TransDerm, Inc.

    lead INDUSTRY

Principal Investigators

  • Roger L Kaspar, PhD · TransDerm, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-07-31
Completion
2015-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02152007 on ClinicalTrials.gov