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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 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.

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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

Conditions Studied

Interventions

  • DRUG 1% sirolimus cream (TD201 1%)

Study Locations (1)

California

  • Stanford University - Stanford

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2014-01
Est. Completion 2015-11
Phase Phase 1

Sponsor

TransDerm

1 total trials

What the Registry Record Tells You About NCT02152007

The ClinicalTrials.gov registry entry for NCT02152007 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 539-participant average among 4 other Pachyonychia Congenita trials with a reported enrollment target (97% lower). The listed sponsor is TransDerm, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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