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NCT02960997 · ClinicalTrials.gov registry record · Phase 2
Using Topical Sirolimus 2% for Patients With Epidermolysis Bullous Simplex (EBS) Study
A Phase 2 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT02960997: Completed Phase 2 study, sponsored by Stanford University.
NCT02960997 is a Phase 2 study that has completed, run by Stanford University. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02960997, a Phase 2 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
Epidermolysis bullosa (EB) simplex is a rare orphan disease caused by a mutation in DNA leading to abnormal dominant keratins in the skin. Patients with EB simplex develop lifelong painful thick soles on their feet, and current standard of care is supportive. This pilot study will target the dominant mutant keratin proteins in the skin to ameliorate the severity of EB simplex. The purpose is to improve the function of EB simplex feet with an application of topical sirolimus, 2%. The investigators plan on inhibiting the mTOR pathway to down regulate the translation of defective keratin proteins and work through anti proliferative pathways.
Primary Outcome
Foot function was assessed utilizing the validated Foot Health Status Questionnaire (FHSQ). Low Score (0) means severely limited in performing a broad range of physical activities. High Score (100) means can perform all desired physical activities. Data are reported per intervention.
Interventions
- DRUG Vehicle
- DRUG Sirolimus, 2%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2016-05 |
| Est. Completion | 2021-12-01 |
| Phase | Phase 2 |
What the finished NCT02960997 record still lists
NCT02960997 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT02960997 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02960997 about?
NCT02960997 is a clinical study titled "Using Topical Sirolimus 2% for Patients With Epidermolysis Bullous Simplex (EBS) Study". Epidermolysis bullosa (EB) simplex is a rare orphan disease caused by a mutation in DNA leading to abnormal dominant keratins in the skin. Patients with EB simplex develop lifelong painful thick soles on their feet, and current standard of care is supportive. This pilot study will target the dominan...
What is the current status of trial NCT02960997?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2016-05. Estimated completion is 2021-12-01.
What interventions are being tested in trial NCT02960997?
The interventions under investigation include: Vehicle (DRUG), Sirolimus, 2% (DRUG).
Who is sponsoring clinical trial NCT02960997?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02960997's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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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