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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04807751
• Other study ID #: LP0133-1411
• Secondary ID: 2020-003090-22
• Status: Completed
• Phase: Phase 1
• Start date: March 25, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: April 2021
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• 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.

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).

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
Primary	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	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.
Secondary	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
Secondary	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