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A Double-Blind, Randomized, Double-Dummy, Active and Placebo-Controlled Clinical Study to Assess the Effect of an Oral Skin Supplement on Skin Health in Healthy Adults

28 de julio de 2026 actualizado por: Amazentis SA
The aim of this study is to investigate the impact of a two skin from within nutritional supplement(s) compared to placebo on skin aging biomarker changes.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

90

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Anurag Singh, MD PhD
  • Número de teléfono: +41215221274
  • Correo electrónico: asingh@timeline.com

Copia de seguridad de contactos de estudio

  • Nombre: Brad Currier, PhD
  • Número de teléfono: +41215221274
  • Correo electrónico: bcurrier@timeline.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  1. Male and female trial participants in the age group of 35 -65 years, both ages inclusive.
  2. Trial participants in good general health, as determined by the Investigator based on medical history, physical examination, vital signs, and clinical laboratory evaluations (CBC, LFT, and RFT).
  3. Trial participants presenting with visible signs of facial skin aging, as assessed by the Investigator.
  4. Trial participants willing to consume the assigned study products daily for 8 weeks in accordance with the study protocol.
  5. Trial participants must be willing to undergo two minimally invasive skin biopsies collected from the upper arms.
  6. Trial participants must be willing to provide blood samples for plasma collection and laboratory Investigations.
  7. Trial participants willing to refrain from initiating any new skin care products, oral supplements, or anti-aging treatments during the study.
  8. Trial participants willing to maintain their permitted and restricted skincare, diet, and lifestyle habits throughout the study.
  9. Trial participants free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face and upper arms as determined by the dermatologist.
  10. Trial participants who agree not to have direct and excessive sun exposure (not more than half an hour daily and during that time use of umbrella to cover face and upper arms).
  11. Trial participants willing to refrain from bleaching or any other procedures including facial etc. on face during the study period.
  12. Trial participants willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
  13. Trial participants willing to abide by and comply with study protocol.

Exclusion Criteria:

  1. Trial participants with known allergy, hypersensitivity, or intolerance to the study products or any of their ingredients, which, in the opinion of the Investigator, may impact participant safety, skin condition, or study outcomes.
  2. Trial participants with clinical non-significant laboratory values or clinically significant findings in CBC, LFT, or RFT that, in the opinion of the Investigator, may affect participant safety or study participation.
  3. Trial participants with a history or presence of clinically significant systemic diseases, including cardiovascular, immunological, vascular, hepatic, gallbladder, renal, or other uncontrolled medical disorders that, in the opinion of the Investigator, may interfere with study participation or study assessments.
  4. Trial participants with active dermatological conditions on the face, including eczema, psoriasis, rosacea, acne, dermatitis, infections, wounds, sunburn, scars, or other skin disorders that may interfere with study assessments.
  5. Trial participants who have used anti-aging treatments or procedures, including retinoids, isotretinoin, topical, systemic, injectable, or device-based therapies, within 3 months prior to screening.
  6. Trial participants currently taking any medication that, in the opinion of the Investigator, may affect study results or interfere with study participation.
  7. Trial participants who have undergone facial cosmetic procedures or aesthetic treatments, including chemical peels, laser treatments, dermabrasion, microneedling, botulinum toxin injections, dermal fillers, or similar procedures within 3 months prior to screening.
  8. Trial participants currently using or having used within 1 month prior to screening oral supplements or medications known to influence skin appearance or aging (e.g., collagen supplements, biotin, antioxidant supplements, or investigational products).
  9. Trial participants with a history of keloid formation, hypertrophic scarring, poor wound healing, bleeding disorders, or active skin infection, inflammation, wounds, or other abnormal skin conditions at or near the planned biopsy site.
  10. Trial participants with a known bleeding disorder or current use of anticoagulant/antiplatelet medications that may interfere with blood collection.
  11. Trial participants who have participated in another similar clinical trial within 3 months prior to screening.
  12. Female trial participants who are pregnant, breastfeeding, or planning pregnancy during the study period.
  13. Trial participants with a history of smoking, current smoking, use of smokeless tobacco products, or a history of or ongoing alcohol or recreational drug abuse.
  14. Trial participants who are employees of the Sponsor, Contract Research Organization (CRO), or study site directly involved in the conduct of the study.
  15. Trial participants judged by the Investigator to be unsuitable for participation for any reason that may compromise participant safety, protocol compliance, or study integrity.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Food supplement placebo
The food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water. Also, a supplement placebo powder will be provided to double-mask the 2 active products
Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water.
Comparador activo: Food supplement Active
Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water.
The food supplement active supplement (2 soft gels) will be consumed once per day with a large glass of water. Also, a supplement placebo powder will be provided to double-mask the 2 active products
Comparador falso: Food supplement Comparator
The food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water. Also, a supplement placebo powder will be provided to double-mask the 2 active products
Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water. The food supplement placebo (2 soft gels) will also be consumed once per day with a large glass of water to double-mask the trial.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Skin aging hallmarks
Periodo de tiempo: 8 weeks
Change from baseline in skin hallmarks of aging (assessed on 2X2mm punch skin biopsies) after 8 weeks in a subpanel of participants
8 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidencia de eventos adversos
Periodo de tiempo: 8 semanas
8 semanas
Dermatological Assessments of Skin Health (Photo-grading using VISIA imaging)
Periodo de tiempo: 8 weeks
To evaluate and compare the efficacy of the test product with baseline and an active comparator in improving facial skin health as assessed with photoimaging (VISIA)
8 weeks
changes in circulating levels of Urolithin A in plasma samples of participants by bioanalytical assessments.
Periodo de tiempo: 8 weeks
8 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Director de estudio: Dr. Mukta Sachdev, MD, MS Clinical Research Pvt. Ltd

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

4 de agosto de 2026

Finalización primaria (Estimado)

30 de junio de 2027

Finalización del estudio (Estimado)

31 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

28 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de julio de 2026

Publicado por primera vez (Actual)

3 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • SKIN/TLSS/2026-01

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .