A Study Evaluating Skin Irritation, Phototoxicity and Safety After Administration of LEO 90105 on… (NCT01293357) | Clinical Trial Compass
CompletedPhase 1
A Study Evaluating Skin Irritation, Phototoxicity and Safety After Administration of LEO 90105 on Intact Skin of Healthy Japanese Male Subjects
Japan20 participantsStarted 2010-12
Plain-language summary
The objective of the trial is to investigate skin irritation, phototoxicity and safety of LEO 90105 and its components by patchtest (48 hours closed patch test and photo patch test) in healthy Japanese male subjects.
Who can participate
Age range20 Years – 40 Years
SexMALE
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Inclusion Criteria:
* Healthy Japanese male subjects,
* Aged 20 to 40 years inclusive.
* Subjects without signs of skin irritation (erythema,dryness, roughness or scaling) on test sites.
* 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:
* Body mass Index (BMI ) (body weight (kg)/height(m)²) outside the range 18-25 kg/m2
* History of alcohol, chemical or drug abuse
* History of allergic reaction to drugs or history of skin reaction to the tape
* Any systemic or cutaneous disease that could in any way confound interpretation of the study results (e.g. atopic dermatitis, eczema, psoriasis)
* Known sensitivity to any component of any of the formulations being tested
* Known hepatic or renal disorders
* Use of systemic, locally injected or inhaled corticosteroids within 4 weeks of study start (Day 1)
* Use of systemic vitamin D analogues, vitamin D or calcium supplements within 4 weeks of study start(Day 1)
* Use of any drug (systemic or topical) within 2 weeks of study start (Day 1)
* Use of non-marketed/other investigational products one month prior to or 5 half lives (for those the half life is longer than one month) and during the trial is not permitted
* Any abnormality found at medical interview before administrati…