Role of platelet rich plasma (PRP) in the treatment of male type baldness
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Hamilton Norwood grading
研究概览
简要总结
Androgenetic alopecia (AGA) is a common chronic hair loss disorder. It is characterized by progressive hair loss, affecting both sexes. AGA is considered to be the most common type of baldness characterized by progressive hair loss.
PRP has also attracted attention in plastic surgery and dermatology because of its potential use during facial plastic surgery and aesthetic, skin-rejuvenating effects and in hair loss. PRP is a new method as seen in previous studies PRP seems to be a promising new technique may improve hair regrowth, thereby making the PRP procedure an alternative to finasteride or minoxidil.
Study design: a randomized, double-blind controlled trial, four groups study.
Four different groups are:
1. Patient was given minoxidil solution 5% topically 1ml over whole scalp two times a day throughout the study period with intralesional(placebo) injection of Normal saline 0.9% monthly for 3 months.
2. Patients was given minoxidil solution 5% topically 1ml over whole scalp two times a day throughout the study period with intralesional injection of PRP monthly for 3 months.
3. Patient was given topical placebo containing (58ml of Normal saline 0.9% and 2 ml spirit) topically 1ml over whole scalp two times a day throughout the study period with intralesional(placebo) injection of Normal saline 0.9% monthly for 3 months
Patient was given topical placebo containing (58ml of Normal saline 0.9% and 2 ml spirit) topically 1ml over whole scalp two times a day throughout the study period with intralesional injection of PRP monthly for 3 months.
Patient randomization was done using website www.radomizer.org.
All four groups will be compare for efficacy, adverse effect monthly for 5 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.All the patients not using topical minoxidil and finasteride for at least 6 months will be considered for PRP therapy.
- •2.Age group 20 – 60 years 3.Sex- Male 4.Mild to moderate AGA (Hamilton-Norwood score II-V) .
- •5.Patients willing to come for follow up every month for 5 months.
排除标准
- •1.Patients not giving informed written consent, unable to understand the protocol and uncooperative patients.
- •2.Any inflammation, erythema or scarring over scalp except mild seborrheic dermatitis.
- •3.Patients who have history of malignancies, platelets disorders or bleeding disorders, anemia ( haemoglobulin of less than 10 gm/dl), bone marrow aplasia, diabetes, sepsis, and cancer.
- •4.Patients taking theses any of these medications- i.Anti-coagulants – heparin, warfarin ii.Anti-hypertensives – beta-blockers, ACE inhibitors hormones iii.Anticonvulsants – valproic acid, carbamazepine, phenytoin, mood stabilizers Antidepressants, lithium iv.Aspirin or any non-steroidal anti-inflammatory drugs two week prior to procedure.
- •v.Other medications cimetidine, retinoids (acitretin > isotretinoin), antithyroid drugs, cholesterol lowering drugs, interferons, amphetamines, bromocriptine, levodopa, some antipsychotic and anti-anxiety drugs, rarely tricyclic antidepressants such as amitriptyline 5.Patients who are known to be HIV, hepatitis B or C positive or otherwise immunocompromised.
- •6.Patients with a propensity for keloids 7.Patients on antiplatelet drugs like aspirin or non-steroidal anti-inflammatory drugs.
结局指标
主要结局
Hamilton Norwood grading
时间窗: every month for 5 months
Hair density
时间窗: every month for 5 months
Patient self assessment
时间窗: every month for 5 months
次要结局
- Age(sex)