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

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Psoriasis Vulgaris

Treatments: Drug: Vehicle; Drug: Petrolatum ointment; Drug: LEO 90100

Study type: Interventional

Funder types: Industry

Identifiers

NCT01935869

LP0053-66

Details and patient eligibility

About

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.

Enrollment: 224 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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224 participants in 3 patient groups, including a placebo group

LEO 90100

Experimental group

Treatment:

Drug: LEO 90100

Vehicle

Placebo Comparator group

Treatment:

Drug: Vehicle

Petrolatum ointment

Other group

Treatment:

Drug: Petrolatum ointment