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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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LEO 90100

Group Type EXPERIMENTAL

LEO 90100

Intervention Type DRUG

Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Petrolatum ointment

Group Type OTHER

Petrolatum ointment

Intervention Type DRUG

Interventions

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LEO 90100

Intervention Type DRUG

Vehicle

Intervention Type DRUG

Petrolatum ointment

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes