An open-label, single arm non-comparative study to assess effectiveness and safety of Minichek (Minoxidil 5% ) in the management of Androgenic Alopecia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Effects of Minichek 5% treatment on change in Anagen/Telogen ratio with
研究概览
简要总结
Purpose:
Many factors cause clinical hair-loss, or alopecia, including endocrine abnormalities, genetic predisposition, systemic illness, drugs, psychological abnormalities, diet, trauma, infections, autoimmunity, and structural hair defects. Because of the multiplicity of disorders that can result in hair-loss, a thorough history and physical examination are necessary. The causes of androgenic alopecia are well known and easily distinguishable. The primary treatment of hair-loss is still dependent on Minoxidil and Finasteride. No new mainline treatments are available for treatment of hair-loss. Majority of existing Minoxidil preparations are usually solutions with a high percentage of ethyl alcohol. However repeated applications of high ethyl alcohol products lead to severe adverse effects (e.g., scalp dryness, irritation, burning, redness, allergic contact dermatitis Recently ethyl alcohol-free containing formulations have been introduced. However, there is ascarcity of published data on this kind of formulations. So, the current study is to check theeffects of Minichek (Minoxidil 5%) on anagen/telogen ratio and assess the change in severity of hair-loss in patients diagnosed with androgenic alopecia.
Background:
Androgenic Alopecia is one of the common chronic problems seen by dermatologists worldwide. Androgenetic alopecia is a common dermatological condition, with potentially adverse psychosocial sequelae. Androgenetic alopecia (male pattern hair-loss) occurs in men with an inherited sensitivity to the effects of androgens on scalp hair. It is marked by visible loss of hair in areas of the scalp caused by progressive miniaturization of hair follicles.Currently, there are two FDA approved treatment options for AGA, topical minoxidil and oral finasteride. The exact mechanism of action of Minoxidil is uncertain, but it has been suggested that it promotes hair growth by opening adenosine triphosphate-sensitive potassium channels and stimulating the synthesis of vascular endothelial growth factor in dermal papilla cells. Despite of availability of treatment options, clinical trial data proving hair growth efficacy is limited. Therefore, the current investigator-initiated study is being conducted to understand the clinical efficacy of Minichek (Minoxidil 5%) in the treatment of androgenic alopecia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male patients who are ≥18 to ≤45 years of age.
- •Patient suffering from Androgenic alopecia.
- •Patient willing to sign an informed consent form.
排除标准
- •Patient suffering from non-androgenic alopecia.
- •Evidence of dermatological disease as revealed by history, physical examination or laboratory assessment which may interfere with administration or assessment of study medication.
- •Current use of dermatological drugs/preparations which may interfere with study evaluation (Finasteride or any other hormonal treatment).
- •Intolerance to any of the ingredients of the formulation.
- •Current alcohol or drug abuse.
- •Patients viewed by the investigator as not being able to complete the study.
- •Patients having participated in a clinical trial in last 30 days.
- •Patients with a history of a migraine.
结局指标
主要结局
Effects of Minichek 5% treatment on change in Anagen/Telogen ratio with
时间窗: From baseline to day 45, day 90, day 135 and day 180.
androgenetic alopecia.
时间窗: From baseline to day 45, day 90, day 135 and day 180.
次要结局
- Investigator and Patient’s global assessment for tolerability.(At day 45, day 90, day 135 and day 180.)
- Effects of Minichek 5% treatment on change in Hair diameter.(From Baseline to day 45, day 90, day 135 and day 180.)
- Investigator and Patient’s global assessment for effectiveness.(At day 90 and day 180 on the basis of global photographs.)
- Trichoscopy Evaluations of the Minichek 5% treatment at day 45, day 90, day 135 and day 180.(At day 45, day 90, day 135 and day 180.)
- Safety assessment of the Minichek 5% in the treatment of AGA.(At day 45, day 90, day 135 and day 180.)