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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dr. Matt Leavitt, DO
- Número de teléfono: 321-594-6851
- Correo electrónico: matt@xtresse.com
Ubicaciones de estudio
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Florida
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Maitland, Florida, Estados Unidos, 32751
- Advanced Dermatology & Cosmetic Surgery
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Investigador principal:
- Matt Leavitt, DO
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Contacto:
- Dr. Priya Pohani
- Correo electrónico: DrPPohani@adcsclinics.com
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Port Orange, Florida, Estados Unidos, 32127
- Advanced Dermatology & Cosmetic Surgery
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Contacto:
- Kiya Arbogast
- Número de teléfono: 386-322-8310
- Correo electrónico: DrCDunn@adcsclinics.com
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Investigador principal:
- Charles Dunn, MD
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Comparador de placebos: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis
Periodo de tiempo: 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
Periodo de tiempo: 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.
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From enrollment to the end of treatment at 6 months
|
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Hair Density Changes measured by SOCAi
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Adverse Events associated with Treatment
Periodo de tiempo: 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
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Participant self-assessment of hair improvements collected via questionnaire
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Melissa Y Rayner, MS, Restore Biologics Holdings, Inc. dba Xtressé
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- XTSM-2026-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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