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

March 18, 2026 updated by: Paradigm Therapeutics

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, study to compare the efficacy and safety of SD-101-6.0 cream vs. placebo (SD 101-0.0) on wounds in patients with Simplex, Recessive Dystrophic, or Junctional non-Herlitz (JEB-nH) EB.

SD-101-6.0 cream or placebo (SD-101-0.0) will be applied topically, once a day to the entire body for a period of 60 days. Enrolled patients will have 1 target wound selected at baseline. The selected target wound must be at least 21 days old (size 10 to 50 cm2). Photographic confirmation of the target wound location will be collected at baseline, and the picture saved from the first visit will be used to confirm location of the target wound at subsequent visits. The patient will return to the study site for Visit 2 (14 days ±7 days from baseline), Visit 3 (30 days ±7 days from baseline), and Visit 4 (60 days ±7 days from baseline) to have the target wound re-assessed for the level of healing. Once the target wound is healed, it will be considered healed at subsequent visits and no further re-assessment of the target wound will be conducted The ARANZ SilhouetteStar™ will be used to measure the target wound at all visits until the target wound is documented as closed. Assessment of itching will be evaluated at each visit. In addition, body surface area (BSA), and other secondary endpoints will be evaluated at the baseline and Month 2 visits.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Informed Consent (ICF) form signed by the patient or patient's legal representative. Since all patients with be 12 years old or younger at study entry, signed assent from the patient's legal representative will be required.
  2. Patient (or caretaker) must be willing to comply with all protocol requirements.
  3. Diagnosis of Simplex, Recessive Dystrophic, or JEB-nH EB.
  4. Patient must have 1 target wound (size 10 to 50 cm2).
  5. Patients must be between 28 days to 12 years at study entry
  6. Target wound must be present for 21 days or more.
  7. Patients must have wound burden based on BSA of ≥5% at baseline

Exclusion Criteria:

  1. Patients who do not meet the entry criteria outlined above.
  2. Selected target wound cannot have clinical evidence of local infection.
  3. Use of any investigational drug or approved EB therapy within 30 days before enrollment.
  4. Use of immunotherapy or cytotoxic chemotherapy within 60 days before enrollment.
  5. Use of systemic or topical steroidal therapy within 30 days before enrollment. (Inhaled steroids and ophthalmic drops containing steroids are allowed)
  6. Use of systemic antibiotics within 7 days before enrollment.
  7. Current or former malignancy.

  8. Participant is one of the following:

    1. Not of childbearing potential (premenarchal or male/not in possession of a uterus).

    2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SD-101 Dermal Cream (6%)
Drug: SD-101 Dermal Cream (6%)
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.
Placebo Comparator: Vehicle (SD-101 0%)
Drug: Vehicle (SD-101 0%)
A white, crystalline powder that is formulated within an odorless, soft, white cream base. It contains no allantoin, only excipients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target wound closure
Time Frame: 1 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.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in wound burden
Time Frame: 2 months
Change in wound burden based on BSA measurements at Month 2, compared to Baseline.
2 months
Change in itching
Time Frame: 2 months
The Itch Man Pruritus Assessment Tool, which is a validated 5-point Likert scale that goes from 0 to 4, where 0 is comfortable and 4 is the most terrible. The scale is used to assess itching at Week 1 (Days 1-7), Week 2, Month 1 and Month 2, compared to Baseline.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paradigm Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

May 17, 2027

Study Completion (Estimated)

June 17, 2027

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SD-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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