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To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)
Not Recruiting
Trial ID: NCT03472287
Purpose
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.
Official 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)
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
Intervention(s):
drug: Diacerein 1% Ointment
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Joyce Teng, MD