NCT03472534

A 21 Day Irritation Study in Healthy Volunteers With Diacerein 1% Ointment

A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of CCP-020 (Diacerein 1%) Topical Ointment in Healthy Subjects Using a Cumulative Irritant Patch Test Design

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Castle Creek Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Single center, randomized, controlled, evaluator blinded, within-subject study to evaluate the irritation potential of diacerein1% ointment on normal skin of healthy volunteers, using a cumulative irritancy patch test (CIPT) procedure.

Detailed description

This study was designed to assess the cumulative irritation potential of diacerein 1% ointment in comparison with vehicle ointment, 0.2% sodium lauryl sulfate (SLS) (positive control), and 0.9% saline (negative control) on normal skin of healthy volunteers using a cumulative irritancy patch test (CIPT) procedure applied once daily for 21 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	diacerein 1% ointment	diacerein 1% ointment applied to the skin of the infrascapular area of the back under occlusive patch for 21 days.

Timeline

• Start date: 2018-01-09
• Primary completion: 2018-01-30
• Completion: 2018-01-30
• First posted: 2018-03-21
• Last updated: 2020-02-05
• Results posted: 2020-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study