Healthy Volunteers
Conditions
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.
Interventions
Cream for topical application
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
All subjects will receive all treatments with treatments randomised over test fields.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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, erosions |
| Positive 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 |
Other
| 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 |
Countries
Germany
Outcome results
None listed