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

NCT04361136 | Completed Phase 1 FDA Drug

• 2 other identifiers: LP0133-14082019-000705-67
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Positive skin reaction at 24 hours or 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

  Up to 48 hours after irradiation

Secondary Outcomes (2)

• Positive skin reaction at 24 hours after irradiation

  24 hours after irradiation

• Positive skin reaction at 48 hours after irradiation

  48 hours after irradiation

Other Outcomes (1)

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

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

Study Arms (5)

Delgocitinib cream 1 mg/g

EXPERIMENTAL

Single topical occlusive administration

Drug: Delgocitinib cream

Delgocitinib cream 3 mg/g

EXPERIMENTAL

Single topical occlusive administration

Drug: Delgocitinib cream

Delgocitinib cream 8 mg/g

EXPERIMENTAL

Single topical occlusive administration

Drug: Delgocitinib cream

Delgocitinib cream 20 mg/g

EXPERIMENTAL

Single topical occlusive administration

Drug: Delgocitinib cream

Delgocitinib cream vehicle

PLACEBO COMPARATOR

Single topical occlusive administration

Drug: Delgocitinib cream vehicle

Interventions

Delgocitinib cream DRUG

Cream for topical application

Also known as: LEO 124249 cream

Delgocitinib cream 1 mg/g; Delgocitinib cream 20 mg/g; Delgocitinib cream 3 mg/g; Delgocitinib cream 8 mg/g

Delgocitinib cream vehicle DRUG

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

Also known as: LEO 124249 cream vehicle

Delgocitinib cream vehicle

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Bioskin Research Center Dermatology

Hamburg, 20095, Germany

Location

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will receive all treatments with treatments randomised over test fields.

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: April 23, 2020
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: April 28, 2026

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)