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

March 16, 2026 updated by: Paradigm Therapeutics

An Open Label Extension, Multi-Center Study to Evaluate the Safety of SD 101 Cream in Subjects With 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open label extension, multi-center, study to assess the continued safety of topically applied SD-101 cream containing (6% allantoin) across the entire skin surface in subjects with Simplex, Recessive Dystrophic, or Junctional non-Herlitz (JEB-nH) EB.

SD-101 cream (containing 6% allantoin) will be applied topically, once a day to the entire body for a period of up to 1 year or until approval. Subjects who complete the SD-007 study will roll over into the SD-008 open label extension study. The baseline visit 1 for SD-008 will occur at the time of the final visit for SD-007. The safety evaluation from the SD-007 final visit will provide the baseline safety assessment for the SD-008 study.

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

  • Name: Kathleen Watts
  • Phone Number: +1-352-586-4083
  • Email: Cure@Kapadi.com

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. 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.
  2. Subject (or caretaker) must be willing to comply with all protocol requirements.
  3. Subjects must complete the SD-007 study.

Exclusion Criteria:

  1. Subjects who do not meet the entry criteria outlined above.
  2. 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)

  3. 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring safety of SD-101-6.0
Time Frame: 1 Year
Evaluate the presence of Adverse Events of patients with Epidermolysis Bullosa using SD-101-6.0 Cream
1 Year

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)

July 15, 2026

Primary Completion (Estimated)

July 19, 2027

Study Completion (Estimated)

August 19, 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 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SD-008

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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