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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Dr. Matt Leavitt, DO
- 電話番号：321-594-6851
- メール：matt@xtresse.com
研究場所
-
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Florida
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Maitland、Florida、アメリカ、32751
- Advanced Dermatology & Cosmetic Surgery
-
主任研究者：
- Matt Leavitt, DO
-
コンタクト：
- Dr. Priya Pohani
- メール：DrPPohani@adcsclinics.com
-
Port Orange、Florida、アメリカ、32127
- Advanced Dermatology & Cosmetic Surgery
-
コンタクト：
- Kiya Arbogast
- 電話番号：386-322-8310
- メール：DrCDunn@adcsclinics.com
-
主任研究者：
- Charles Dunn, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
プラセボコンパレーター：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis
時間枠：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.
|
From enrollment to the end of treatment at 6 months
|
|
Within-subject increase in hair thickness assessed via Canfield HairMetrix® Phototrichogram Analysis
時間枠：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 follicular unit vellus/terminal ratio.
|
From enrollment to the end of treatment at 6 months
|
|
Hair Density Changes measured by SOCAi
時間枠：From enrollment to the end of treatment at 6 months
|
Images will be captured using the the SOCAi system at baseline and Days 90, and 180, to evaluate hair density changes.
|
From enrollment to the end of treatment at 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Adverse Events associated with Treatment
時間枠：From first treatment until the end of treatment at 6 months
|
Collect and quantify the incidence of treatment-related adverse events and treatment-related serious adverse events associated with the daily intake of supplement
|
From first treatment until the end of treatment at 6 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Participant self-assessment of hair improvements collected via questionnaire
時間枠：From enrollment to the end of study at 6 months
|
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.
|
From enrollment to the end of study at 6 months
|
協力者と研究者
捜査官
- スタディディレクター：Melissa Y Rayner, MS、Restore Biologics Holdings, Inc. dba Xtressé
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- XTSM-2026-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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