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

Phase 1

Completed

• Conditions: Psoriasis Vulgaris
• Interventions: Drug: Petrolatum ointment; Drug: Vehicle; Drug: LEO 90100

• Registration Number: NCT01935869
• Lead Sponsor: LEO Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2013-09-02
• Study First Posted: 2013-09-05
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2015-07
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Petrolatum ointment	Petrolatum ointment	-
Vehicle	Vehicle	-
LEO 90100	LEO 90100	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with positive sensitisation reaction at each test site in the challenge phase	6 weeks
Mean Cumulative Irritation index and maximal dermal response during induction phase	3 weeks

Trial Locations

Locations (1)

CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Hôpital de l'Archet 2; 🇫🇷 Nice Cedex 3, France