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Clinical trials

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Condition / disease
Location
Status: Not yet recruiting

An Open Label Extension Safety Study to Evaluate SD-101 in Epidermolysis Bullosa

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.

Participants needed: 80
Trial details
Phase: Phase 3Age: 28-12Biological sex: AllType: InterventionalSponsor: Paradigm TherapeuticsUpdated: Sep 9, 2026
Eligibility criteria

ICF signed by the subject or subject's legal representative; if the subject is u... [+2]

Subjects who do not meet the entry criteria outlined above. [+5]

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Status: Recruiting

Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa

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).

Participants needed: 80
Trial details
Phase: Phase 3Age: 28-12Biological sex: AllType: InterventionalSponsor: Paradigm TherapeuticsUpdated: Sep 4, 2026Locations: 3
Eligibility criteria

Informed Consent (ICF) form signed by the patient or patient's legal representat... [+6]

Patients who do not meet the entry criteria outlined above. [+10]

Read more