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NCT01853423 · ClinicalTrials.gov registry record · Phase 1
Tuberous Sclerosis Complex: Facial Angiofibroma Skin Cream
A Phase 1 study, sponsored by Le Bonheur Children's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT01853423: Completed Phase 1 study, sponsored by Le Bonheur Children's Hospital.
NCT01853423 is a Phase 1 study that has completed, run by Le Bonheur Children's Hospital. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01853423, a Phase 1 study, has completed, sponsored by Le Bonheur Children's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety and efficacy of a 0.1% formulation of rapamune cream in children with Tuberous Sclerosis Complex (TSC), ages 3 years and older, who have facial angiofibromas that would benefit from treatment.
Primary Outcome
1. Tolerability: Number of participants with adverse events 2. Efficacy: Skin assessment to measure improvement of facial angiofibromas 3. Safety: Rapamune levels (serum)
Interventions
- DRUG Rapamune
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
What the finished NCT01853423 record still lists
NCT01853423 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Rapamune is the first listed.
NCT01853423 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01853423 about?
NCT01853423 is a clinical study titled "Tuberous Sclerosis Complex: Facial Angiofibroma Skin Cream". The objective of this study is to evaluate the safety and efficacy of a 0.1% formulation of rapamune cream in children with Tuberous Sclerosis Complex (TSC), ages 3 years and older, who have facial angiofibromas that would benefit from treatment.
What is the current status of trial NCT01853423?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2013-10. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01853423?
The interventions under investigation include: Rapamune (DRUG).
Who is sponsoring clinical trial NCT01853423?
This trial is sponsored by Le Bonheur Children's Hospital, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01853423's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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