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NCT01031901 · ClinicalTrials.gov registry record · Phase 1
Topical Rapamycin Therapy to Alleviate Cutaneous Manifestations of Tuberous Sclerosis Complex (TSC) and Neurofibromatosis I (NF1)
A Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT01031901 is a Phase 1 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 52 participants.
The verdict
NCT01031901, a Phase 1 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
This study is a prospective, randomized, double-blind, placebo-controlled evaluation of the safety of a topically applied formulation of rapamycin to cutaneous fibromatous lesions in subjects with Tuberous Sclerosis Complex (TSC) and Neurofibromatosis I (NF1). Subjects will apply either a Polyvinylidene fluoride (PVDF) coating (Skincerity) containing rapamycin or the PVDF coating alone nightly to fibromatous lesions for a duration of six months. The primary goal of this study is to evaluate the safety of the topical product in patients with TSC and NF1. The secondary goal of this study is to evaluate the effectiveness of the topical product for treatment of cutaneous fibromatous lesions.
Interventions
- DRUG Skincerity
- DRUG Skincerity plus sirolimus/rapamycin
- DRUG Skinercity plus sirolimus/rapamycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2009-12 |
| Est. Completion | 2011-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01031901
The ClinicalTrials.gov registry entry for NCT01031901 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Skincerity is the first listed.
NCT01031901 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01031901 about?
NCT01031901 is a clinical study titled "Topical Rapamycin Therapy to Alleviate Cutaneous Manifestations of Tuberous Sclerosis Complex (TSC) and Neurofibromatosis I (NF1)". This study is a prospective, randomized, double-blind, placebo-controlled evaluation of the safety of a topically applied formulation of rapamycin to cutaneous fibromatous lesions in subjects with Tuberous Sclerosis Complex (TSC) and Neurofibromatosis I (NF1). Subjects will apply either a Polyvinyli...
What is the current status of trial NCT01031901?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2009-12. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01031901?
The interventions under investigation include: Skincerity (DRUG), Skincerity plus sirolimus/rapamycin (DRUG), Skinercity plus sirolimus/rapamycin (DRUG).
Who is sponsoring clinical trial NCT01031901?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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