Epidermolysis Bullosa (EB)Phase 3NCT07482787
Efficacy and 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 at 4 sites in United States.
Trial summary
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. 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?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Jul 2026to 17 Jun 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
- 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.
- Patient (or caretaker) must be willing to comply with all protocol requirements.
- Diagnosis of Simplex, Recessive Dystrophic, or JEB-nH (intermediate) EB.
- Patient must have 1 target wound (size 10 to 50 cm2).
- Patients must be between 28 days to 12 years at study entry
- Target wound must be present for 21 days or more.
- Patients must have wound burden based on BSA of ≥5% at baseline
Who cannot join
- Patients who do not meet the entry criteria outlined above.
- Selected target wound cannot have clinical evidence of local infection.
- Use of any investigational drug or approved EB therapy within 30 days before enrollment.
- Use of immunotherapy or cytotoxic chemotherapy within 60 days before enrollment.
- Use of systemic or topical steroidal therapy within 30 days before enrollment. (Inhaled steroids and ophthalmic drops containing steroids are allowed)
- Use of systemic antibiotics within 7 days before enrollment.
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- Current or former malignancy.
- 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
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Medical University of South Carolina Department of Dermatology and Dermatologic Surgery
Charleston, South Carolina, 29425
Kennedy McLeod, PharmD, 843-792-4091 ext. 107, mcleodke@musc.edu
Wine Lee, MD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Griffin Stockton Hogrogian, 215-590-1930, STOCKTONHG@chop.edu
Marissa Perman, MD
- Recruiting
Mission Dermatology
Rancho Santa Margarita, California, 92688
Andrew Sparacino, PharmD, +1 949-858-3376 ext. 107, asparacino@missiondermatology.com
Shireen Guide, MD
- Recruiting
Stanford University School of Medicine Dermatology Department
Redwood City, California, 94063
Jenny Deng, 650-460-4390, jdeng4@stanford.edu
Jean Tang, MD
About this study
Official title: A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients With Epidermolysis Bullosa
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).
Read the detailed description
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.
- Conditions
- Epidermolysis Bullosa (EB)
- Being tested
- SD-101 Dermal Cream (6%), Vehicle (SD-101 0%)
- Keywords
- Wound closure, Itching, Wound burden
- Medical subject headings
- Epidermolysis Bullosa, Pruritus
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.
Vehicle (SD-101 0%)Drug
A white, crystalline powder that is formulated within an odorless, soft, white cream base. It contains no allantoin, only excipients.
| Study group | Role | What they receive |
|---|---|---|
| SD-101 Dermal Cream (6%) | Active comparator | Not described Receives: Drug: SD-101 Dermal Cream (6%) |
| Vehicle (SD-101 0%) | Placebo comparator | Not described Receives: Drug: Vehicle (SD-101 0%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (2)
Change in wound burden
Change in wound burden based on BSA measurements at Month 2, compared to Baseline.
Measured: 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.
Measured: 2 months
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 start21 Jul 2026
- Primary completion17 May 2027 (estimated)
- Study completion17 Jun 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT07482787
- Sponsor's protocol ID
- SD-007
- Status last verified
- Oct 2026
- First submitted
- 4 Mar 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients With Epidermolysis Bullosa
- ClinicalTrials.gov ID
- NCT07482787
- Acronym / sponsor ID
- SD-007
- Conditions
- Epidermolysis Bullosa (EB)
- Keywords
- Wound closure, Itching, Wound burden
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Paradigm TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- 17 May 2027 (estimated)
- Study completion
- 17 Jun 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 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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SD-101 Dermal Cream (6%) | Active comparator | Drug: SD-101 Dermal Cream (6%) |
| Vehicle (SD-101 0%) | Placebo comparator | Drug: Vehicle (SD-101 0%) |
Who may qualify
- Ages
- 28 days to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
- Patient (or caretaker) must be willing to comply with all protocol requirements.
- Diagnosis of Simplex, Recessive Dystrophic, or JEB-nH (intermediate) EB.
- Patient must have 1 target wound (size 10 to 50 cm2).
- Patients must be between 28 days to 12 years at study entry
Key exclusion criteria (13 listed)
- Patients who do not meet the entry criteria outlined above.
- Selected target wound cannot have clinical evidence of local infection.
- Use of any investigational drug or approved EB therapy within 30 days before enrollment.
- Use of immunotherapy or cytotoxic chemotherapy within 60 days before enrollment.
- Use of systemic or topical steroidal therapy within 30 days before enrollment. (Inhaled steroids and ophthalmic drops containing steroids are allowed)
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%) |
| Vehicle (SD-101 0%)A white, crystalline powder that is formulated within an odorless, soft, white cream base. It contains no allantoin, only excipients. | Drug | Vehicle (SD-101 0%) |
Primary outcome
Target wound closure
Time frame: 1 month
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.
2 secondary outcomes
Change in wound burden
Time frame: 2 months
Change in itching
Time frame: 2 months
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 15 Oct 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.
4 sites in 1 country: see every site and its status.
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 at 4 sites in United States.
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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 (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?
Target wound closure (time frame: 1 month). 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 15 Oct 2026.