EFFICACY OF TOPICAL MINOXIDIL ALONEAND TOPICAL MINOXIDIL- PLATELET RICH PLASMA COMBINATION IN WOMEN WITH FEMALE PATTERN HAIR LOSS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Comparative assessment of the proportion of patients with patient satisfaction score more than 6
研究概览
简要总结
Female pattern hair loss (FPHL) refers to a progressive decline in hair fibre production by scalp hair follicles and their eventual miniaturisation. Women who seek medical advice for their hair loss experience more negative body image feelings, more social anxiety and poorer self esteem and psychosocial well being than control subjects with non visible skin disease, as well as dissatisfaction with their hair. Platelet-rich plasma (PRP) is a treatment modality that has gained popularity for FPHL over the years due to its autologous nature, minimal invasiveness, absence of major side effects, better compliance and more affordable cost compared with hair restoration surgery. PRP is an autologous preparation of platelets in concentrated plasma (usually N 1,000,000 platelets/μL or 2-7 times the native concentration of whole blood).
This study is a randomised controlled trial to assess the efficacy of minoxidil alone and minoxidil-platelet rich plasma therapy combination in women with female pattern hair loss. The randomisation will be done using computer generated randomization sequence by person not involved in the study. Sealed opaque envelopes containing group codes will be prepared. Envelopes will be sequentially numbered and kept in order according to their serial number. Envelope will be opened at the time of randomization and the patient will be allocated to their respective group.
Autologous PRP suspension (1-3ml) will be injected intradermally (as per the dimensions of the affected area. As a standard protocol which is being followed in the department, 0.1 ml is injected at a distance of 1 cm in the affected area of FPHL in minimum of 4 (monthly) sessions.)
Patient will be instructed to apply 1ml of the minoxidil 2% solution over the affected site twice daily.
Following observations will be made ;
1.Comparative assessment of the proportion of patients with patient satisfaction score of more than 6
Comparative assessment of the following parameters in the two groups.
1.Mean change in hair density from baseline to 6 months
2.Proportion of patients showing improved hair density on global photography.
3.Proportion of patients showing negative hair pull test at the end of 6 months.
4.Percentage of patients showing side effects of PRP therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females aged 18-55 years with a clinical and trichoscopic diagnosis of FPHL.
- •Ludwig score 1-3, all patterns of FPHL.
- •Females giving consent for photography of the scalp.
排除标准
- •Pregnant and lactating females.
- •Known case of polycystic ovarian disorder (PCOD) or presence of clinical signs suggestive of PCOD.
- •H/o oopherectomy, autoimmune or endocrinological disorder (Cushings/Addisons disease), platelet disorders, bleeding disorders, malignancy or keloidal tendency.
- •History of any treatment for hair loss in the past 90 days (oral/topical hair growth boosters/hormonal therapy/anticancer drugs or steroids).
- •Any active scalp infection.
- •Pregnant Patients with positive viral markers (HIV 1 and 2, Hepatitis B & C) or otherwise immunocompromised .
结局指标
主要结局
Comparative assessment of the proportion of patients with patient satisfaction score more than 6
时间窗: at 24 weeks
次要结局
- â–Comparative assessment of the following parameters in the two groups.(1.Mean change in hair density from baseline to 6 months)