Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia
A Multi-center, Randomized, Double-Blind, Placebo- Controlled Pilot Study to Evaluate the Efficacy and Safety of Xtressé™ Gummy-Based Nutraceutical Supplement in Men With Androgenic Alopecia
The goal of this study is to determine if Xtresse' gummy is safe and may help regrow hair in men with androgenic alopecia (common pattern hair loss). Forty-eight participants will be randomly assigned to receive either Xtresse' active gummy or placebo. Neither staff not participant will know which treatment is given.
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 3 in-person visits. Participants will be given a 90-day supply of the gummies at visits 1 (after voluntary consent is given) and 2 to cover the 6-month study period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth.
研究概览
详细说明
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) 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 active or placebo 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 male adult between 18 to 65 years of age Have hair loss in vertex region. 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 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.
All participants have the right to refuse further participation in the study at any time.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Dr. Matt Leavitt, DO
- 电话号码：321-594-6851
- 邮箱：matt@xtresse.com
学习地点
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Florida
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Maitland、Florida、美国、32751
- Advanced Dermatology & Cosmetic Surgery
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首席研究员：
- Matt Leavitt, DO
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接触：
- Dr. Priya Pohani
- 邮箱：DrPPohani@adcsclinics.com
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Port Orange、Florida、美国、32127
- Advanced Dermatology & Cosmetic Surgery
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接触：
- Kiya Arbogast
- 电话号码：386-322-8310
- 邮箱：DrCDunn@adcsclinics.com
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首席研究员：
- Charles Dunn, MD
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Males aged 18-65
- Norwood III to IV, vertex focused
- Fitzpatrick skin type I to VI
- Ability and willingness to comply with study protocol
Exclusion Criteria:
- Change in other hair treatments in 3 months prior to study enrollment.
- Known uncontrolled health conditions.
- History of hair or scalp disorders that could interfere with study results.
- History of metabolic syndrome.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Xtressé Nutraceutical Supplement Active
Xtressé Nutraceutical Supplement 32 participants will be randomized to this group and receive a 90 day supply of the gummy supplement 2 times during the study.
Participants will take supplement daily and notate usage in log.
|
The nutraceutical supplement is powered by proprietary X-3 BioActive Blend and contains plant based extracts and regenerative compounds not commonly found in existing hair supplements.
The dosage is 2 gummies taken once per day.
|
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安慰剂比较：Placebo
16 individuals will be randomized to this group and will receive a 90 day supply of the gummy supplement 2 times during the study.
Participants will take supplement daily and notate usage in log.
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The placebo supplement will contain no active ingredients.
Participants will receive 3 month supply 2 times during the study.
Participants will take 2 supplements daily.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis
大体时间：From enrollment to the end of treatment at 6 months
|
Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 6 months of taking Xtressé™ Supplements.
Measurements of density as measured hair per cm².
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From enrollment to the end of treatment at 6 months
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Within-subject increase in hair thickness assessed via Canfield HairMetrix® Phototrichogram Analysis
大体时间：From enrollment to the end of treatment at 6 months
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Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 6 months of taking Xtressé™ Supplements.
Measurements of follicular unit vellus/terminal ratio.
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From enrollment to the end of treatment at 6 months
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Hair Density Changes measured by SOCAi
大体时间：From enrollment to the end of treatment at 6 months
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Images will be captured using the the SOCAi system at baseline and Days 90, and 180, to evaluate hair density changes.
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From enrollment to the end of treatment at 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of Adverse Events associated with Treatment
大体时间：From first treatment until the end of treatment at 6 months
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Collect and quantify the incidence of treatment-related adverse events and treatment-related serious adverse events associated with the daily intake of supplement
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From first treatment until the end of treatment at 6 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Participant self-assessment of hair improvements collected via questionnaire
大体时间：From enrollment to the end of study at 6 months
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Observations and changes in hair loss graded on scale of 0 to 4 with 0 as no change and 4 as a very severe outcome.
Observations are based on self-assessments completed at baseline and Day 180.
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From enrollment to the end of study at 6 months
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合作者和调查者
调查人员
- 研究主任：Melissa Y Rayner, MS、Restore Biologics Holdings, Inc. dba Xtressé
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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