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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Delgocitinib cream; Drug: Delgocitinib cream vehicle

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20095
    • Bioskin Research Center Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delgocitinib cream 20 mg/g; topical occlusive administration	Drug: Delgocitinib cream; Cream for topical application; Other Names: LEO 124249 cream
Placebo Comparator: Delgocitinib cream vehicle; topical occlusive administration	Drug: Delgocitinib cream vehicle; The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
No Intervention: Untreated skin; topical occlusive administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive skin reaction at 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.	Up to 72 hours after irradiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events from baseline to 14 days after subject's end of trial	Treatment-emergent adverse event	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.
Skin reaction score after irradiation during induction phase	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	up to Day 22
Skin reaction score after irradiation during the challenge phase (up to Day 40, Week 6).	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	up to Day 40

Collaborators and Investigators

• Sponsor: LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2021
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: LP0133-1411; 2020-003090-22 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
• IPD Sharing Time Frame: Data is available to request after results of the trial are available on leopharmatrials.com
• IPD Sharing Access Criteria: De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No