Plasma Pharmacokinetics study of CD5024 1% cream in subjects with papulopustular rosacea

GALDERMA R&D SNC0 个研究点目标入组 15 人开始时间: 2008年5月19日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•1. The subject is a male or female who is at least 18 years old at Screening visit,
•2. The subject has severe papulopustular rosacea with an Investigator Global Assessment (IGA) score = 4 (See section 7.1.1) at Baseline visit,
•3. The subject has at least 25 inflammatory facial rosacea lesions (papules and pustules) at Baseline visit,
•4. The subject has a body weight between 45 and 100 Kg at Screening visit,
•5. The subject has a Body Mass Index (BMI) between 18 and 30Kg/m2 at Screening visit,
•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 other dermatoses that may be confounded with papulopustular rosacea, such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis at Screening visit,
•2. The subject has a known coagulation disorder or is treated with anticoagulants at Screening or Baseline visits
•3. The subject has any clinically significant blood abnormality (haematology or biochemistry) which might interfere with the pharmacokinetic assessments or would put the subject at risk at Baseline visit.

发起方

GALDERMA R&D SNC