Skin Irritation Test of LEO 80185 Gel in Healthy Japanese Subjects

Inclusion criteria

• Signed informed consent has been obtained.
• Healthy Japanese male subjects.
• Aged 20 to 40 years inclusive.
• Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn).
• Subjects without a significant abnormality, as judged by the (sub)investigator

Exclusion criteria

• Body Mass Index outside the range 18-25 kg/m²
• History of alcohol or drug abuse.
• History of allergic reaction to any medications.
• Any disease that could in any way confound assessment of the test sites.
• Known or suspected hypersensitivity to any component of LEO 80185 gel.
• Known or suspected hepatic, renal or cardiac disorders.
• Known or suspected disorders of calcium metabolism associated with hypercalcaemia or albumin-corrected serum calcium above the reference range from the sample taken during screening.
• Subjects suspected of infection based on the infection testing results from the sample taken during screening (Hepatitis B surface antigen, HCV antibody, HIV antigen/antibody, serological test for syphilis).
• Use of systemic, locally injected or inhaled corticosteroids within 4 weeks of Day 1.
• Use of vitamin D or calcium supplements, or systemic vitamin D analogues within 4 weeks of Day 1.
• Use of any medication (systemic or topical) within 2 weeks of Day 1.
• Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks or 5 half-lives of Day 1, whichever is longest.
• Current participation in any other interventional clinical trial.
• Previously enrolled in this clinical trial.
• Previous or current photo-induced or photo-aggravated disease (e.g. abnormal response to sunlight).
• Exposure to excessive or chronic ultraviolet radiation (e.g. sunlight, sun lamps, tanning booths or photo-therapy) within 4 weeks of Day 1.
• Subjects (or their partner) not using an adequate method of contraception during the trial (Day 1-4).
• In the opinion of the (sub)investigator, participation in the trial is inappropriate.