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

Sponsor

LEO Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT04807751

Collaborator

(none)

Enrollment

Location

Arms

4.2

Actual Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Delgocitinib cream Drug: Delgocitinib cream vehicle	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

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

Actual Study Start Date :

Mar 25, 2021

Actual Primary Completion Date :

Jul 30, 2021

Actual Study Completion Date :

Jul 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Positive skin reaction at 72 hours after irradiation [Up to 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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bioskin Research Center Dermatology	Hamburg		Germany	20095

Sponsors and Collaborators

LEO Pharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LEO Pharma

ClinicalTrials.gov Identifier:

NCT04807751

Other Study ID Numbers:

LP0133-1411
2020-003090-22

First Posted:

Mar 19, 2021

Last Update Posted:

Aug 3, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 3, 2021