Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
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
Sponsor study identifier
interventional
80
1 country
4
Study Start
July 21, 2026
Actual (reported)Primary Completion
May 17, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 17, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The upcoming trial is for EB patients is a topically applied whole-body treatment of patients with either Simplex, RDEB or Junctional (nH) ages 1 month to 12 years old at study entry. There are only 4 site visits by patients with minimal assessments over a 2-month period, and patients completing this study will have the ability to continue receiving SD-101-6.0 at home in an open-label extension study. The drug product and placebo require no special preparation or storage conditions (room temperature).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 17, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 4, 2026
Actual (reported)March 19, 2026
Actual (reported)July 21, 2026
Actual (reported)May 17, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 17, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Target wound closure
The primary endpoint is the proportion of patients in each treatment group who experience complete closure of their target wound by Month 1 on study. Complete target wound closure is defined as skin re-epithelialization without drainage.
1 month
Change in wound burden
2 months
Change in itching
2 months
SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients.
A white, crystalline powder that is formulated within an odorless, soft, white cream base. It contains no allantoin, only excipients.
Mission Dermatology
Rancho Santa Margarita, California, 92688, United States
Stanford University School of Medicine Dermatology Department
Redwood City, California, 94063, United States
First Submitted
March 4, 2026
First Posted
March 19, 2026
Study Start
July 21, 2026
Actual (reported)Primary Completion
May 17, 2027
EstimatedRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina Department of Dermatology and Dermatologic Surgery
Charleston, South Carolina, 29425, United States
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 17, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 15, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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