CCP-020-101 Diacerein 1% in patients with EB
Research type
Research Study
Full title
A Multi-center Study to Evaluate the Pharmacokinetics of Diacerein and Rhein and the Safety of Diacerein after Maximum Use, Topical Administration of CCP-020 (Diacerein 1% ointment) to Patients with Epidermolysis Bullosa (EB).
IRAS ID
244305
Contact name
Anna Martinez
Contact email
Sponsor organisation
Castle Creek Pharmaceutical, LLC
Eudract number
2018-000439-29
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This is a Phase I, open label, single period study in approximately 16-20 participants with Epidermolysis Bullosa (EB) ranging in age from 6 months or older. The study will be conducted in two cohorts:
1. Participants aged 12 years or Older
2. Participants aged 6 months to 11 years.The purpose of the study is to descriptively characterise the single-dose and steady state pharmacokinetics (PK) of Diacerein and its active metabolite, rhein, after topical application of CCP-020 under maximum use conditions in Infants/Children and Adolescents/Adult participants with EB. The study will also assess the safety and tolerability of single-dose and steady state topical application of CCP-020 in participants with EB as its secondary objectives.
Diacerein 1% Ointment is a topical ointment containing the active ingredient diacerein. Diacerein is a highly purified derivative in the anthraquinone family of drugs. Diacerein and its active metabolite “rhein” have shown to inhibit the production and activity of pro-inflammatory factors, linked to auto-inflammatory effects on the skin. Diacerein acts via a novel mechanism that differentiates it from non-steroidal anti-inflammatory drugs (NSAIDs).
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0115
Date of REC Opinion
4 Jun 2018
REC opinion
Further Information Favourable Opinion