EUCTR2009-013273-17-DE进行中（未招募）1 期
Double-blind, randomized, vehicle-controlled, multi-centric trial to prove the therapeutic efficacy and tolerability of a liquid acne topical containing Clindamycin phosphate and Sodiumbituminosulfonate, pale versus vehicle and versus each of the single active substances in mild to moderate acne vulgaris - liquid acne topical in mild to moderate acne vulgaris
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •·Male or female patients between 10 and 45 years
- •·Voluntary participation in the study
- •·Availability of signed consent form of patients, in case of patients < 18 years in addition with the signature of both legal representatives
- •·Diagnosis: mild to moderate acne vulgaris in the area of the face, level 2 – 3 referring to GAAS
- •·Safe contraception (female patients)
- •Are the trial subjects under 18? yes
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Acne resulting from medicine , steroid acne, halogen acne, acne-like dermatitis
- •·Serious form of acne (for example acne conglobata)
- •·Serious supplementary diseases (e.g. liver-/renal function disturbances, metabolic diseases, tumours in anamnesis)
- •·Existence of an disease that demands systemic and/or topical antibiotics- or steroid-administration
- •·Systemic pre-treatment with isotretinoin
- •·Oral and/or topical therapy with antibiotics, anti-androgens (apart from safe contraception), corticosteroids, retinoids, azelaic acid, salicylic acid or benzoyl peroxide before or during the study (previous topical therapy must end at least 2 weeks before admission to the study and an oral therapy at least 4 weeks before admission to the study!)
- •·Application of other medicinal products which can affect the course of disease or the therapy during the study
- •·Application of any cosmetic products in the face during the study period
- •·Known allergy towards substances of investigational medicinal product
- •·Alcohol-, drugs- or medication abuse
- •·Physical or psychological diseases in case of which the adherence of study protocol appears to be doubtful
- •·Inadequate compliance
- •·Pregnancy, lactation
- •·First time application of hormonal contraceptives or change of contraceptives within the last 6 months
- •·Participation in a clinical study within the last 30 days, planned participation in a clinical study during the course of this study
- •·Previous participation in this study
- •·Participation of another family member in this study
- •·Pre-treatment with the study medication
研究者
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