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NCT02152007 · ClinicalTrials.gov registry record · Phase 1
Topical Sirolimus for the Treatment of Pachyonychia Congenita (PC)
A Phase 1 study of Pachyonychia Congenita, sponsored by TransDerm.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT02152007: Completed Phase 1 study of Pachyonychia Congenita, sponsored by TransDerm.
NCT02152007 is a Phase 1 study of Pachyonychia Congenita that has completed, run by TransDerm. The registered enrollment target is 15 participants, below the 539-participant average among 4 other Pachyonychia Congenita trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02152007, a Phase 1 study of Pachyonychia Congenita, has completed, sponsored by TransDerm.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
The primary outcome measure for this Phase 1b safety study is evaluation of system absorption through measurement of serum sirolimus trough levels. The limit of detection of the assay was 2.0 ng/mL.
Conditions Studied
Interventions
- DRUG 1% sirolimus cream (TD201 1%)
Study Locations (1)
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-11 |
| Phase | Phase 1 |
What the finished NCT02152007 record still lists
NCT02152007 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 539-participant average among 4 other Pachyonychia Congenita trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Pachyonychia Congenita appearing as the primary indexed condition, and to 1 intervention - of which 1% sirolimus cream (TD201 1%) is the first listed.
NCT02152007 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02152007 about?
NCT02152007 is a clinical study titled "Topical Sirolimus for the Treatment of Pachyonychia Congenita (PC)". 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...
What is the current status of trial NCT02152007?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2014-01. Estimated completion is 2015-11.
What conditions does trial NCT02152007 study?
This clinical trial studies the following conditions: Pachyonychia Congenita.
What interventions are being tested in trial NCT02152007?
The interventions under investigation include: 1% sirolimus cream (TD201 1%) (DRUG).
Who is sponsoring clinical trial NCT02152007?
This trial is sponsored by TransDerm, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02152007 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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