Pilot Study to Evaluate the Efficacy and Safety of Xtressé™ Gummy-Based Nutraceutical Supplement 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
- 60
- 试验地点
- 8
- 主要终点
- Hair Density Changes measured by SOCAi
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 an active gummy treatment in 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.
- Monitor and report any adverse events associated with the daily intake of Xtressé
Participants who qualify will complete 5 visits after voluntary consent has been given. Participants will be given a 30-day supply of the gummies at each visit over a 4-month period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth.
详细描述
In the study, participants will be asked to complete the following:
- Provide basic personal information (including date of birth, gender, race and ethnicity)
- Provide their medical/ surgical history and perform a medical exam (including but not limited to symptom-directed physical exam, skin type, vital signs, height, weight, and pregnancy test)
- Follow study rules such as avoiding certain medications and treatments
- Provide information on any medications, treatments or reactions that started after the study began
- Take gummy treatment daily and complete a treatment diary
- Allow clinical assessments and documentation of the treatment, such as photography, hair density measurements, any reactions or side effects
To qualify for this trial, participants must:
- Be a female adult between 28 to 65 years of age
- Have consistent self-perceived thinning hair.
- Give voluntary written consent
- Be willing to follow study instructions and complete study requirements, including maintaining current diet and hair care routine, not using non-approved lotions and creams on the treatments areas
- Allow photographs of the front and top area of the scalp
- Not be pregnant or breast feeding before and during the study and agree to use acceptable forms of birth control
- Confirm they are not sensitive to any of the study treatment ingredients
All photographs of the treatment area collected during the study will be used as study data.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-65 years with self-perceived thinning hair (confirmed by an investigator).
- •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 metabolic syndrome.
研究组 & 干预措施
Xtressé Nutraceutical Supplement Active
Other: Xtressé Nutraceutical Supplement Participants will receive a 30 day supply of gummy supplement 4 times during the study. Participants will take supplement daily and notate usage in log.
干预措施: Xtressé Hair Growth Gummies (Other)
结局指标
主要结局
Hair Density Changes measured by SOCAi
时间窗: From enrollment to the end of the study at 4 months
Images will be captured using the the SOCAi system at baseline and Days 30, 60, 90, and 120, to evaluate hair density changes.
Within-subject increase in hair density 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 taking Xtressé™ Supplements. Measurements of density as measured hair per cm².
Within-subject increase in hair 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 taking Xtressé™ Supplements. Measurements of follicular unit vellus/terminal ratio.
次要结局
- Incidence of Adverse Events associated with Treatment(From first treatment until the end of treatment at 4 months)