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NCT02384460 · ClinicalTrials.gov registry record · Phase 3
ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
A Phase 3 study, sponsored by Scioderm.
- Completed
- Registry status
- Phase 3
- Development phase
- 169
- Enrollment target
NCT02384460: Completed Phase 3 study, sponsored by Scioderm.
NCT02384460 is a Phase 3 study that has completed, run by Scioderm. The registered enrollment target is 169 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02384460, a Phase 3 study, has completed, sponsored by Scioderm.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 169 participants
- Enrollment target
Study Summary
The aim was to assess the efficacy and safety of SD-101-6.0 cream versus Placebo (SD-101-0.0) cream in the treatment of skin lesions in participants with Epidermolysis Bullosa. Funding Source - United States Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD).
Primary Outcome
Target wounds were monitored at each study visit for complete closure, defined as skin re-epithelialization without drainage. Time to target wound closure was measured from the date of the first administration of the study drug to the date of target wound closure. Participants were censored if they did not have a response within 3 months, or withdrew earlier before the confirmation of their target wound closing. This primary end point displays the mean time to complete target wound closure, anal
Interventions
- DRUG SD-101-6.0 cream
- DRUG Placebo (SD-101-0.0) cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2015-03-11 |
| Est. Completion | 2017-07-05 |
| Phase | Phase 3 |
What the finished NCT02384460 record still lists
NCT02384460 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which SD-101-6.0 cream is the first listed.
NCT02384460 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02384460 about?
NCT02384460 is a clinical study titled "ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa". The aim was to assess the efficacy and safety of SD-101-6.0 cream versus Placebo (SD-101-0.0) cream in the treatment of skin lesions in participants with Epidermolysis Bullosa. Funding Source - United States Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD).
What is the current status of trial NCT02384460?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 169 participants. The study started on 2015-03-11. Estimated completion is 2017-07-05.
What interventions are being tested in trial NCT02384460?
The interventions under investigation include: SD-101-6.0 cream (DRUG), Placebo (SD-101-0.0) cream (DRUG).
Who is sponsoring clinical trial NCT02384460?
This trial is sponsored by Scioderm, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02384460's enrollment target sits among peer trials
169 1459th of 2000 higher than 542 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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