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New cream aims to soothe butterfly skin in Late-Stage trial

NCT ID NCT07482813

Symptom relief Sponsor: Paradigm Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This Phase 3 study tests the safety of SD-101 cream (6% allantoin) in 80 people with epidermolysis bullosa, a condition that causes fragile, blistering skin. Participants must have completed a prior study (SD-007). The main goal is to track any side effects over time.

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 cream (6% allantoin)
What this could lead to
If this cream proves safe, it may offer a way to manage skin symptoms in people with epidermolysis bullosa.
What could go wrong
This is an open-label extension focused on safety, not effectiveness. It only includes patients who already completed another study, so results may not apply to everyone.

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.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Oct 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. 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.

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Conditions

The condition(s) this trial relates to.

epidermolysis bullosa epidermolysis bullosa simplex junctional epidermolysis bullosa, non-Herlitz type recessive dystrophic epidermolysis bullosa

As listed by the trial registrant

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

Epidermolysis bullosa (EB)

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.