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Trial record 5 of 11 for:    LP0133

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

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ClinicalTrials.gov Identifier: NCT04807751
Recruitment Status : Completed
First Posted : March 19, 2021
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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.

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Study Type : Interventional  (Clinical Trial)
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.
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 : March 25, 2021
Actual Primary Completion Date : July 30, 2021
Actual Study Completion Date : July 30, 2021

Arm Intervention/treatment
Experimental: Delgocitinib cream 20 mg/g
topical occlusive administration
Drug: Delgocitinib cream
Cream for topical application
Other Name: 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



Primary Outcome Measures :
  1. Positive skin reaction at 72 hours after irradiation [ Time Frame: 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 :
  1. Number of adverse events from baseline to 14 days after subject's end of trial [ Time Frame: 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

  2. Skin reaction score after irradiation during induction phase [ Time Frame: 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

  3. Skin reaction score after irradiation during the challenge phase (up to Day 40, Week 6). [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04807751


Locations
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Germany
Bioskin Research Center Dermatology
Hamburg, Germany, 20095
Sponsors and Collaborators
LEO Pharma
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT04807751    
Other Study ID Numbers: LP0133-1411
2020-003090-22 ( EudraCT Number )
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data is available to request after results of the trial are available on leopharmatrials.com
Access Criteria: Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
URL: http://leopharmatrials.com/for-professionals

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No