A Study Evaluating the Safety of LEO 90105 and Its Vehicle, After Multiple Administration on Inta… (NCT01293383) | Clinical Trial Compass
CompletedPhase 1
A Study Evaluating the Safety of LEO 90105 and Its Vehicle, After Multiple Administration on Intact Skin of Healthy Japanese Male Subjects
Japan12 participantsStarted 2011-03
Plain-language summary
The purpose of this trial is to to investigate the safety of LEO 90105 compared with its vehicle after multiple administration (twice daily, 5 days) in healthy Japanese male subjects.
Who can participate
Age range20 Years – 40 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy Japanese male subjects
* Aged 20 to 40 years inclusive
* Subjects without signs of skin irritation (erythema, dryness, roughness or scaling) on the test site
* Subjects willing to follow the study procedures and complete the study
* Subjects having understood and signed a written informed consent
* Subjects without abnormal in physiological test and clinical test in screening, and also judged as possible to participant the study by investigators
Exclusion Criteria:
* Subjects with Body mass Index (BMI ) (body weight(kg)/height (m)²) outside the range 18-25 kg/m2(18≤BMI\<25)
* Subjects with history of alcohol, chemical or drug abuse
* Subjects with history of allergic reaction to any content of the study medication
* Subjects with systemic or cutaneous disease that could in any way confound interpretation of the study results (e.g. atopic dermatitis, eczema, psoriasis)
* Subjects with known sensitivity to any component of any of the formulations being tested
* Subjects with known hepatic, renal or cardiac disorders
* Subjects using systemic, locally injected or inhaled corticosteroids within 4 weeks of study start (Day 1)
* Subjects using systemic vitamin D analogues,vitamin D or calcium supplements within 4 weeks of study start (Day 1)
* Subjects using any drug (systemic or topical) within 2 weeks of study start (Day 1)
* Subjects using non-marketed/other investigational products one month prior to or 5 half lives (for those the half life is l…