EUCTR2014-001491-62-SK进行中（未招募）1 期
Clinical efficacy and safety of NAI-Acne gel 3% applied twice-a-day to patients with facial acne vulgaris - NAI-003 3% gel efficacy pilot
AICONS Srl.0 个研究点开始时间: 2014年7月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- Male
入选标准
- •1.Informed consent: signed written informed consent before inclusion in the study
- •2.Sex and Age: men aged 18-50 years old inclusive
- •3.Diagnosis: moderate to severe facial acne with an IGA of 3-4 at screening and at baseline
- •4.Cutaneous lesions: 15=inflammatory lesions=70 located at or above the jawline
- •5.Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
- •6.Contraception: willingness to use a barrier form of contraceptive with spermicidal foam/gel/film/cream/suppository throughout the study.
- •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 90
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Face skin conditions: face skin lesions other than acne lesions or local conditions preventing a correct evaluation of acne lesions (e.g. beard)
- •2.Nodulocystic acne: significant nodulocystic acne on the face i.e. =4 facial nodules defined as inflammatory lesions =0.5 cm in diameter and/or =1 facial cystic lesions defined as larger nodules undergoing suppuration
- •3.Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness; presence of abnormalities including alanine aminotransferase (ALT), aspartate aminotransferase (AST), ?-glutamyl transferase (?-GT), creatinine, urea and/or glucose values above 2x upper limit of normality (ULN) of the laboratory performing the analysis
- •4.Allergy: ascertained or presumptive hypersensitivity to antibiotics and/or to the test formulations' ingredients
- •5.Diseases: underlying severe renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin (excluding facial acne vulgaris), haematological, endocrine or neurological diseases including severe infections and viral diseases that may interfere with the aim of the study
- •6.Medications: systemic antibiotics, acne medications and/or light therapies in the month preceding the screening; topical antibiotics, antiseptics and/or acne medications in 2 weeks preceding the screening; continuous concurrent use of topical and/or systemic medications acting on or influencing acne
- •7.Investigative drug studies: participation in the evaluation of any investigational product within 30 days of the screening
- •8.Exposure to sun: inability and/or unwillingness to avoid excessive natural or artifical exposure to UV rays during the whole study duration
研究者
相似试验
进行中（未招募）
不适用
An assessment of the safety and efficacy of the Acne Scar Treatment Pen to treat facial acne scarsISRCTN18051758Medical Brands B.V.66
已完成
2 期
Clinical study on Anti-acne face pack in pimplesCTRI/2022/07/044012amaskar Ayurved Private Limited32
招募中
不适用
Evaluation of the Efficacy and Safety of Topical Adiponectin Peptides on Hair Growth and Preventing Hair LossKCT0003559Seoul National University Hospital60
已完成
2 期
Clinical study on Anti-acne spot oil in pimplesCTRI/2022/07/044013amaskar Ayurved Private Limited30
已完成
2 期
Alpha ointment (Henna) and hydrocortisone in radiation-induced dermatitisseverity of radiation - induced skin reaction.L58.0, L58RadiodermatitisIRCT201206099979N1Vice chancellor for research,, Shiraz University of Medical Sciences60