NCT04807751

Clinical Trial to Evaluate UV-light-induced Allergic Skin Reactions After Application of Delgocitinib Cream

A Phase 1 Clinical Trial to Evaluate the Photoallergic Potential of Delgocitinib Cream 20 mg/g After Topical Occlusive Application in Subjects With Healthy Skin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

Participants will have study medicine applied by site staff- delgocitinib cream or vehicle, and then exposed to UV light. The trial is designed to find out if delgocitinib cream can cause skin photoallergy after UV-light exposure in people with healthy skin.

Detailed description

This is a single-centre, randomised, double-blind, vehicle-controlled, within-subject comparison phase 1 trial in Germany. The trial consists of a screening phase, an induction phase, a rest phase, and a challenge phase. There will be 2 columns of test fields on each participant's back with the 3 treatments in either column for a total of 6 treatments. One column of test fields will be irradiated and the other will not be irradiated. All participants will be exposed to UV-light on skin treated delgocitinib cream or vehicle and on untreated skin on test fields to be irradiated.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Delgocitinib cream	Cream for topical application
DRUG	Delgocitinib cream vehicle	The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Timeline

• Start date: 2021-03-25
• Primary completion: 2021-07-30
• Completion: 2021-07-30
• First posted: 2021-03-19
• Last updated: 2025-02-24

Locations

1 site across 1 country: Germany