A double-blind, randomized, placebo-controlled, dose finding study of R126638 given as a single or repeat dose in oral solution vs placebo in the treatment of pityriasis versicolor. - Dose finding study of R126638 in pityriasis versicolor

Barrier Therapeutics Inc.0 个研究点目标入组 144 人开始时间: 2005年12月20日最近更新: 2020年4月6日

试验速览

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•1.Subject has completed an appropriately administered informed consent/assent
•2.Subject is at least 18 years of age and of either sex.
•3.The subject has a clinical diagnosis of pityriasis (tinea) versicolor with at least mild desquamation present, and confirmation of Malassezia spp. by KOH microscopy.
•4.The subject has multiple lesions in at least two of the following anatomic areas: face, neck, arms, chest, abdomen, back, and legs; or, in the investigator’s opinion, at least moderately extensive skin involvement defined as > 15% BSA.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.Subject has a history of sensitivity to any of the ingredients in the study medication
•2.Subject is currently participating in, or has within the 30 days prior to the clinical trial participated in an investigational clinical trial.
•3.Subject has used systemic or topical steroids, or topical antifungal therapy, including shampoos with active ingredients against Malassezia spp. or tar shampoos within the previous 30 days.
•4.Subject has used systemic antifungal therapy within the previous 60 days.
•5.Subject has received medications within the previous 14 days that are known to prolong the QT interval, that are contraindicated during azole treatment, that are known to influence the bioavailability of azoles, or that reduce gastric acidity which interferes with the absorption of some azoles.
•6.The subject has an ECG prior to dosing with a QTcB or QTcF interval >450 milliseconds (if male) or >470 milliseconds (if female) as determined by the central ECG lab, or abnormal morphology of the ECG, or clinically serious arrhythmia.

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