Back to search results

SD-101 for Epidermolysis Bullosa (EB)

This study is testing a cream called SD-101 Dermal Cream (6%) for people with Epidermolysis Bullosa (EB). SD-101 contains allantoin, which is a substance that helps with skin healing. Researchers want to see if SD-101 Dermal Cream (6%) is safe and effective at healing wounds compared to a cream with no allantoin (called Vehicle or SD-101 0%). This study is for children aged 28 days to 12 years old who have Simplex, Recessive Dystrophic, or Junctional non-Herlitz (JEB-nH) types of EB. The main goal is to see if a target wound closes within one month. The study plans to enroll 80 participants, but its current status is unclear.

Study design
This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study comparing SD-101 Dermal Cream (6%) to a placebo (SD-101 0%). It plans to enroll 80 participants.
What's involved
You would apply the cream once a day for 60 days. There are 4 site visits over a 2-month period to assess a target wound and itching.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for wound closure is measured at 1 month. Patients completing the study can continue receiving SD-101-6.0 in an open-label extension study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07482787

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

Recruiting
PHASE3Ages 28–12InterventionalTreatment
Paradigm Therapeutics
~80 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:SD-101 Dermal Cream (6%)Vehicle (SD-101 0%)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Target wound closure
Measured over 1 month

Conditions

Epidermolysis Bullosa (EB)

Explore related trials

Epidermolysis Bullosa Dystrophica, Autosomal RecessiveEpidermolysis Bullosa SimplexJunctional Epidermolysis Bullosa

Where it's being run

1 sites across 1 states
California1

Who to contact

Kathleen Watts
[email protected]
352-586-4083
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Exclusion

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.

What this trial measures

  • Target wound closure1 month

    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.