Education and Training
To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)
A pharmacokinetic (PK) study in 16-20 EB subjects to be allocated to two cohorts. Cohort 1 to include 8-10 subjects (ages 12 yrs and older); Cohort 2 to include 8-10 subjects (ages 6 months-11 yrs, inclusive). Cohort 2 only included subjects 4 yrs and older. Serial PK blood sampling collected on Days 1 and 10. Analyses were performed to determine the concentrations of diacerein and rhein.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: Diacerein 1% Ointment
Eligibility
Key Inclusion Criteria:
- At least 12 years of age (Cohort 1) or at least 6 months of age to 11 years, inclusive
(Cohort 2) at screening. For US only: at least 4 years of age to 11 years, inclusive
(Cohort 2)
- The subject must weigh at least 9 kg (19.8 lbs) at Screening.
- Subject has a documented genetic mutation consistent with EB.
- Subject has EB lesions on ≥ 2% body surface area (BSA) and the EB lesions are in the
following body areas: a. Localized: plantar and/or palmar areas, b. Generalized: arms,
legs, torso, hands and feet.
Key Exclusion Criteria:
- Subject has EB lesions where drug will be applied that are infected
- Subject has used any diacerein containing product within 1 month prior to Visit 1
- Subject has used systemic immunotherapy or cytotoxic chemotherapy within 60 days prior
to dosing.
- Subject has used systemic steroidal therapy or has used topical steroidal therapy on
the EB lesions in the application area within 14 days prior to dosing
- Subject has participated in an investigational drug trial in which administration of
an investigational study medication occurred within 30 days prior to dosing
Ages Eligible for Study
4 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Joyce Teng, MD
Not Recruiting