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

LEO Pharma logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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