Photobiomodulated Platelet-Rich Plasma for Androgenetic Alopecia: A Randomized Controlled Trial Comparing Standard PRP vs Red-Light Enhanced vs Blue-Light Enhanced PRP Using the MetaCell Technologies System
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Hair rate Terminal/Vellus (%)
研究概览
简要总结
The goal of this clinical trial is to compare 3 different types of PRP in androgenetic alopecia patients. The main questions it aims to answer:
Does Redlight enhanced, Blue light enhanced, or traditional PRP result in higher hair density and health? Does Redlight enhanced, Blue light enhanced, or traditional PRP result in other improved hair metrics.
Participants will consent to a PRP treatment but will be blinded to the type. They will then be asked to return for Tricholab analysis at set post-operative timepoints to record changes in hair metrics (Baseline, 1 month, 3 months, 6 months, 9 months, 12 months).
详细描述
This study will use written standard operating procedures SOPs to standardize PRP preparation as per MCT System instructions, injection technique, photobiomodulation device operation, and outcome assessment across all participants and all three treatment arms. Following confirmation of eligibility and informed consent, participants will be randomized in a 1:1:1 ratio to one of three parallel arms: standard PRP alone, red-light enhanced PRP with adjunctive cooling, or blue-light enhanced PRP with exosome protocol. Randomization will use a computer-generated block randomization sequence, generated centrally by a study team member independent of recruitment and outcome assessment. Allocation will be concealed using sequentially numbered, sealed, opaque envelopes, opened only after a participant's eligibility has been confirmed and consent obtained, in order to prevent selection bias in group assignment.
PRP will be prepared using a Medical's Cellenis® PRP System (Eclipse). A target volume of 6-10 mL of PRP will be collected per patient. Whole blood will undergo a two-step centrifugation protocol: an initial spin at 1,600 RPM for 10 minutes, followed by a second spin at 3,000 RPM for 10 minutes, with plasma separation completing after approximately 20 minutes total processing time.
Two of the three arms will additionally receive photobiomodulation (PBM), the application of specific wavelengths of light to biological tissue to modulate cellular activity, delivered as a 10-minute treatment cycle with a Metacell Technologies System. Red light (approximately 630-660 nm) has been studied for its capacity to enhance cellular metabolic activity and support tissue repair, while blue light (approximately 400-470 nm) has documented antimicrobial and anti-inflammatory properties relevant to scalp health.
Red-light protocol: Stimulus 1: 620 nm, 1 J/cm², 10 minutes; Stimulus 2: 4°C cooling, 15 minutes.
Blue-light protocol (exosome-based): Stimulus 1: 467 nm, 1 J/cm², 10 minutes; Stimulus 2: 37°C, 10 minutes.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •Diagnosed Androgenetic Alopecia
- •Willing to comply with protocol and follow up
排除标准
- •Active scalp infection or disease
- •Prior PRP within last 6 months
- •Use of hair growth medication topical or oral
- •Platelet dysfunction or anticoagulation
- •Pregnant or breastfeeding
- •history of keloid infection
结局指标
主要结局
Hair rate Terminal/Vellus (%)
时间窗: Trichoscopy taken at baseline, 1 month, 2 months, 6 months, 9 months, 12 months
Taken from TrichoLab Trichoscopy
Hair Density (N/cm^2)
时间窗: Trichoscopy taken at baseline, 1 month, 2 months, 6 months, 9 months, 12 months
Taken from TrichoLab Trichoscopy
次要结局
- Hair Density Terminal and Vellus (N/cm^2)(Trichoscopy taken at baseline, 1 month, 2 months, 6 months, 9 months, 12 months)
- Mean Thickness (um)(Trichoscopy taken at baseline, 1 month, 2 months, 6 months, 9 months, 12 months)
- Cumulative Hair Thickness (mm/cm^2)(Trichoscopy taken at baseline, 1 month, 2 months, 6 months, 9 months, 12 months)
研究者
Kimberly Meathrel
Surgeon and Principal Investigator
BespokeSkin MD