Effect of Minoxidil Solution Iontophoresis on Androgenic Alopecia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in the number of hair follicles
研究概览
简要总结
The aim of the study is to evaluate the therapeutic efficiency of minoxidil solution iontophoresis on Androgenic Alopecia.
详细描述
Hair is an important component of identity and self-image. Hair loss can lead to a variety of psychological difficulties and have a negative impact on quality of life (QoL). Loss of self-confidence lowered self-esteem, and heightened self-consciousness are common responses to hair loss, particularly for women. People with alopecia are more likely to develop depression and anxiety.
Some studies have proposed iontophoresis and ultrasound as energetic drug delivery methods to favor topical therapy of alopecia. Iontophoresis is a non-invasive technique that applies a small electric current (of no more than 0.5 mA/cm2) on the skin's surface to increase and control drug delivery. The technique is widely studied to stimulate the skin penetration and permeation of hydrophilic drugs, which would not be absorbed by the skin when passively applied. The transport of drugs through the skin as a result of the electric current is driven by two different mechanisms, ie, electromigration in the case of charged drugs and electroosmosis in the case of neutral drugs.
Furthermore the need of this study is developed from the lack in quantitative knowledge and information in published studies which investigate effect of minoxidil solution iontophoresis on Androgenic alopecia.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Twenty-five adult aged 18-65 with diagnosed androgenic alopecia.
- •They diagnosed as Androgenic alopeacia by their physicians and referred for physical therapy management.
- •Medically and psychologically stable patients.
排除标准
- •History of hypersensitivity to minoxidil solution or Intophoresis.
- •Scalp infection
- •Concurrent hair loss treatments.
- •Patients who suffer from hypertrophic and/or keloidal scars and a skin condition in the area of Androgenic alopecia that would interfere with study procedures.
- •plaque psoriasis, tattoo, birthmark, facial hair.
- •Patients with medical red flags as severe psychiatric disorder or cognitive deficits.
- •Medically unstable and uncooperative patients.
- •Immunocompromised status.
- •History of skin cancer.
- •Recurrent herpes viral infection.
- •Pregnancy or breastfeeding status.
研究组 & 干预措施
Minoxidil-treated scalp
5% minoxidil through iontophoresis will be applied to one half of the scalp twice daily at home.
干预措施: Minoxidil solution iontophoresis (Other)
Saline-treated scalp
The other half of the scalp will receive a placebo solution, (eg saline) with current application.
干预措施: saline solution iontophoresis (Other)
结局指标
主要结局
Change in the number of hair follicles
时间窗: 12 weeks
Trichoscopy will be used to detect the change in the number of hair follicles as a comparison between before and after intervention. Trichoscopy helped with the definitive diagnosis of Alopeacia in patients for whom the clinical diagnosis was doubtful, which was confirmed by histopathology. Thus trichoscopy is a noninvasive, sensitive and specific investigation that is valuable in women with alopecia, the cause of which is otherwise very difficult to assess clinically, and it has a definite role in the diagnosis of cases with an atypical clinical picture.Trichoscopy results were obtained in frontal, occipital and both temporal areas of scalp, including number of yellow dots and vellus hairs, number of hairs in one pilosebaceous unit and percentage of follicular ostia with perifollicular hyperpigmentation.
Change in the number of hair follicles
时间窗: 12 weeks
Trichoscopy will be used to detect the change in the number of hair follicles as a comparison between before and after intervention. Trichoscopy helped with the definitive diagnosis of Alopeacia in patients for whom the clinical diagnosis was doubtful, which was confirmed by histopathology. Thus trichoscopy is a noninvasive, sensitive and specific investigation that is valuable in women with alopecia, the cause of which is otherwise very difficult to assess clinically, and it has a definite role in the diagnosis of cases with an atypical clinical picture.Trichoscopy results were obtained in frontal, occipital and both temporal areas of scalp, including number of yellow dots and vellus hairs, number of hairs in one pilosebaceous unit and percentage of follicular ostia with perifollicular hyperpigmentation.
次要结局
- Change of hair thickness(12 weeks)
- Change of hair thickness(12 weeks)
研究者
Mahmoud Ibrahim Mohammed Ahmed
Principal investigator
Cairo University