Clinical trial NCT04807751: Clinical Trial to Evaluate UV-light-induced Allergic Skin Reactions After Application of Delgocitinib Cream
Official title: A Phase 1 Clinical Trial to Evaluate the Photoallergic Potential of Delgocitinib Cream 20 mg/g After Topical Occlusive Application in Subjects With Healthy Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2021-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will receive all treatments with treatments randomised over test fields.
Primary purpose: OTHER

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 photoallergy after UV-light exposure in people with healthy skin.

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, and a challenge phase. There will be 2 columns of test fields on each participant's back with the 3 treatments in either column for a total of 6 treatments. One column of test fields will be irradiated and the other will not be irradiated. All participants will be exposed to UV-light on skin treated delgocitinib cream or vehicle and on untreated skin on test fields to be irradiated.

Eligibility criteria: Key Inclusion Criteria:

* Healthy subjects aged 18-64 years (inclusive).
* Fitzpatrick skin type of I, II, or III.

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 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).

Primary outcomes:
measure: Positive skin reaction at 72 hours after irradiation
timeFrame: Up to 72 hours after irradiation
Secondary outcomes:
measure: Number of adverse events from baseline to 14 days after subject's end of trial
timeFrame: From baseline to 14 days after subject's end of trial (Day 5 of challenge phase, or if applicable Day 5 of re-challenge phase.
measure: Skin reaction score after irradiation during induction phase
timeFrame: up to Day 22
measure: Skin reaction score after irradiation during the challenge phase (up to Day 40, Week 6).
timeFrame: up to Day 40
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Bioskin Research Center Dermatology
Study officials:
References: