A Double Blind, Randomized, Efficacy And Tolerability Comparison Study of Topical Solution of Bimatoprost (1 percent) and Levocetirizine (1 percent) versus Minoxidil (5 percent) Topical Solution for the Treatment Of Androgenic Alopecia (AGA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change from baseline to end of the treatment in target area hair count (by dermatoscope
研究概览
简要总结
This is a double-blind, randomized clinical trial designed to compare the efficacy and tolerability of a novel combination topical formulation PDFE-2304, versus Minoxidil 5 percent in the treatment of Androgenic Alopecia (AGA). A total of 15 male subjects with AGA will be enrolled and randomized in a ratio of 10 subjects receiving the test product (PDFE-2304) and 5 receiving the comparator (Minoxidil 5 percent). Each participant will attend five clinic visits over the course of the study.
The investigational product (PDFE-2304) is hypothesized to act on a dual mechanism to stimulate hair growth by shifting the hair cycle from telogen to anagen.
Objectives:
Primary Objective is to assess the efficacy and tolerability of PDFE-2304 compared with Minoxidil 5 percent in treating AGA, using target area hair count as the primary endpoint (measured by dermatoscope photography).
Secondary Objectives is to assess Subject Self-Assessment (SSA) Score, Investigator Global Assessment (IGA) Score, Target Area Hair Width (TAHW), Target Area Hair Darkness (TAHD), Global Panel Review (GPR) Score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Men who have a presentation of androgenetic alopecia (Norwood II.
- •Age between 18 to 60 years of age (both inclusive).
- •Have no abnormal findings during physical examination.
- •Able to comply with the study procedures in the opinion of the PI/CI.
- •Able to give written consent for participation in the study.
排除标准
- •Known hypersensitivity or idiosyncratic reaction to study formulation.
- •Clinical diagnosis of non-AGA forms of alopecia.
- •History of hair transplants.
- •Subject having dyed or bleached hair 12 months prior to study start.
- •Use of any topical product in the target region in the last 6 months.
- •A medical history of receiving chemotherapy/cytotoxic agents.
- •Uncontrolled hypertension.
- •Hormonal diseases such as thyroid disorders or diabetes.
- •Liver and kidney disease.
- •Drug or alcohol abuse within 12 months.
- •No written consent.
- •The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study drug.
结局指标
主要结局
Change from baseline to end of the treatment in target area hair count (by dermatoscope
时间窗: Baseline, Week 16 (Day 112)
photo).
时间窗: Baseline, Week 16 (Day 112)
次要结局
- Change from baseline to Day 56 target area hair count (by dermatoscope photo)(Baseline, Week 8 (Day 56))
- Comparison of Subject Self-Assessment in Alopecia (SSA) Score between test product and(comparator.)
- Target Area Hair Width (from overview photo), Target Area Hair Darkness (from overview photo)(Week 16 (Day 112))
- Comparison of Investigator Global Assessment (IGA) Score between test product and comparator.(Week 16 (Day 112))
- Global Panel Review (from overview photo)(Week 16 (Day 112))
- Subject health, well-being & vitals (Blood pressure, radial pulse, respiratory rate and body temperature) will be monitored and assessed at all visits(Day 1, Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84) & Week 16 (Day 112))
研究者
Dr Shivaprasad Kumbar
Koppal Institute of Medical Sciences