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Tests treatment safety and results for Epidermolysis Bullosa (EB)
Official title Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
ClinicalTrials.gov ID: NCT07482787
What this study is testing
What is SD-101 Dermal Cream (6%)?
SD-101 Dermal Cream (6%) is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for epidermolysis bullosa (eb).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 28 to 12
You may be able to join if
- 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...
- Patient (or caretaker) must be willing to comply with all protocol requirements.
- Diagnosis of Simplex, Recessive Dystrophic, or JEB-nH EB.
- Patient must have 1 target wound (size 10 to 50 cm2).
- Patients must be between 28 days to 12 years at study entry
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- Patient (or caretaker) must be willing to comply with all protocol requirements.
- Diagnosis of Simplex, Recessive Dystrophic, or JEB-nH 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
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rancho Santa Margarita, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 28 days to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rancho Santa Margarita, California, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.