CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 234 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/NCT03472547
NCT03472547Phase 1Completed
CompareCT.gov

A Randomized, Controlled Study to Evaluate the Sensitizing Potential of CCP-020 (Diacerein 1%) Topical Ointment in Healthy Subjects Using a Repeat Insult Patch Test Design

Castle Creek Pharmaceuticals, LLC·interventional·Posted Mar 21, 2018·Updated Oct 21, 2019

In Brief

A Phase 1 clinical trial evaluating diacerein 1% ointment for Healthy. Completed, enrolled 234 participants across 1 site.

Detailed Summary

Single center, randomized, controlled, evaluator blinded, within-subject study to evaluate the sensitization potential of diacerein 1% ointment under occlusive conditions on normal skin of healthy volunteer subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMar 21, 2018
Enrollment StartJan 15, 2018
Primary CompletionMar 3, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.3 years ago

Interventions

diacerein 1% ointmentdrug

All subjects were exposed to diacerein 1% ointment, vehicle ointment, and 0.9% saline (negative control) at 3 randomly assigned, adjacent skin sites on the infrascapular area of the back 3 times weekly for 3 weeks (9 applications) during the Induction Phase, and one time during the Challenge Phase (10 times in total).