COMPARISON OF EFFICACY OF TOPICAL FINESTERIDE VERSUS TOPICAL MINOXIDAL IN TREATMENT OF ANDROGENETIC ALOPECIA
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- COMPARISON OF EFFICACY OF TOPICAL FINESTERIDE VERSUS TOPICAL MINOXIDAL IN TREATMENT OF ANDROGENETIC ALOPECIA
研究概览
简要总结
Androgenetic alopecia (AGA)is the most common form of alopecia. It predominantly affects males, but there has been a significant surge in female preponderance too, over the last decade Minoxidil belong to the anti-hypertensive class but it also affects the potassium channels present in vascular smooth muscles and hair follicles. This potassium channel activity may stimulate the microcirculation around the hair follicles and induces arteriolar vasodilation, thereby encouraging conditions conducive to hair growth Topical administration of finasteride offers the potential to reduce systemic effects related to its mechanism of action by preferentially inhibiting 5-a reductase in the scalp, as has been suggested in recent years so in this study we are going to compare efficacy of topical minoxidil versus topical finasteride in treatment of androgenetic alopecia
详细描述
Androgenetic alopecia (AGA)is considered to be a very common form of alopecia. Minoxidil belong to the anti-hypertensive class but it also affects the potassium channels present in vascular smooth muscles and hair follicles. This potassium channel activity may stimulate the microcirculation around the hair follicles and induces arteriolar vasodilation, thereby encouraging conditions conducive to hair growth The clinical efficacy of oral finasteride for treating AGA is well established. Although oral finasteride is generally well tolerated Topical finasteride is a medication that is used to treat hair loss in men and women. It is a topical version of the oral medication finasteride, which works by blocking the conversion of testosterone to dihydrotestosterone (DHT), a hormone that contributes to hair loss. Topical administration of finasteride offers the potential to reduce systemic effects related to its mechanism of action by preferentially inhibiting 5-a reductase in the scalp, as has been suggested in recent years.
OBJECTIVE "To compare the efficacy of topical finasteride vs topical minoxidil in the treatment of androgenetic alopecia in tertiary care hospital"
DATA COLLECTION:
Data will be collected on prescribed proforma which is attached, at Dermatology OPD, Sheikh Zayed Hospital, Rahim Yar Khan. Patient will be selected on basis of inclusion & exclusion criteria. Informed consent will be taken from selected patients before data collection. Study will include 190 patients which will be divided into 2 groups A & B, 95 in each group. Group A will receive topical finasteride spray 0.25% twice daily for 12 weeks. Group B will receive topical 5% minoxidil twice daily for 12 weeks Patient will be followed at the end of 12 weeks therapy.
DATA ANALYSIS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age: 20-50 years
- •Gender: Male
- •ANDROGENETIC ALOPECIA with AGA stage 2-6 Norwood-Hamilton -classification
- •Patients not taking any treatment in last 1 month
排除标准
- •Abrasion or abnormalities to the scalp
- •Hair transplant
- •Hypersensitivity
- •Recent history of local infections of the head
- •History of relevant significant disease active seborrheic dermatitis
- •Concurrent use of :
- •corticosteroids
- •anabolic steroids or over-the-counter 'hair restorers'
- •use of drugs with anti-androgenic properties within 6 months light or laser treatment of the scalp within the last 3 months.
研究组 & 干预措施
Finesteride group
Group A will receive topical finasteride spray 0.25% twice daily for 12 weeks
干预措施: topical finasteride (Drug)
Minoxidil group
Group B will receive topical 5% minoxidil twice daily for 12 weeks
干预措施: Topical minoxidil (Drug)
结局指标
主要结局
COMPARISON OF EFFICACY OF TOPICAL FINESTERIDE VERSUS TOPICAL MINOXIDAL IN TREATMENT OF ANDROGENETIC ALOPECIA
时间窗: Clinical assessment for efficacy will be done monthly for 6 months
The final efficacy will be divided into following groups on the basis of Norwood-Hamilton scale from the baseline :1.Excellent efficacy: It is defined as greater than two scale change in hair density as measured from baseline . 2. moderate efficacy : It is defined as one to two scale change in hair density as measured from baseline. Percentage increase in hair density as clinically measured by the surface area from the baseline. 3.Non efficacious: It is defined as less than one scale change in hair density as measured clinically from baseline.
次要结局
未报告次要终点
研究者
Farah Humera
Post Graduate Resident in Dermatology
Sheikh Zayed Medical College