Status:
COMPLETED
To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)
Lead Sponsor:
Castle Creek Pharmaceuticals, LLC
Conditions:
Epidermolysis Bullosa (EB)
Epidermolysis Bullosa Simplex
Eligibility:
All Genders
4+ years
Phase:
PHASE1
Brief Summary
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, in...
Detailed Description
This was an open-label, single-period study that intended to include subjects with EB consisting of infants/ children (ages 6 months to 11 years, inclusive) and adolescents/ adults (ages 12 years and ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
May 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03472287
Start Date
May 18 2018
End Date
February 14 2019
Last Update
February 10 2020
Active Locations (3)
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1
Stanford School of Medicine
Palo Alto, California, United States, 94304
2
Northwestern University Medical Center
Chicago, Illinois, United States, 60654
3
UNC Dermatology
Chapel Hill, North Carolina, United States, 27599