Epidermolysis Bullosa (EB)Phase 3NCT07482813
An Open Label Extension Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
A Phase 3 study testing SD-101 Dermal Cream (6%) in people with Epidermolysis Bullosa (EB), run by Paradigm Therapeutics.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 28 days to 12 years
- Conditions the study is for
- Epidermolysis Bullosa (EB)
- What is being tested?
- SD-101 Dermal Cream (6%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 19 Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- Subject (or caretaker) must be willing to comply with all protocol requirements.
- Subjects must complete the SD-007 study.
Who cannot join
- Subjects who do not meet the entry criteria outlined above.
- 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)
- Participant is one of the following:
- Not of childbearing potential (premenarchal or male/not in possession of a uterus).
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Epidermolysis Bullosa (EB)
- Being tested
- SD-101 Dermal Cream (6%)
- Medical subject headings
- Epidermolysis Bullosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SD-101 Dermal Cream (6%)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| SD-101 Dermal Cream (6%) | Active comparator | Not described Receives: Drug: SD-101 Dermal Cream (6%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring safety of SD-101-6.0
Evaluate the presence of Adverse Events of patients with Epidermolysis Bullosa using SD-101-6.0 Cream
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start15 Nov 2026 (estimated)
- Primary completion19 Sep 2027 (estimated)
- Study completion19 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermolysis Bullosa (EB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paradigm Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482813
- Sponsor's protocol ID
- SD-008
- Status last verified
- Sep 2026
- First submitted
- 4 Mar 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Extension, Multi-Center Study to Evaluate the Safety of SD 101 Cream in Subjects With Epidermolysis Bullosa
- ClinicalTrials.gov ID
- NCT07482813
- Acronym / sponsor ID
- SD-008
- Conditions
- Epidermolysis Bullosa (EB)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Paradigm TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 19 Sep 2027 (estimated)
- Study completion
- 19 Oct 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SD-101 Dermal Cream (6%) | Active comparator | Drug: SD-101 Dermal Cream (6%) |
Who may qualify
- Ages
- 28 days to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
- Subject (or caretaker) must be willing to comply with all protocol requirements.
- Subjects must complete the SD-007 study.
Key exclusion criteria (8 listed)
- Subjects who do not meet the entry criteria outlined above.
- 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)
- Participant is one of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | SD-101 Dermal Cream (6%) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Paradigm Therapeutics WebsiteLink provided by the sponsor.
- EB Research Partnership WebsiteLink provided by the sponsor.
- Debra US WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SD-101 Dermal Cream (6%) in people with Epidermolysis Bullosa (EB), run by Paradigm Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Watts (+1-352-586-4083, Cure@Kapadi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring safety of SD-101-6.0 (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.