Comparison of Outcomes Between Topical Minoxidil Versus Oral Minoxidil for the Treatment of Androgenetic Alopecia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Efficacy of drug
研究概览
简要总结
To compare the outcome of topical minoxidil 5% spray versus oral minoxidil 2.5 mg tablet for the treatment of androgenetic alopecia in males and females. Outcomes include efficacy of the treatment, measured by reduction in hair shedding, improvement in hair density and new hair growth as assessed by physican and patient assessment as well as safety, defined as incidence and severity of adverse events over a treatment period of 6 months
详细描述
This cohort, adaptive, randomized, double armed group, controlled, investigator-initiated interventional study is designed to demonstrate the superiority of a combination of Topical minoxidil vs oral minoxidil in patients suffering from androgenetic alopecia who consent to randomization following a new diagnosis in Pakistan.
Conditions Androgenetic Alopecia
Intervention/Treatment:
Drug: Oral Minoxidil Drug: Topical Minoxidil
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with androgenic alopecia Norwood-Hamilton class 2-6 in males and Sinclair class 2-5 in females
- •History of androgentic alopecia for at least 1 year
- •18 to 50 years of age
- •Willing to provide informed consent
- •Willing to not use any other hair loss treatment during the treatment period
排除标准
- •History of cardiovascular disease
- •Use of some other hair restoration therapy in the past 6 months such as minoxidil, finasteride or PRP
- •Presence of other causes of alopecia (e.g., alopecia areata, scarring alopecia).
- •Pregnant and lactating females
- •Previous Hair Transplantation
- •Patients with a known hypersensitivity to the study drug or class of study drug
- •Patients with co-morbid conditions like chronic liver disease, chronic kidney disease, neurological or psychiatric disorders
- •Presence of any other autoimmune disease (especially thyroid disease)
研究组 & 干预措施
Minoxidil Tablet Arm
Mixidil tablet placebo spray
干预措施: Placebo Spray (Drug)
Minoxidil Tablet + Spray Arm
Minoxidil spray Minoxidil Tablet
干预措施: Minoxidil 5 % Topical Spray (Drug)
Minoxidil Tablet + Spray Arm
Minoxidil spray Minoxidil Tablet
干预措施: minoxidil (Drug)
Disease Control
Placebo spray and palcebo tablet
干预措施: Placebo Tablet or Capsule (Drug)
Minoxidil Spray Arm
Placebo tablet Mixidil spray
干预措施: Minoxidil 5 % Topical Spray (Drug)
Minoxidil Spray Arm
Placebo tablet Mixidil spray
干预措施: Placebo Tablet or Capsule (Drug)
Minoxidil Tablet Arm
Mixidil tablet placebo spray
干预措施: minoxidil (Drug)
Disease Control
Placebo spray and palcebo tablet
干预措施: Placebo Spray (Drug)
结局指标
主要结局
Efficacy of drug
时间窗: 6 months
The effectiveness of the treatment in terms of reduction in hair shedding, improvement in hair density, and new hair growth will be measured by a standardised seven point scale for physician photographic assessment and patient self assessment.
Physician Photographic Assessment Scale
时间窗: 6 months
(+3 = Excellent Improvement, +2 = moderately improvement , +1 = mild improvement, 0 = no change, -1 = mild worsening, -2 =moderate worsening, -3 = severe worsening)
Patient Satisfaction Scale
时间窗: 6 months
-3 Very Unsatisfied, -2 Moderately Unsatisfied, -1 Slightly Unsatisfied, 0 No Change, 1 Slightly Satisfied, 2 Moderately Satisfied, 3 Very Satisfied
次要结局
- Drug Safety(6 months)
- Severity of adverse effect (mild, moderate, severe)(6 months)
研究者
Sohaib Ashraf
Consultant Cardiologist
Sheikh Zayed Federal Postgraduate Medical Institute