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NCT01526356 · ClinicalTrials.gov registry record · Phase 2
Topical Rapamycin to Erase Angiofibromas in TSC
A Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 2
- Development phase
- 179
- Enrollment target
NCT01526356: Completed Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
NCT01526356 is a Phase 2 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 179 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01526356, a Phase 2 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 179 participants
- Enrollment target
Study Summary
The study is a multi-center prospective, randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of a topically applied formulation of rapamycin to cutaneous angiofibromas in subjects with Tuberous Sclerosis Complex (TSC). Subjects will apply either the topical vehicle containing rapamycin or the topical vehicle alone nightly to their angiofibromas for six months. The primary goal of this study is to evaluate the efficacy of the topical medication for reduction of cutaneous angiofibromas in patients with TSC. The secondary goal of this study is to confirm the safety of the topical medication.
Primary Outcome
Subject's lesion/s will be digitally photographed before initial application (visit 1), at each study visit (visits 2 through 6), and immediately prior to study termination (visit 7). Following completion of the study, all photographs will be evaluated by two independent dermatologists blinded to both the treatment arm and the stage of treatment. The dermatologists will assess each photograph's appearance using the facial Angiofibroma Grading Scale (AGS), which assesses the forehead, nose, cheek
Interventions
- DRUG Placebo
- DRUG Rapamycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 179 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
What the finished NCT01526356 record still lists
NCT01526356 is an interventional study that assigns participants to a tested intervention. The registered 179 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01526356 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01526356 about?
NCT01526356 is a clinical study titled "Topical Rapamycin to Erase Angiofibromas in TSC". The study is a multi-center prospective, randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of a topically applied formulation of rapamycin to cutaneous angiofibromas in subjects with Tuberous Sclerosis Complex (TSC). Subjects will apply either the topical vehicle con...
What is the current status of trial NCT01526356?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 179 participants. The study started on 2012-05. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01526356?
The interventions under investigation include: Placebo (DRUG), Rapamycin (DRUG).
Who is sponsoring clinical trial NCT01526356?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01526356's enrollment target sits among peer trials
179 391st of 2000 higher than 1,610 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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