Status:
COMPLETED
Clinical Trial to Evaluate UV-light-induced Allergic Skin Reactions After Application of Delgocitinib Cream
Lead Sponsor:
LEO Pharma
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
Participants will have study medicine applied by site staff- delgocitinib cream or vehicle, and then exposed to UV light. The trial is designed to find out if delgocitinib cream can cause skin photoal...
Detailed Description
This is a single-centre, randomised, double-blind, vehicle-controlled, within-subject comparison phase 1 trial in Germany. The trial consists of a screening phase, an induction phase, a rest phase, a...
Eligibility Criteria
Inclusion
- Key
- Healthy subjects aged 18-64 years (inclusive).
- Fitzpatrick skin type of I, II, or III.
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 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.
- Any history of or presence of cancerous or precancerous skin lesions in general including melanoma, lentigo maligna, basal cell carcinoma, dysplastic naevi or actinic keratoses.
- History of or active or both photo-induced or photo-aggravated disease (e.g. cutaneous or lupus erythematodes, polymorphic light eruptions).
- Use of any topical or systemic medication that could interfere with the trial objective within 2 weeks before randomisation until subject's end of trial.
- Use of drugs that might cause photosensitising or phototoxic reactions within 4 weeks before randomisation until subject's end of trial.
- Foreseeable intensive UV-light exposure to test fields within 4 weeks before randomisation until subject's end of trial (solar or artificial).
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04807751
Start Date
March 25 2021
End Date
July 30 2021
Last Update
February 24 2025
Active Locations (1)
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1
Bioskin Research Center Dermatology
Hamburg, Germany, 20095