Clinical Trial to Evaluate Light-induced Skin Reactions After Application of Delgocitinib Cream
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT04361136
- Lead Sponsor
- LEO Pharma
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- Healthy subjects aged 18-64 years (inclusive).
- Fitzpatrick skin type of I, II, or III.
Key
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Delgocitinib cream 1 mg/g Delgocitinib cream Single topical occlusive administration Delgocitinib cream 3 mg/g Delgocitinib cream Single topical occlusive administration Delgocitinib cream 20 mg/g Delgocitinib cream Single topical occlusive administration Delgocitinib cream vehicle Delgocitinib cream vehicle Single topical occlusive administration Delgocitinib cream 8 mg/g Delgocitinib cream Single topical occlusive administration
- Primary Outcome Measures
Name Time Method Positive skin reaction at 24 hours or 48 hours after irradiation Up to 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
- Secondary Outcome Measures
Name Time Method Positive skin reaction at 24 hours after irradiation 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, erosionsPositive skin reaction at 48 hours after irradiation 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
Trial Locations
- Locations (1)
Bioskin Research Center Dermatology
🇩🇪Hamburg, Germany