Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia
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 how safe and effective it is to improve hair growth using an active gummy treatment in men with androgenic alopecia.
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 visits after voluntary consent has been given. Participants will be given a 90-day supply of the gummies at visits 1 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.
연구 개요
상세 설명
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 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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Dr. Matt Leavitt, DO
- 전화번호: 321-594-6851
- 이메일: matt@xtresse.com
연구 장소
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Florida
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Maitland, Florida, 미국, 32751
- Advanced Dermatology & Cosmetic Surgery
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수석 연구원:
- Matt Leavitt, DO
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연락하다:
- Dr. Priya Pohani
- 이메일: DrPPohani@adcsclinics.com
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Port Orange, Florida, 미국, 32127
- Advanced Dermatology & Cosmetic Surgery
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연락하다:
- Kiya Arbogast
- 전화번호: 386-322-8310
- 이메일: DrCDunn@adcsclinics.com
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수석 연구원:
- Charles Dunn, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Xtressé Nutraceutical Supplement Active
Xtressé Nutraceutical Supplement Participants 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 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis
기간: 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 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Adverse Events associated with Treatment
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Participant self-assessment of hair improvements collected via questionnaire
기간: 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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공동 작업자 및 조사자
수사관
- 연구 책임자: Melissa Y Rayner, MS, Restore Biologics Holdings, Inc. dba Xtressé
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- XTSM-2026-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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