A Phase 3 interventional study of SD-101 Dermal Cream (6%) and Vehicle (SD-101 0%) in Epidermolysis Bullosa (EB), sponsored by Paradigm Therapeutics. Recruiting at 4 sites in United States. Open to participants aged 28 Days to 12 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Paradigm Therapeutics · Phase 3, Interventional, and Treatment
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).
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.
85 studies on the registry are indexed under Epidermolysis Bullosa; 17 are open to participants now.
This study's planned enrollment of 80 is above the median of 14 across 67 interventional studies indexed under Epidermolysis Bullosa.
Browse Epidermolysis Bullosa studies →Paradigm Therapeutics is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Participant is one of the following:
If of childbearing potential, is nonpregnant (negative urine pregnancy test results at Screening), nonlactating, and practicing 1 of the following medically acceptable methods of :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SD-101 Dermal Cream (6%)
Drug: Vehicle (SD-101 0%)
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.
A white, crystalline powder that is formulated within an odorless, soft, white cream base. It contains no allantoin, only excipients.
Target wound closure
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.
Time frame: 1 month
Change in wound burden
Change in wound burden based on BSA measurements at Month 2, compared to Baseline.
Time frame: 2 months
Change in itching
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.
Time frame: 2 months
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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