ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
Public ClinicalTrials.gov record NCT02384460. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients With Epidermolysis Bullosa
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT02384460
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 169 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Month and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 10, 2015
- Primary completion
- Jul 4, 2017
- Completion
- Jul 4, 2017
- Last update posted
- Apr 8, 2020
2015 – 2017
United States locations
- U.S. sites
- 21
- U.S. states
- 17
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Phoenix | Arizona | 85016 | — |
| Not listed | Redwood City | California | 94063 | — |
| Not listed | Aurora | Colorado | 80045 | — |
| Not listed | Washington D.C. | District of Columbia | 20016 | — |
| Not listed | Miami | Florida | 33136 | — |
| Not listed | Miami | Florida | 33155 | — |
| Not listed | Chicago | Illinois | 60611 | — |
| Not listed | Minneapolis | Minnesota | 55455 | — |
| Not listed | Columbia | Missouri | 65212 | — |
| Not listed | St Louis | Missouri | 63110 | — |
| Not listed | Lebanon | New Hampshire | 03756 | — |
| Not listed | Hackensack | New Jersey | 07601 | — |
| Not listed | East Setauket | New York | 11733 | — |
| Not listed | New York | New York | 10032 | — |
| Not listed | Chapel Hill | North Carolina | 27516 | — |
| Not listed | Cincinnati | Ohio | 45229-3039 | — |
| Not listed | Philadelphia | Pennsylvania | 19104 | — |
| Not listed | Charleston | South Carolina | 29425-5780 | — |
| Not listed | Austin | Texas | 78723 | — |
| Not listed | San Antonio | Texas | 78218 | — |
| Not listed | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.
Recently updated Epidermolysis Bullosa trials
Other public records listing Epidermolysis Bullosa. Sorted by last update posted; newest first. Not a recommendation.
- NCT06834035: Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa Recruiting
- NCT05838092: Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III) Active, not recruiting
- NCT05725018: A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients Active, not recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02384460, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 8, 2020 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02384460 live on ClinicalTrials.gov.