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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: LEO Pharma
• Treatments: Petrolatum

Criteria

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)