Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa (NCT07482787)
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
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Mission Dermatology — Rancho Santa Margarita, California
Age range: 28 Days to 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Mission Dermatology — Rancho Santa Margarita, California
📞 Contact the Study Coordinator
Phone: (352) 586-4083
Email: Cure@Kapadi.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Epidermolysis Bullosa (EB)
- Targeting Collagen VII Antibodies in Bullous Diseases Using Efgartigimod IV (VYVGART) — Redwood City, California
- A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study — Cincinnati, Ohio
Explore by condition: All Epidermolysis Bullosa (EB) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.