Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa

Conditions

• Epidermolysis Bullosa (EB)

Eligibility Criteria

Sex

ALL

Age

28 Days - 12 Years

Healthy Volunteers

Not accepted

Interventions

• 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 Details

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).

Key Dates

First listed

Mar 19, 2026

Start date

Jul 21, 2026

Status verified

Jul 2026

Primary completion

May 17, 2027

Completion

Jun 17, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: SD-101 Dermal Cream (6%)
• Placebo Comparator: Vehicle (SD-101 0%)

Primary Outcome Measure

Target wound closure [ Time Frame: 1 month ]

Central Contacts

• Kathleen Watts
  352-586-4083
  [email protected]
• Robert P Ryan, PhD
  919-274-0703
  [email protected]

Locations (1)

Find similar trials in Rancho Santa Margarita, CA

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