An Open Label Extension Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
An Open Label Extension, Multi-Center Study to Evaluate the Safety of SD 101 Cream in Subjects With Epidermolysis Bullosa
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
The objective is to characterize the continued safety of SD-101 cream containing 6% allantoin in the treatment of the skin in patients with Simplex, Recessive Dystrophic, or JEB-nH EB.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2026
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2026
CompletedFirst Posted
Study publicly available on registry
March 19, 2026
CompletedStudy Start
First participant enrolled
July 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 19, 2027
March 19, 2026
March 1, 2026
1 year
March 4, 2026
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Measuring safety of SD-101-6.0
Evaluate the presence of Adverse Events of patients with Epidermolysis Bullosa using SD-101-6.0 Cream
1 Year
Study Arms (1)
SD-101 Dermal Cream (6%)
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- ICF signed by the subject or subject's legal representative; if the subject is under the age of 18 but capable of providing assent, signed assent from the subject.
- Subject (or caretaker) must be willing to comply with all protocol requirements.
- Subjects must complete the SD-007 study.
You may not qualify if:
- Subjects who do not meet the entry criteria outlined above.
- Pregnancy or breastfeeding during the study. (A urine pregnancy test will be performed at the final visit for SD-007 for female subjects of childbearing potential as assessed if needed by the investigator)
- Participant is one of the following:
- Not of childbearing potential (premenarchal or male/not in possession of a uterus).
- If of childbearing potential, is nonpregnant (negative urine pregnancy test results at Screening), nonlactating, and practicing 1 of the following medically acceptable methods of birth control:
- Abstinence from heterosexual intercourse as a lifestyle choice.
- Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the participant's usual menstrual cycle period) before product administration.
- Intrauterine device. If male, is willing to use a highly effective method of contraception throughout the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2026
First Posted
March 19, 2026
Study Start
July 15, 2026
Primary Completion (Estimated)
July 19, 2027
Study Completion (Estimated)
August 19, 2027
Last Updated
March 19, 2026
Record last verified: 2026-03