A Prospective, 8-Month, Randomized Pilot Study of TargetCool™ Cryo-Modulation and BENEV Exosome Regenerative Complex+® for Hair Density Enhancement in Adults With Non-Scarring Hair Thinning
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in average hair width
研究概览
简要总结
This clinical trial is testing a new approach to help improve hair thinning using a combination of cosmetic treatments. The purpose of the study is to learn whether applying exosomes to the scalp, along with microneedling and a precision cooling device called TargetCool™. This study aims to determine whether this combination approach offers synergistic benefits for individuals with hair thinning.
Exosomes are tiny particles that come from stem cells and contain growth factors and other nutrients. They are being studied for their potential to help regenerate skin and hair. TargetCool™ is an FDA-cleared device that uses precision cooling to reduce inflammation and improve comfort. Microneedling is a common, minimally invasive procedure that uses small needles to stimulate the skin and help absorb topical products more effectively.
The study will include healthy men (ages 18 to 70) and women (ages approximately 45 to 70) who are not of childbearing potential. A total of 9 to 15 participants will be randomly placed into one of three groups:
Group 1: Exosomes with TargetCool™ Group 2: Microneedling followed by exosomes and TargetCool™ Group 3: Microneedling followed by exosomes only Participants will receive four treatments over 9 weeks. Each visit may include microneedling, TargetCool™ treatment, and exosome application depending on group assignment. A small tattoo will be placed on the scalp to help capture consistent photographs, and a special imaging system (Canfield HairMetrix®) will be used to measure hair changes.
Participants will return for follow-up visits at 3 and 6 months after the final treatment. The results will help determine whether this combination of cosmetic treatments is safe and beneficial for people experiencing hair thinning.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy males between 18-70 years of age and females not of child-bearing age 45-70 years of age of all Fitzpatrick Skin Types.
- •Subjects must be willing to provide verbal understanding and sign an Informed Consent Form, HIPAA Form and Photography Release Form approved by the Institutional Review Board.
- •Subjects must be in general good health, as determined by the Investigator.
- •Subjects with hair thinning as determined on initial study assessment by the Investigator.
- •Patients are not on medical treatment or have been on stable treatment for >12 months (eg. minoxidil, finasteride, dutasteride, PRP, LLLT)
- •Subjects willing to not substantially change their current diet, medications, or exercise routines for the duration of the study. If a subject receives physician guidance during the study to change diet, medications, or exercise routine, the subject will need to notify the clinic as soon as possible.
- •Subjects willing to have Canfield digital photography of the entire head/hair region for overall evaluation of general hair growth and quality by the Investigator.
- •Subjects willing to have TargetCool boosting or microneedling of the scalp region with or followers by application of exosomes.
- •Subjects must be willing and able to complete and understand the rating questionnaires.
- •Subjects must be willing and able to attend all study visits and comply with the post procedure and lifestyle instructions
排除标准
- •Subjects who are of child-bearing age, pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study.
- •Subjects who have had a hair transplant.
- •Subjects who have recently (within the last 3 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (3 months or longer) in order to be eligible for the study.
- •Subjects who started any new hair loss treatment in the last 12 months.
- •Subjects who have used prescription drugs known to affect the hair growth cycle within the last 3 months (e.g., hormone-based birth control for less than 12 months, cyproterone acetate, aldactone/spironolactone or any 5-alpha-reductase inhibitor).
- •Subjects who have regularly used anti-androgenic therapies (i.e. spironolactone, flutamide, cyproterone acetate, progesterone and/or bicalutamide) or undergone any other hair or scalp treatments within the last 12 months.
- •Subjects suffering from other hair loss disorders, such as alopecia areata, scarring alopecia, and telogen effluvium as determined during initial study assessment and physical exam by the Investigator.
- •Subjects with self-reported uncontrolled diseases (i.e. diabetes, hypertension, hyperthyroidism, hypothyroidism, etc.). Whether medical conditions are under control with or without treatment will be assessed on an individual basis by the Investigator based on her medical and clinical expertise.
研究组 & 干预措施
Microneedling followed by TargetCool Boosting with Benev exosome
干预措施: Scalp tattoo (Device)
TargetCool with Benev exosome Boost
干预措施: Scalp tattoo (Device)
TargetCool with Benev exosome Boost
干预措施: Canfield HairMetrix® (Device)
TargetCool with Benev exosome Boost
干预措施: TargetCool (Device)
Microneedling followed by TargetCool Boosting with Benev exosome
干预措施: Canfield HairMetrix® (Device)
Microneedling followed by TargetCool Boosting with Benev exosome
干预措施: TargetCool (Device)
Microneedling followed by TargetCool Boosting with Benev exosome
干预措施: Microneedle-facilitated lidocaine application (Device)
Microneedling to depth of 0.5mm followed by Benev exosome topical
干预措施: Scalp tattoo (Device)
Microneedling to depth of 0.5mm followed by Benev exosome topical
干预措施: Canfield HairMetrix® (Device)
Microneedling to depth of 0.5mm followed by Benev exosome topical
干预措施: Microneedle-facilitated lidocaine application (Device)
结局指标
主要结局
Change in average hair width
时间窗: 32 weeks (8 months)
This is the average hair width calculated in micrometers by the Canfield HairMetrix System.
Change in Terminal Hair Counts
时间窗: 32 weeks (8 months)
Terminal hair is defined as coarse hair, short or long, found on the scalp with minimum cross-sectional diameter of 40 micrometers. This is calculated by the Canfield HairMetrix System.
Change in Vellus Hair Counts
时间窗: 32 weeks (8 months)
Vellus hair is defined as fine, short hairs found on the scalp with maximum cross-sectional diameter of 40 micrometers. This is calculated by the Canfield HairMetrix System.
Change in Total Hair Counts
时间窗: 32 weeks (8 months)
Total hairs equals the sum of Terminal and Vellus hairs in the target area. This is calculated by the Canfield HairMetrix System.
次要结局
- Change in Investigator Hair Growth Global Improvement Scale(32 weeks (8 months))
- Change in Subject Hair Self-Assessment Questionnaire scores(32 weeks (8 months))
- Change in Hair Treatment Subject Satisfaction Questionnaire scores(32 weeks (8 months))