CTRI/2009/091/000791已完成3 期
Double-blind, randomized, placebo-controlled, multicentric study to prove the therapeutic efficacy and tolerability of Ichthraletten® versus placebo in case of mild to moderate Acne papulopustulosa. - KF 01/09
ICHTHYOLCompany Cordes Hermanni and Co0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 a legal representative
- •>Diagnosis: mild to moderate acne papulopustulosa in the area of the face, level 2 ? 3 referring to GAAS.
- •>Safe contraception
排除标准
- •>Acne resulting from medicine , steroid acne, halogen acne, acne-like dermatitis
- •>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
- •>Fructose-intolerance, lactase-deficiency, saccharase-isomaltase-deficiency, glucose-galactose-malabsorption
- •>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 3 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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