Pilot Study to Evaluate the Efficacy and Safety of Xvie (Human Amniotic Fluid Derived Nanoparticle Solution) Delivered Into the Scalp by Microneedling in Women With Self-perceived Thinning Hair
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Within-subject increase in hair quality, volume, and thickness, assessed via Canfield HairMetrix® Phototrichogram Analysis
研究概览
简要总结
The goal of this study is to determine how safe and effective it is to improve hair growth using XVIE solution applied on the scalp of women with self-perceived thinning hair.
The main aims of this trial are:
- To confirm using photographic analysis, changes in the quality, volume, and thickness of hair.
- To gauge patient satisfaction with hair changes and application process.
Participants who qualify will complete 5 to 6 visits after voluntary consent has been given. Participant's scalp will be numbed and the XVIE solution will be applied by microneedling. Photographs will be taken at each visit to measure changes in hair volume, thickness, and growth. Every participant will receive active treatment twice over the 4 month period.
详细描述
XVIE is a proprietary, additive-free Human amniotic fluid (hAF) based therapy, containing a diverse array of bioactive molecules including growth factors, cytokines, hyaluronic acid, extracellular matrix proteins, and extracellular vesicles including exosomes. Extensive research have shown the ability of Xvie components to support cellular proliferation, angiogenesis, immune regulation, and matrix remodeling which has the potential to reverse underlying cause of hair loss.
In the study, participants will be asked to complete the following:
- Provide basic personal Information
- Provide a Medical & Surgical History
- Follow study requirements to avoid certain medication and treatments
- Complete all study visits and follow-up calls
- Complete self-assessments and treatment use logs
- Allow clinical assessment and photographic documentation of treatment.
All participants have the right to refuse further participation in the study at any time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 28 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 28-65 years with self-perceived thinning hair (confirmed by an investigator).
- •Ludwig Scale 1 to 2
- •Fitzpatrick skin types I to VI.
- •Ability and willingness to comply with the study protocol.
- •Commitment to using effective contraception throughout the study if of childbearing potential.
排除标准
- •Pregnancy, nursing, or recent initiation of hormone therapy.
- •Change in other hair treatments within 3 months prior to the study.
- •Known uncontrolled health conditions (e.g., poorly controlled diabetes, hypertension).
- •History of hair or scalp disorders that could interfere with study results.
- •History of keloid formation or poor wound healing
- •History of bleeding and/or clotting disorders
研究组 & 干预措施
XVIE microneedling process applied to the scalp twice over a 4 month period.
XVIE is proprietary, additive-free human amniotic fluid derived product that contains an diverse array of bioreactive molecules including growth factors, cytokines, ECM proteins, exosomes, and hyaluronic acid.
干预措施: XVIE (Other)
结局指标
主要结局
Within-subject increase in hair quality, volume, and thickness, assessed via Canfield HairMetrix® Phototrichogram Analysis
时间窗: From enrollment to the end of treatment at 4 months
Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months after multiple treatments with XVIE
Incidence of Adverse Events associated with Treatment
时间窗: From first treatment until the end of treatment at 4 months.
Collect and quantify the incidence of treatment-related adverse events and treatment-related serious adverse events that occur during the trial within 30 days of microneedling treatment.
次要结局
- Hair Density Changes measured by SOCAi(From enrollment to the end of the study at 4 months)