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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04361136
• Other study ID #: LP0133-1408
• Secondary ID: 2019-000705-67
• Status: Completed
• Phase: Phase 1
• Start date: April 23, 2020
• Est. completion date: May 30, 2020

Study information

• Verified date: October 2020
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Delgocitinib cream
Cream for topical application
• Delgocitinib cream vehicle
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Locations

Country	Name	City	State
Germany	Bioskin Research Center Dermatology	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of treatment-emergent adverse events from baseline to Day 4		From time of first investigational medicinal product application (Day 1) until Day 4
Primary	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	Positive skin reaction at 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	24 hours after irradiation
Secondary	Positive skin reaction at 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	48 hours after irradiation