A Randomised, Double-Blind, Multicentre, Parallel-Group, Phase III, Clinical Study to Compare Efficacy and Safety of Topical Fixed Dose Combination of Minoxidil (5 percentage w/v) and Finasteride (0.1 percentage w/v) Cutaneous Spray Solution against Regaine® (5 percentage w/v) Cutaneous Spray Solution in Male Subjects with Androgenetic Alopecia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Mean change in hair density (by Trichoscopy)
研究概览
简要总结
This study will be conducted to compare efficacy and safety of topical fixed dose combination of Minoxidil (5% w/v) and Finasteride (0.1% w/v) Cutaneous Spray Solution against Regaine® (5% w/v) Cutaneous Spray Solution in male subjects with androgenetic alopecia. Subjects who meet all inclusion criteria and none of the exclusion criteria based on medical history will be recruited in the study.
The subjects will be randomized in the ratio of 1:1. They will either receive test product Arm 1: Minoxidil + Finasteride/Verisfield cutaneous. Spray solution. [50 mg/ml (5%) Minoxidil + 1 mg/ml (0.1%) Finasteride] or Arm 2: Regaine® (5% w/v) cutaneous solution. Primary end point will be mean change in hair density (by Trichoscopy). Secondary end point will be mean change in the hair diameter (by Trichoscopy), mean change in global photographic assessment score, mean change in stages of scalp baldness, absolute and percentage change in dihydrotestosterone (DHT) levels, difference in number and frequency of adverse events, comparison of proportion of subjects having clinically significant change in laboratory parameters between test group vs reference group and local tolerability assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 41.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male subjects with age between 18 to 41 years old (both inclusive).
- •Subjects must have a clear diagnosis of mild to moderate androgenetic alopecia (Stage II to V of the Norwood-Hamilton classification).
- •Subjects who have used Minoxidil 5% w/v topical solution in the past for at least 6 consecutive months but have responded insufficiently.
- •Subject who have willingness to maintain the same hairstyle, length and hair colour of the scalp throughout the study.
- •Subjects must be willing to provide written informed consent to participate in the study and comply with study procedures throughout study.
排除标准
- •Subjects who are undergoing hair growth or transplant treatment 3 months before screening into the study. 2) Subjects with following comorbidities, if clinically significant:.
- •Concomitant scalp diseases with the possibility of interfering with the clinical study related evaluation methods such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars or scalp atrophy.
- •Severe cardiovascular diseases.
- •Renal diseases.
- •Liver diseases.
- •Neurological disease.
- •Lung disease.
- •Psychiatric disorder.
- •History of hypersensitivity to any ingredients in the solution.
- •clinical findings identified during the clinical examination or laboratory tests that somehow prevent participation in the study 3) Subjects who have received Finasteride in the last 6 months. 4) Subjects who are taking any other medicinal or supplement product that may affect hair growth except topical minoxidil. 5) Subjects with a history of alcohol or drug addiction. 6) Subjects with history of HIV, HBV and HCV. 7) Subjects who are on oral medications or suffering from chronic illness which will compromise the study. 8) Subjects who had treatment of cancer chemotherapy last 6 months before starting study or have a plan of treatment during the study term. 9) Subjects who have active hair loss or history within the past 3 months of hair loss other than androgenic alopecia, including diffuse telogen effluvium, alopecia areata, scarring alopecia. 10) Any severe, acute or chronic medical condition that may lead to hair loss or interfere with the interpretation of trial results. 11) Subjects who have enrolled in any other investigational medication study currently, or within the last 30 days of screening. 12) Current use or history of use of systemic treatment (drugs or dietary supplement) taken for more than 2 consecutive weeks interfering with the study product or evaluations (including but not limited to Beta blockers, Cimetidine, Diazoxide, Isotretinoin, corticosteroids, Vitamin A intake above 10000 IU per day) within past 3 months. 13) Current use or history of use of local treatment (drug or cosmetically) on scalp interfering with the study product or evaluation (topical corticosteroids, hair growth formulation, medicated shampoos, topical estrogen, topical Ketoconazole) within past 4 weeks.
结局指标
主要结局
Mean change in hair density (by Trichoscopy)
时间窗: Baseline and week 24
次要结局
- Mean change in the hair diameter (by Trichoscopy)(Baseline and week 24)
- Mean change in global photographic assessment score (GPAS)(Baseline and week 24)
- Mean change in stages of scalp baldness (by Norwood-Hamilton(classification))
- Absolute and percentage change in dihydrotestosterone (DHT)(levels.)
- Difference in number and frequency of adverse events(Till week 24)
- Comparison of proportion of subjects having clinically significant change in laboratory parameters between test group vs reference group
- Local tolerability assessment(At week 8, week 16 and week 24)
研究者
Dr Milan Satia
Ethicare Clinical Trial Services (OPC) Pvt. Ltd.