Study of Effectiveness and Safety of SD-101 in Subjects with Epidermolysis Bullosa
Research type
Research Study
Full 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
IRAS ID
159482
Contact name
Anna Martinez
Contact email
Sponsor organisation
Novella Clinical
Eudract number
2014-002288-14
Research summary
An investigation is being conducted to look into how safe and effective the study drug, SD-101, is in patients with Epidermolysis Bullosa.
Epidermolysis Bullosa is an inherited skin fragility disorder which is both debilitating and life threatening. Currently, there is no standard of care therapy for this disease. The study drug is a cream which applied to the skin.
This study will be for Epidermolysis Bullosa patients and those who choose to enrol onto the study will participate for approximately 90 days. During the study, patients will need to attend 5 outpatient visits, complete a medication diary and pain and itching scales and also apply the study drug cream all over their body once per day.
REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/1293
Date of REC Opinion
26 Sep 2014
REC opinion
Further Information Favourable Opinion