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Completed

NCT Number: NCT01935869

Combined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100

The purpose of this study is to determine the skin irritation potential and sensitisation potential of LEO 90100 and the vehicle after repeated applications on the skin of healthy subjects.

Completed

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Key information

Conditions

Psoriasis Vulgaris

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Hôpital de l'Archet 2

Nice, 06202, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Following verbal and written information about the trial, subject must provide signed and dated informed consent before any study related activities are carried out.
  • 2. Healthy male or female subjects, 18 to 65 years of age inclusive at screening.

Exclusion criteria

  • 1. Female subjects who are pregnant, of childbearing potential and who wish to become pregnant during the study, or who are breast feeding
  • 2. Subjects with any systemic or cutaneous disorder that might interfere with the evaluation of the test site reactions (e.g. atopic dermatitis, contact eczema, psoriasis) 3. Subjects with scars, moles or other abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the study results (skin type V and VI on the Fitzpatrick scale)

Treatment and study plan

LEO 90100

Drug

Vehicle

Drug

Petrolatum ointment

Drug

Primary outcomes

  1. Mean Cumulative Irritation index and maximal dermal response during induction phase

    Time frame: 3 weeks

  2. Number of subjects with positive sensitisation reaction at each test site in the challenge phase

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 5, 2013
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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