Clinical Trial to Evaluate Light-induced Skin Reactions After Application of Delgocitinib Cream

A Phase 1 Clinical Trial to Evaluate the Phototoxic Potential of Delgocitinib Cream After Single Topical Occlusive Application on Healthy Skin

This is a single-centre, randomised, vehicle-controlled, double-blind, within-subject comparison phase 1 clinical trial. The trial is designed to find out if delgocitinib cream can cause skin irritation after light exposure in people with healthy skin.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Delgocitinib cream; Drug: Delgocitinib cream vehicle

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20095
    • Bioskin Research Center Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• Healthy subjects aged 18-64 years (inclusive).
• Fitzpatrick skin type of I, II, or III.

Key Exclusion Criteria:

• Atopic dermatitis, eczema, psoriasis, acne, dermatitis solaris or suntan that could interfere with the test field evaluation, hyperpigmentation, multiple naevi, tattoos, blemishes or dense body hair in the range of the test fields.
• Any history of or presence of cancerous or precancerous skin lesions.
• Any other skin disease or other visible skin condition noted on physical examination which in the investigator's opinion might interfere with the evaluation of the test field reaction.
• Known disease that can be induced by ultraviolet (UV) light.
• Use of any topical or systemic medication which could interfere with the trial objective within 2 weeks before randomisation until end of trial.
• Use of drugs which might cause photobiologic or phototoxic reactions within 4 weeks before randomisation until end of trial.
• Foreseeable intensive UV light exposure (solar or artificial) to test fields within 4 weeks before randomisation until end of trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delgocitinib cream 1 mg/g; Single topical occlusive administration	Drug: Delgocitinib cream; Cream for topical application; Other Names: LEO 124249 cream
Experimental: Delgocitinib cream 3 mg/g; Single topical occlusive administration	Drug: Delgocitinib cream; Cream for topical application; Other Names: LEO 124249 cream
Experimental: Delgocitinib cream 8 mg/g; Single topical occlusive administration	Drug: Delgocitinib cream; Cream for topical application; Other Names: LEO 124249 cream
Experimental: Delgocitinib cream 20 mg/g; Single topical occlusive administration	Drug: Delgocitinib cream; Cream for topical application; Other Names: LEO 124249 cream
Placebo Comparator: Delgocitinib cream vehicle; Single topical occlusive administration	Drug: Delgocitinib cream vehicle; The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.; Other Names: LEO 124249 cream vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive skin reaction at 24 hours or 48 hours after irradiation	A reaction is considered positive if the skin reaction score for the irradiated test field is at least 1 point higher than both the non-irradiated test field exposed to the same strength of IMP, and the irradiated control field. The grading for the skin reaction score will be performed according to the following 5-point scale: 0 No reaction; 1 Erythema; 2 Erythema with dermal infiltrate; 3 Erythema with papulovesicles; 4 Erythema with blisters, erosions	Up to 48 hours after irradiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive skin reaction at 24 hours after irradiation	A reaction is considered positive if the skin reaction score for the irradiated test field is at least 1 point higher than both the non-irradiated test field exposed to the same strength of IMP, and the irradiated control field. The grading for the skin reaction score will be performed according to the following 5-point scale: 0 No reaction; 1 Erythema; 2 Erythema with dermal infiltrate; 3 Erythema with papulovesicles; 4 Erythema with blisters, erosions	24 hours after irradiation
Positive skin reaction at 48 hours after irradiation	A reaction is considered positive if the skin reaction score for the irradiated test field is at least 1 point higher than both the non-irradiated test field exposed to the same strength of IMP, and the irradiated control field. The grading for the skin reaction score will be performed according to the following 5-point scale: 0 No reaction; 1 Erythema; 2 Erythema with dermal infiltrate; 3 Erythema with papulovesicles; 4 Erythema with blisters, erosions	48 hours after irradiation

Other Outcome Measures

Outcome Measure	Time Frame
Number of treatment-emergent adverse events from baseline to Day 4	From time of first investigational medicinal product application (Day 1) until Day 4

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Medical Expert, LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2020
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: LP0133-1408; 2019-000705-67 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
• IPD Sharing Time Frame: Data is available to request after results of the trial are available on leopharmatrials.com
• IPD Sharing Access Criteria: De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No