NCT03473197

A 6-Week Study to Evaluate the Photoallergic Potential of Diacerein 1% Ointment in Healthy Volunteers

A 6-Week, Randomized Study to Evaluate the Potential of CCP-020 (Diacerein 1%) Topical Ointment to Induce a Photoallergic Skin Reaction in Healthy Subjects, Using a Controlled Photopatch Test Design

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Castle Creek Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A study in healthy male and female adult volunteers to determine the potential of diacerein 1% ointment to induce a photoallergic skin reaction using a controlled photopatch testing procedure.

Detailed description

This was a randomized, single center, vehicle controlled, within-subject comparison study of diacerein 1% ointment and vehicle ointment applied under fully occlusive patch conditions on the infrascapular region of each subject's back to induce a photoallergic skin reaction following Ultraviolet (UV) irradiation. This was repeated twice each week during the 3-week Induction Phase, once during rest week 4 as applicable and once at Challenge Phase.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Diacerein 1% ointment	During the 3-week Induction Phase, diacerein 1% ointment and vehicle ointment were applied under fully occlusive patch conditions to two randomly assigned skin sites on the infrascapular region of the back twice each week for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. Following a rest period, during the Challenge Phase, the study products were applied to two naive sites once for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. A Re-Challenge was to be performed if a response observed during the Challenge Phase indicated photosensitization.

Timeline

• Start date: 2018-01-08
• Primary completion: 2018-03-09
• Completion: 2018-03-09
• First posted: 2018-03-22
• Last updated: 2020-02-05
• Results posted: 2020-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study