Status:
COMPLETED
Clinical Trial to Evaluate Light-induced Skin Reactions After Application of Delgocitinib Cream
Lead Sponsor:
LEO Pharma
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
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 irritati...
Eligibility Criteria
Inclusion
- Key
- Healthy subjects aged 18-64 years (inclusive).
- Fitzpatrick skin type of I, II, or III.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
April 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2020
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04361136
Start Date
April 23 2020
End Date
May 30 2020
Last Update
February 24 2025
Active Locations (1)
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1
Bioskin Research Center Dermatology
Hamburg, Germany, 20095