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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Dr. Matt Leavitt, DO
- Numero di telefono: 321-594-6851
- Email: matt@xtresse.com
Luoghi di studio
-
-
Florida
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Maitland, Florida, Stati Uniti, 32751
- Advanced Dermatology & Cosmetic Surgery
-
Investigatore principale:
- Matt Leavitt, DO
-
Contatto:
- Dr. Priya Pohani
- Email: DrPPohani@adcsclinics.com
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Port Orange, Florida, Stati Uniti, 32127
- Advanced Dermatology & Cosmetic Surgery
-
Contatto:
- Kiya Arbogast
- Numero di telefono: 386-322-8310
- Email: DrCDunn@adcsclinics.com
-
Investigatore principale:
- Charles Dunn, MD
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Xtressé Nutraceutical Supplement Active
Xtressé Nutraceutical Supplement Participants will receive a 90 day supply of gummy supplement 2 times during the study.
Participants will take supplement daily and notate usage in log.
|
L'integratore nutraceutico è potenziato dalla miscela bioattiva X-3 brevettata e contiene estratti vegetali e composti rigenerativi non comuni negli integratori per capelli esistenti.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of Adverse Events associated with Treatment
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Participant self-assessment of hair improvements collected via questionnaire
Lasso di tempo: 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.
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From enrollment to the end of study at 6 months
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Melissa Y Rayner, MS, Restore Biologics Holdings, Inc. dba Xtressé
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- XTSM-2026-001
Piano per i dati dei singoli partecipanti (IPD)
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