An Open Label Extension Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
Starting soon · Phase 3
Conditions studied: Epidermolysis Bullosa (EB)
In brief
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.
Key facts
- Study ID
- NCT07482813
- Run by
- Paradigm Therapeutics
- People needed
- 80
- Starts
- 2026-07-15
- Expected to finish
- 2027-08-19
- Last updated by the study team
- 2026-03-19
Who can join
Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
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.
Full record on ClinicalTrials.gov
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