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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Delgocitinib cream
* Drug: Delgocitinib cream vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All subjects will receive all treatments with treatments randomised over test fields.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |