Skip to main content
OpenTrials
Completed

NCT Number: NCT04361136

Clinical Trial to Evaluate Light-induced Skin Reactions After Application of Delgocitinib Cream

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.

Completed

Looking for future studies?

Notify Me

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

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.

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.

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.

Other names: LEO 124249 cream vehicle

Primary outcomes

  1. Positive skin reaction at 24 hours or 48 hours after irradiation

    Time frame: 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 outcomes

  1. Positive skin reaction at 24 hours after irradiation

    Time frame: 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

  2. Positive skin reaction at 48 hours after irradiation

    Time frame: 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 outcomes

  1. Number of treatment-emergent adverse events from baseline to Day 4

    Time frame: From time of first investigational medicinal product application (Day 1) until Day 4

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

A Phase 1 Clinical Trial to Evaluate the Phototoxic Potential of Delgocitinib Cream After Single Topical Occlusive Application on Healthy Skin

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2020
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.