Topical Cetirizine Gel Versus Minoxidil 5% Gel in Treatment of Androgenetic Alopecia
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of the hair density (follicles/cm²)
研究概览
简要总结
Androgenetic alopecia (AGA), also known as androgenic alopecia or male pattern baldness, is the most common type of progressive hair loss. It is a polygenetic condition with variable degree of severity, age of onset, and location of hair loss.
Male AGA (MAGA) is clearly an androgen-dependent condition and, although the mode of inheritance is uncertain, a genetic predisposition is observed.
Regarding treatment of AGA; in most cases it's challenging and unsatisfactory. Finasteride and Minoxidil 2-5 % solution are the only US Food and Drug Administration (FDA) approved treatment options for MAGA.
On the basis of hypertrichosis observed in patients treated with analogues of prostaglandin PGF2a (i.e. latanoprost used for glaucoma), it was supposed that prostaglandins would have an important role in the hair growth (Nieves et al., 2014).
Multiple studies had claimed that prostaglandins are deregulated in both alopecia areata (AA) and AGA.
Cetirizine, is a safe and selective second-generation histamine H1 receptor antagonist widely used. It has anti-inflammatory properties. Studies have shown cetirizine causes a significant reduction in both the inflammatory cell infiltrate and PGD2 production.
The oral administration of cetirizine is commonly leads to different systemic side effects. Thus the topical formulation is expected to be an effective tool for avoiding the oral side effects as well as better targeting, but unfortunately, no topical formulation of cetirizine is available in the market till date.
详细描述
Androgenetic alopecia (AGA), also known as androgenic alopecia or male pattern baldness, is the most common type of progressive hair loss. It is a polygenetic condition with variable degree of severity, age of onset, and location of hair loss.
Hair loss typically begins with bi-temporal recession of the frontal hairline, followed by diffuse hair thinning at the vertex, and eventual complete loss of hair at the center of the vertex. The bald patch at the vertex subsequently joins the frontal receding hairline, leaving an island of hair on the frontal scalp, which finally disappears leaving hair only in the parietal and occipital zones producing the characteristic "horseshoe" pattern.
Androgenetic alopecia is classified according to the Hamilton-Norwood scale into grades (from I to VII).
AGA features a progressive miniaturization of the hair follicle leading to vellus transformation of terminal hair which results from an alteration in hair cycle dynamics: anagen phase duration gradually decreases and that of the telogen phase increases. As the anagen phase duration determines hair length, the new anagen hair becomes shorter, eventually leading to bald appearance.
The etiology of AGA is multifactorial and polygenetic. Male AGA (MAGA) is clearly an androgen-dependent condition and, although the mode of inheritance is uncertain, a genetic predisposition is observed, while in female AGA (FAGA) the role of androgens is still uncertain.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The patients will be randomly divided into 2 groups; each group contains 30 patients. Patients in both groups will be given the treatment in identical non-labeled bottles with a code and neither the patient nor the doctor will know which treatment is given and what the code referred to. The patients will be instructed to use the treatment twice daily for 6 month duration.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Only males with Androgenetic Alopecia.
- •Age (18 - 50) years.
- •AGA grade II to VII according to Norwood-Hamilton classification
排除标准
- •Females with Androgentic Alopecia.
- •Previous history of sensitivity to Cetirizine.
- •Previous treatment for AGA in the last in the last 3 months
- •Chronic Systemic diseases as; hypotension, cardiac patients, renal failure or liver failure.
研究组 & 干预措施
Study group
Group of 30 patients randomly selected will use topical Cetirizine 1% gel twice daily over a period of 6 months, where the treatment will be given in identical non-labeled bottles with a code and neither the patients, healthcare provider nor the investigator will know which treatment is given and what the code referred to.
干预措施: Cetirizine (Drug)
Control group
Group of 30 patients randomly selected will use topical Minoxil 5% gel twice daily over a period of 6 months, where the treatment will be given in identical non-labeled bottles with a code and neither the patients, healthcare provider nor the investigator will know which treatment is given and what the code referred to.
干预措施: Minoxidil (Drug)
结局指标
主要结局
Change of the hair density (follicles/cm²)
时间窗: 6 months
Improvement of the outcomes of treatment of androgenetic alopecia with Cetirizine 1% gel in comparison to Minoxidil 5% gel in terms of proportion of hair regrowth, the hair density (follicles/cm²) .
次要结局
- Change of the hair diameter(6 months)
研究者
Reham Abdalla Ibrahim
Doctor
Assiut University