CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
SD-101 dermal cream (3%) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02014376
NCT02014376Phase 2Completed
CompareCT.gov

A Phase 2b, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study of the Effectiveness and Safety of SD-101 Cream in Subjects With Epidermolysis Bullosa

Scioderm, Inc.·interventional·Posted Dec 18, 2013·Updated Jan 13, 2020

In Brief

A Phase 2 clinical trial evaluating SD-101 dermal cream (3%), SD-101 Dermal Cream (6%), and 1 other intervention for Epidermolysis Bullosa. Completed, enrolled 48 participants across 7 sites.

Detailed Summary

The purpose of this study was to assess whether the topical use of SD-101 cream (3% or 6%) was effective in treating wounds in participants with Simplex, Recessive Dystrophic, or Junctional non-Herlitz Epidermolysis Bullosa (EB).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpidermolysis Bullosa
CountriesUnited States
CollaboratorsAmicus Therapeutics

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 18, 2013
Enrollment StartJan 6, 2014
Primary CompletionJun 24, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.5 years ago

Interventions

SD-101 dermal cream (3%)drug

SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-3.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 3% and other excipients.

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.