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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Dr. Matt Leavitt, DO
- Número de telefone: 321-594-6851
- E-mail: matt@xtresse.com
Locais de estudo
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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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Contato:
- Dr. Priya Pohani
- E-mail: DrPPohani@adcsclinics.com
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Port Orange, Florida, Estados Unidos, 32127
- Advanced Dermatology & Cosmetic Surgery
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Contato:
- Kiya Arbogast
- Número de telefone: 386-322-8310
- E-mail: DrCDunn@adcsclinics.com
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Investigador principal:
- Charles Dunn, MD
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
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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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Comparador de Placebo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of Adverse Events associated with Treatment
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Participant self-assessment of hair improvements collected via questionnaire
Prazo: 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
- Diretor de estudo: Melissa Y Rayner, MS, Restore Biologics Holdings, Inc. dba Xtressé
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- XTSM-2026-001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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