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Completed

NCT Number: NCT04807751

Clinical Trial to Evaluate UV-light-induced Allergic Skin Reactions After Application of Delgocitinib Cream

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.

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Key information

Conditions

Healthy

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bioskin Research Center Dermatology

Hamburg, 20095, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Delgocitinib cream

Drug

Cream for topical application

Other names: LEO 124249 cream

Delgocitinib cream vehicle

Drug

The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Primary outcomes

  1. Positive skin reaction at 72 hours after irradiation

    Time frame: Up to 72 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 evaluation of skin reaction at the end of the challenge phase performed using the following scale:

    • 0 negative
    • 1 equivocal
    • 2 positive. A positive score indicates presence of a UV-light-induced allergic skin reaction.

Secondary outcomes

  1. Number of adverse events from baseline to 14 days after subject's end of trial

    Time frame: 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.

    Treatment-emergent adverse event

  2. Skin reaction score after irradiation during induction phase

    Time frame: up to Day 22

    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

  3. Skin reaction score after irradiation during the challenge phase (up to Day 40, Week 6).

    Time frame: up to Day 40

    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

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 19, 2021
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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