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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 is a Phase 3 study that has completed, run by Scioderm. The registered enrollment target is 169 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02384460
The ClinicalTrials.gov registry entry for NCT02384460 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 169 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Scioderm, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SD-101-6.0 cream is the first listed.
NCT02384460 reports 0 study locations.
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.
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