CTRI/2012/02/002456已完成2 期
Open Label Phase II study to evaluate the Safety and Efficacy of topical application of study drug for the treatment of mild to moderate Androgenic Alopecia in Male Patients
Kumar Organic products Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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
- •Men aged 25 to 45 years, in general good health
- •-Mild to moderate male-pattern baldness (androgenic alopecia), preferably on the top back of the skull.
- •-Willingness to maintain the same hair style, approximate length, and hair color throughout the study
- •-Subject willing to continue his current regimen of vitamins and nutritional
- •supplements and not start any new vitamins or nutritional supplements for the
- •duration of the study.
- •- Able to read, understand, and provide written (signed) informed consent after the
- •nature of the study has been fully explained and before any procedures dictated by
- •this protocol were performed.
- •- Subjects must be willing and able to comply with follow-up requirements in a timely manner.
排除标准
- •Any dermatological condition of the scalp other than androgenic alopecia (males)
- •-Prior use of scalp hair growth treatment (e.g., finasteride, minoxidil) within 6 months
- •-Any prior hair growth procedures (e.g., hair transplant or laser)
- •-History of alcohol or drug addiction
- •-History of skin allergy
- •-Regular use of medication which might interfere with the results of the study
- •- Subject had used phytotherapy (e.g., saw palmetto) within eight weeks prior to
- •-Any active skin infection in the scalp area or scarring in the target area.
- •-Photosensitivity to laser light.
- •- Subject had used Accutane® in the previous year. ( Isotretinoin (sold as Accutane or roaccutane) Isotretinoin is an isomer of Vitamin A (13-cis-Vitamin A acid). Hair thinning or hair loss on the other hand, is one of the most commonly reported post accutane side effects.
- •-Medications with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, bicalutamide), topical estrogen, tamoxifen, anabolic steroids, oral glucocorticoids (or other medications at the discretion of the Investigator.(these are the Medications for hairloss)
- •-History of thyroid or other medical condition that might influence hair growth and
- •loss, at the discretion of the Investigator.
- •- Subject had â??buzzâ?? cut hairstyle, defined as hair cut to less than one inch in
- •- Subject had light blonde hair, at the discretion of the investigator.
- •- Subject had ever received radiation therapy to the scalp, or had chemotherapy
- •within the past year.
- •- Subject had participated in any investigational study within the 30 days prior to
- •randomization.
- •-A history or the presence of any serious and/or chronic medical condition(s)
- •[including psychiatric illnesses] which, in the opinion of the investigator, may
- •cause harm to the individual and/or compromise/confound the study results.
- •Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s).
- •Subjects unwilling or unable to comply with the study procedures
研究者
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