A Prospective, Randomized, Triple-blind Comparative Study of Exosome and Exosomes-containing Formulation Versus Placebo in Treating Alopecia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Trichoscopic parameters: Total Hair Density
研究概览
简要总结
This study investigates a novel exosome-based plant formulation for treating male pattern baldness (androgenetic alopecia), a condition that affects self-esteem and well-being. Current treatments like minoxidil and finasteride offer limited effectiveness and may cause side effects, increasing demand for safer, more effective alternatives. Exosomes, small extracellular vesicles that facilitate cell repair and communication, show promise in promoting hair regeneration. Botanical extracts, such as Ecklonia cava (brown seaweed) and Thuja orientalis (medicinal plant), have also demonstrated hair growth benefits. This study combines these components into a single formulation to enhance therapeutic outcomes.
A randomized, double-blind, placebo-controlled trial is conducted to evaluate the efficacy of this exosome-containing formulation. The study enrolls 20 male participants aged 18 to 35 with Norwood 2-3 androgenetic alopecia. Participants are randomly assigned to receive either the exosome treatment (containing 10 billion exosomes with Ecklonia cava and Thuja orientalis extracts) or a placebo (0.9% sodium chloride). The treatment is administered through four biweekly sessions of intradermal scalp injections, performed by a certified aesthetic physician under strict aseptic conditions.
Hair growth is assessed using standardized photography, trichoscopic imaging, and hair density measurements, with a blinded medical assessor ensuring objective evaluation. Additionally, participants complete self-reported satisfaction surveys to gauge perceived effectiveness. Strict ethical guidelines are followed, including informed consent and exclusion of individuals with underlying medical conditions, recent hair treatments, or lifestyle factors that could influence results. The study aims to provide scientific evidence on the safety and efficacy of this exosome-based therapy as a potential alternative for hair restoration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Norwood grade 2-3 androgenic alopecia among male Malaysians.
- •Aged between 20 and 50 years.
- •Demonstrated the ability to comprehend the study protocol and information provided by the investigators.
- •Participants willing to give informed consent.
排除标准
- •Pre-existing thyroid disorders, bleeding disorders, or diabetes.
- •Current use of any medical hair treatment.
- •Corticosteroid or immunosuppressive drug use.
- •Alopecia classified as Norwood scale 1, 4, 5, 6, 7, or cicatricial alopecia.
结局指标
主要结局
Trichoscopic parameters: Total Hair Density
时间窗: Baseline, 12, and 16 weeks post-treatment
High-resolution trichoscopic images were captured using the Dino-Lite Trichoscope (Dino-Lite Europe, Almere, The Netherlands) at a standardized anatomical reference point, defined as the intersection of a vertical line descending from the lateral canthus of one eye (left or right) and a horizontal coronal line connecting both ears. Images were taken over two circular scalp areas, each with a diameter of 0.5 cm. These images were analyzed using Trichoscale Pro® software, which enables precise automated quantification of scalp structures. All measurements were subsequently verified manually by a blinded medical assessor to ensure accuracy. Total hair density was assessed as a primary parameter, with results expressed in hairs per square centimeter (hairs/cm²). The assessments were performed at baseline, 12, and 16 weeks post-treatment.
Modified global photographic assessment score (MGPA)
时间窗: Baseline, 12 weeks, and 16 weeks post-treatment.
Canon EOS 200D II digital camera (Canon, Taichung, Taiwan, China) was used for standardized profile photography, capturing lateral, facial, occipital, and cephalic views. The modified global photographic assessment score (MGPA) was used with the standardized 7-point rating score using scalp photographs: 1, significant disease progression; 2, moderate disease progression; 3, slight disease progression; 4, no change; 5, slight improvement; 6, moderate improvement; and 7, significant improvement. The scalp photographs of the subjects was evaluation of MGPA by blinded medical assessor. The assessments were performed at baseline, 12, and 16 weeks post-treatment.
次要结局
- Trichoscopic parameters: Number of Empty Follicles(The assessments were performed at baseline, 12, and 16 weeks post-treatment.)
- Trichoscopic Parameter: Percentage of Follicles with Peripilar Sign(The assessments were performed at baseline, 12, and 16 weeks post-treatment.)
- Trichoscopic Parameter: Presence of Fibrosis(Assessments were carried out at baseline, 12 weeks, and 16 weeks post-treatment.)
- Hair Growth Satisfaction Scale (HGSS)(Baseline, and week 16)
- Trichoscopic Parameter: Presence of Honeycomb Pigment Pattern (HCPP)(Assessments were conducted at baseline, 12 weeks, and 16 weeks post-treatment.)