Trial Search Results
Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex
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 were previously enrolled in studies CCP-020-301 or CCP-020-101.
Stanford is currently accepting patients for this trial.
Castle Creek Pharmaceuticals, LLC
- Drug: Diacerein 1% Ointment
- In the opinion of the Investigator, the subject is capable of understanding and
complying with protocol requirements.
- The subject or, when applicable, the subject's legally acceptable representative signs
and dates a written, informed consent/assent form and any required privacy
authorization prior to the initiation of any study procedures.
- Subject has a documented genetic mutation consistent with EBS.
- Subject has completed study CCP-020-301 or participated in study CCP-020-101.
- Subject/caregiver agrees to report use of any topical therapies applied to EBS lesions
(e.g. medicated cleansers, bleach cleansers, bleach baths, topical antiseptics,
topical disinfectants, etc.).
- If the subject is a woman of childbearing potential, she has a negative urine
pregnancy test and agrees to use an approved effective method of birth control, as
defined by this protocol, for the duration of the study.
- Subject is non-lactating and is not planning for pregnancy during the study period.
- Subject is willing and able to follow all study instructions and to attend all study
- Subject has EBS lesions to be treated that are infected (i.e., EBS lesions that
require topical antibiotic therapy to treat an infection).
- Subject has evidence of a systemic infection or has used systemic antibiotics within 7
days prior to Baseline Visit.
- The subject was discontinued from the feeder study due to an adverse event judged to
be related or possibly related to the study medication.
- Subject has experienced a change in clinical status from the feeder study that, in the
investigator's opinion, puts the subject at undue risk to participate.
Ages Eligible for Study
6 Months - 99 Years
Genders Eligible for Study