CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 11 enrolled
Drug / intervention
Diacerein 1% Ointmentdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03472287
NCT03472287Phase 1Completed
CompareCT.gov

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)

Castle Creek Pharmaceuticals, LLC·interventional·Posted Mar 21, 2018·Updated Feb 10, 2020

In Brief

A Phase 1 clinical trial evaluating Diacerein 1% Ointment for Epidermolysis Bullosa (EB) and 3 related conditions. Completed, enrolled 11 participants across 3 sites.

Detailed 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, 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpidermolysis Bullosa (EB), Epidermolysis Bullosa Simplex, Dystrophic Epidermolysis Bullosa, Junctional Epidermolysis Bullosa
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMar 21, 2018
Enrollment StartMay 18, 2018
Primary CompletionJan 31, 2019
Study CompletionFeb 14, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.3 years ago

Interventions

Diacerein 1% Ointmentdrug

Diacerein 1% Ointment administered topically