CLINICAL EFFICACY EVALUATION OF A FIXED COMBINATION OF CALCITRIOL 3 µg/g WITH THREE CONCENTRATIONS (100, 250, 500µg/g) OF CLOBETASOL PROPIONATE AS SPRAY FORMULATION USING THE MODIFIED DUMAS-SCHOLTZ PSORIASIS MINI PLAQUE TEST UNDER NON-OCCLUSIVE CONDITIONS

GALDERMA R&D SNC0 个研究点目标入组 32 人开始时间: 2007年1月23日最近更新: 2022年4月4日

适应症

试验速览

暂无简介。

•1. The subject is male or female and at least 18 years old
•2. The subject presents 8 target sites on one or more psoriasis plaques
•3. If the subject is a female:
•3.1 Of childbearing potential: one of the following contraception methods needs to be used by her for at least 5 consecutive weeks prior to study entry date and during the study:
•- Oral contraception,
•- Intra Uterine Device,
•- Contraceptive patches, Injectable or implantable contraception
•- Sexual abstinence
•- Condom or partner with a vasectomy.
•3.2 Of non-childbearing potential: she needs to be postmenopausal (absence of menstrual bleeding for 2 years) or had a hysterectomy, bilateral tubal ligation or bilateral ovariectomy
•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. The subject has an underlying disease, which in the investigator’s opinion, would put the Subject at risk (e.g., uncontrolled chronic or serious diseases which would normally prevent participation in any clinical trial, such as a cancer, AIDS, severe cardiopathy),
•2. The subject has an underlying disease, which in the investigator’s opinion, may confound the study assessments (e.g., other dermatological diseases, such as a dermatitis, eczema, etc.)
•3. The female subject with a positive pregnancy test at baseline visit, breast-feeding or planning a pregnancy during the course of the study
•4. The subject has acute guttate, pustular or erythrodermic psoriasis.

发起方

GALDERMA R&D SNC