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

NCT04807751 | Completed Phase 1

• 2 other identifiers: LP0133-14112020-003090-22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• Skin reaction score after irradiation during induction phase

  up to Day 22

• Skin reaction score after irradiation during the challenge phase (up to Day 40, Week 6).

  up to Day 40

Study Arms (3)

Delgocitinib cream 20 mg/g

EXPERIMENTAL

topical occlusive administration

Drug: Delgocitinib cream

Delgocitinib cream vehicle

PLACEBO COMPARATOR

topical occlusive administration

Drug: Delgocitinib cream vehicle

Untreated skin

NO INTERVENTION

topical occlusive administration

Interventions

Delgocitinib cream DRUG

Cream for topical application

Also known as: LEO 124249 cream

Delgocitinib cream 20 mg/g

Delgocitinib cream vehicle DRUG

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

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 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).

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Bioskin Research Center Dermatology

Hamburg, 20095, Germany

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• 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: March 18, 2021
• First Posted: March 19, 2021
• Study Start: March 25, 2021
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: April 28, 2026

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)