Skin Irritation of LEO 90100 Foam (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Psoriasis Vulgaris

Treatments: Drug: LEO 90100 foam; Drug: Vehicle of LEO 90100 foam

Study type: Interventional

Funder types: Industry

Identifiers

NCT03442244

LP0053-1007

Details and patient eligibility

About

This trial is looking at whether the LEO 90100 foam causes irritation of the skin in healthy Japanese male adults without psoriasis. A single application of LEO 90100 foam and its vehicle will each be made to 2 body sites in 20 subjects.

Enrollment: 20 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Signed informed consent has been obtained.
• Healthy Japanese male subjects.
• Aged 20 to 40 years inclusive.

Key Exclusion Criteria:

• Body Mass Index outside the range 18-25 kg/m²
• Use of any medication (systemic or topical) within 2 weeks of Day 1.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

LEO 90100 foam

Experimental group

Description:

Each subject has each of the 2 investigational products applied at the same time on 2 sites on the back. The location on which the treatments are applied is randomised in a double-blinded manner LEO 90100 foam contains Calcipotriol hydrate 52.2 μg/g (equivalent to 50.0 μg/g calcipotriol) plus Betamethasone dipropionate 0.643 mg/g

Treatment:

Drug: LEO 90100 foam

Vehicle foam

Placebo Comparator group

Description:

Each subject has each of the 2 investigational products applied at the same time on 2 sites on the back. The location on which the treatments are applied is randomised in a double-blinded manner. Foam vehicle does not contain active ingredients

Treatment:

Drug: Vehicle of LEO 90100 foam