Epidermolysis Bullosa Clinical Trial
Official title:
An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex (EBS)
The primary objective of this study is to evaluate the long term safety and tolerability of diacerein 1% ointment for 2 treatment cycles in subjects with EBS that previously participated in the CCP-020-301 or the CCP-020-101 studies.
This is an international, multicenter, open-label, long term extension study evaluating the
safety of topical Diacerein 1% Ointment for the treatment of subjects with EBS. At Visit 1,
EBS subjects who completed the CCP-020-301 double-blind safety and efficacy study or
participated in the CCP-020-101 PK study (feeder studies) who meet all the
inclusion/exclusion criteria will be eligible to complete 2 treatment cycles of CCP-020.
Each treatment cycle will consist of 8 weeks on treatment (once-daily, at home study
medication applications) followed by 8 weeks off treatment (only Investigator approved bland,
non-medicated emollient/moisturizer, routine cleansing products and sunscreens) with a
maximum of 2 treatment cycles allowed for up to 52 weeks.
At Baseline Visit (corresponding to the final study visit of the feeder study), the
investigator will perform a clinical assessment and determine if any of the subject's lesions
require treatment (up to 30% BSA). If the subject has active lesions as determined by the
Investigator's clinical assessment, the subject will initiate a cycle of once-daily, at home
study medication application to their EBS lesions for 8 weeks (treatment period) followed by
an 8-week period where no treatment will be administered. Subjects presenting with no active
lesions (as determined by the Investigator's clinical assessment) will not begin treatment
and instead, will be instructed to return to the clinic for re-evaluation in 8 weeks or upon
worsening of EBS lesions, whichever happens first.
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