CastleCreek - Diacerein Ointment - CCP-020-301
Research type
Research Study
Full title
An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)
IRAS ID
222887
Contact name
Jemima Mellerio
Contact email
Sponsor organisation
Castle Creek Pharmaceuticals, LLC
Eudract number
2016-004427-24
Clinicaltrials.gov Identifier
131, 384, IND Number
Duration of Study in the UK
0 years, 10 months, 3 days
Research summary
The study drug, Diacerein 1% Ointment is an investigational product being studied in the treatment of epidermolysis bullosa simplex (EBS).
The study is being done to look at:
• How well diacerein ointment works for the treatment of participants with EBS;
• How safe and effective diacerein ointment is as compared to a placebo ointment.Diacerein in the topical formulation is broken down into "rhein" within the skin which is then absorbed into the blood stream. Rhein has shown to reduce the production of inflammatory proteins, which it does this in a way different to current non-steroid based drugs. This means it could be beneficial to those with EBS for whom current medication is not working.
Up to 80 patients with EBS (of at least 4 years of age) in the US, Europe, Israel, and Australia will be recruited to take part in this study. Eligible patients will have a 50/50 chance of receiving the study drug or placebo. Patients will take part in this study and undergo tests for up to 22 weeks (up to 6 weeks screening, 8 weeks treatment and 8 weeks post-treatment follow-up).
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/0882
Date of REC Opinion
13 Jul 2017
REC opinion
Further Information Favourable Opinion