NCT03473184

A 4-Day Study to Evaluate the Photoxicity of Diacerein 1% Topical Ointment in Healthy Volunteers

A 4 Day, Randomized Study to Evaluate the Potential of CCP-020 (Diacerein 1%) Topical Ointment to Induce a Phototoxicity Skin Reaction in Healthy Subjects, Using a Controlled Photopatch Test

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Castle Creek Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study was designed to assess the phototoxic potential of diacerein 1% ointment when application is followed by light exposure.

Detailed description

This was a single-center, randomized, within-subject comparison of diacerein 1% ointment and vehicle ointment applied to 2 sites on opposite sides of the the infrascapular area of the back under occlusive patch conditions for approximately 24 (±2) hours. Product was applied according to the randomization scheme in an amount of 0.2 mL, once during the study. Patches were removed and 1 of the skin sites for each product was irradiated and 1 remained non-irradiated. The irradiated and non-irradiated sites were compared with each other and with an untreated irradiated control site.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Diacerein 1% ointment	Diacerein 1% ointment and vehicle ointment were applied on Day 1 at two randomly assigned skin sites on each side of the lower thoracic area of the back according to a randomization scheme. One side of the back was irradiated on Day 2, including an untreated irradiated control site, and the other side was to remain non-irradiated.

Timeline

• Start date: 2017-12-12
• Primary completion: 2017-12-15
• Completion: 2017-12-15
• First posted: 2018-03-22
• Last updated: 2020-02-10
• Results posted: 2020-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study