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.

Lead Sponsor:

Castle Creek Pharmaceuticals, LLC

Stanford Investigator(s):

Intervention(s):

  • Drug: Diacerein 1% Ointment

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - 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
   visits.

Exclusion Criteria:

   - 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

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elidia V Tafoya
6507241982
Not Recruiting