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New cream could help kids with 'Butterfly Skin' heal faster

NCT ID NCT07482787

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 8 times

Summary

This phase 3 trial tests whether a cream called SD-101 can help close wounds in children with epidermolysis bullosa (EB), a condition that causes fragile, blistering skin. About 80 children aged 1 month to 12 years will apply the cream or a placebo to their whole body for 2 months. The main goal is to see if the cream helps a target wound close completely within one month.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SD-101 (allantoin) cream
What this could lead to
If it works, this could provide a safe, at-home cream to help close wounds faster in children with epidermolysis bullosa.
What could go wrong
This is still a placebo-controlled trial, so it's not yet proven to work. The cream may not be more effective than placebo, and results may not apply to all types of EB.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

28 days to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (intermediate) 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medical University of South Carolina Department of Dermatology and Dermatologic Surgery

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Mission Dermatology

    RECRUITING

    Rancho Santa Margarita, California, 92688, United States

  • Stanford University School of Medicine Dermatology Department

    RECRUITING

    Redwood City, California, 94063, United States

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