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临床试验/NCT07751523
NCT07751523已完成不适用

Effect of Preoperative Fractional CO₂ Laser on the Outcome of Follicular Unit Extraction Hair Transplantation Combined With Intraoperative Platelet-Rich Plasma in Patients With Secondary Cicatricial Alopecia

Tanta University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Clinical improvement after hair transplantation

研究概览

简要总结

Secondary cicatricial alopecia is characterized by permanent hair loss due to destruction of hair follicles following trauma, burns, infection, or other causes. Hair transplantation using follicular unit extraction (FUE) is an established treatment; however, graft survival may be limited by poor vascularity and fibrosis within scar tissue. Fractional carbon dioxide (CO₂) laser has been proposed to improve the recipient site by enhancing tissue remodeling and vascularization before transplantation.

This prospective comparative clinical study evaluated the effect of three preoperative sessions of fractional CO₂ laser followed by FUE hair transplantation with intraoperative platelet-rich plasma (PRP) injection compared with FUE hair transplantation combined with intraoperative PRP alone in patients with stable secondary cicatricial alopecia. Twenty participants were allocated into two groups of 10 patients each and were followed for 9 months after hair transplantation.

The primary objective was to determine whether preoperative fractional CO₂ laser improves the clinical outcome of FUE hair transplantation in secondary cicatricial alopecia. Outcomes included clinical improvement, dermoscopic assessment of hair growth, patient satisfaction, and scar assessment.

详细描述

Secondary cicatricial alopecia is characterized by permanent destruction of hair follicles resulting from trauma, burns, infection, radiation, or other non-follicular pathological processes. Hair transplantation using follicular unit extraction (FUE) is an established surgical treatment for stable secondary cicatricial alopecia; however, graft survival and cosmetic outcomes may be compromised by fibrosis, reduced vascularity, and poor tissue elasticity within scarred recipient sites. Fractional carbon dioxide (CO₂) laser has been suggested to improve scar quality by promoting tissue remodeling, neovascularization, and wound healing, potentially enhancing the recipient bed before hair transplantation. Platelet-rich plasma (PRP), which contains a high concentration of growth factors, may further improve graft survival and hair growth by stimulating tissue regeneration.

This prospective comparative clinical study was conducted to evaluate whether preoperative fractional CO₂ laser treatment improves the outcome of FUE hair transplantation combined with intraoperative PRP injection in patients with stable secondary cicatricial alopecia. Twenty participants of both sexes with stable secondary cicatricial alopecia and realistic treatment expectations were enrolled. Patients with chronic systemic diseases, pregnancy or lactation, platelet or blood disorders, history of keloid formation, scar duration less than one year, or inadequate donor sites were excluded. The study was approved by the Research Ethics Committee of Tanta University Hospitals (Approval No. 34430/1/21), and written informed consent was obtained from all participants before enrollment.

Participants were assigned into two treatment groups. Group A received three sessions of fractional CO₂ laser treatment at one-month intervals before surgery, followed one month later by FUE hair transplantation combined with intraoperative PRP injection. Group B underwent direct FUE hair transplantation combined with intraoperative PRP injection without preoperative laser treatment. PRP was prepared from autologous venous blood using a double-centrifugation technique and injected into the recipient scar tissue during the transplantation procedure. Hair grafts were harvested using the FUE technique from the donor area and transplanted into the scarred recipient site according to standard surgical protocols.

Participants were followed for nine months after hair transplantation. Clinical assessment included standardized photographic evaluation by three blinded dermatologists and two plastic surgeons. Dermoscopic examination was performed before and after treatment to evaluate follicular regeneration and the percentage of scar surface covered by growing hair. Patient satisfaction and scar severity were also assessed using validated scar assessment scales. The primary objective was to determine whether preoperative fractional CO₂ laser enhances the clinical outcome of FUE hair transplantation with intraoperative PRP in patients with secondary cicatricial alopecia. Secondary objectives included evaluation of dermoscopic hair regrowth, patient satisfaction, and changes in scar assessment scores

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
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with stable secondary cicatricial alopecia. Male or female participants. Participants with realistic expectations regarding treatment outcomes. All hair types (silky, curly, or normal hair). Presence of an adequate donor site for follicular unit extraction (FUE). Ability and willingness to provide written informed consent.

排除标准

  • Extremes of age. Chronic systemic diseases, including hepatic or renal disease. Receiving chemotherapy or systemic corticosteroid therapy. Platelet disorders or other blood disorders. Pregnancy or lactation. History of keloid formation. Scar duration less than 1 year. Absence of a suitable donor site for hair transplantation

研究组 & 干预措施

fractional plus hair transplantation and PRP

Active Comparator

Treatment injection

干预措施: hair transplantation preceded by fractional and PRP (Procedure)

Hair transplantation plus PRP

Placebo Comparator

PLACEBO

干预措施: hair transplantation preceded by fractional and PRP (Procedure)

结局指标

主要结局

Clinical improvement after hair transplantation

时间窗: 9 months after follicular unit extraction (FUE) hair transplantation

Excellent (\>75% improvement) Good (50-75%) Fair (25-49%) Poor (\<25%)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Hamdy Soliman

Lecturer at Dermatology and Venerology, Faculty of Medicine

Tanta University

研究点 (1)

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