A Randomized, Double-blind, Single-center, Self-controlled Exploratory Clinical Study of Exosomes for Hairloss Treatment
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Comparison of localized hair density
研究概览
简要总结
Many people suffer from alopecia, which is caused by hereditary factors, emotional stress, and psychiatric disorders. There are devastating physical and psychological consequences as a result. Exosomes are isolated from donated human mesenchymal stem cells and purified using specific processing. This study is a randomized, double-blind, dose-escalation clinical trial designed to evaluate the efficacy and safety of exosomes therapy for alopecia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are able to read documents and can sign informed consent.
- •18~75 years old (including the threshold), gender is not limited.
- •The subject's "hair loss grade" meets the following criteria:
- •1) BASP grade: Basic type (M2 to M3, or C2 to C3, or U1 to U3) or special type (V1 to V3, or F1 to F3); 2) For female: Ludwig Grade I to II. Or for male: Hamilton-Norwood Grade III to IV; 3) Hair density by phototrichogram: ≤ 190 hair/cm² ;
- •Hair dryness ≥ 5%;
- •Until withdrawal/completion of the study, subjects agree not to undergo any topical treatment for hair loss and agree to use a neutral shampoo.
排除标准
- •People with patchy or diffuse baldness, syphilitic alopecia, scarring alopecia, malnutrition, chemotherapy/radiotherapy-induced hair loss.
- •Those with a combination of diseases that have an impact on hair growth.
- •Use of medications, medicated shampoos, or hair care products that may interfere with efficacy evaluation within 3 months prior to screening (oral administration of therapeutic agents for androgenetic alopecia must be discontinued for at least 6 months).
- •Have received scalp radiation and/or laser or surgical therapy within 3 months prior to screening.
- •Participated or are participating in a interventional clinical trial within 3 months.
- •Persons with a history of hereditary alopecia areata.
- •Women who are pregnant or breastfeeding, or male/female subjects whose own/partner's pregnancy is planned within 6 months.
- •Have undergone hair transplantation in the previous 24 months.
- •Individuals testing positive for active infectious diseases or carriers of communicable pathogens.
- •Those with keloid, keloid-prone or hyperplastic scarring.
- •Those who, in the opinion of the investigator, are otherwise unfit to participate in this clinical study.
研究组 & 干预措施
exosomes
Subjects will receive 5E8 ~5E9 particles/cm² of exosome therapy in the study area during the dose escalation phase.
干预措施: exosomes (Biological)
saline
The control site will receive the same volume of saline as the exosomes administered in the study site.
干预措施: saline (Other)
结局指标
主要结局
Comparison of localized hair density
时间窗: 3rd month after 3 treatments
Quantify hair counts within designated 1.5 cm × 1.5 cm fixed areas in both the study area and control area, and compare the localized hair density (hair/cm²) between the two areas.
Safety Assessment
时间窗: From the initial treatment administration to the subject withdrawal from the study.
Incidence of treatment emergent adverse events (TEAEs)
Comparison of overall hair density
时间窗: 3rd month after 3 treatments
Evaluate and score overall hair density in both the study area and control area using an 8-level assessment scale, followed by a comparative analysis of the two areas.
次要结局
- Change of hair density(3rd and 6st month after 3 treatments)