- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07345195
El Efecto de la Ingesta Dietética de 16 Semanas de Suplementos Alimenticios que Contienen Colágeno y MSM sobre el Eritema Facial y Otros Parámetros de la Piel (TO-COSKIN4)
Efecto de la ingesta dietética durante 16 semanas de suplementos alimenticios que contienen colágeno y MSM sobre el eritema facial y otros parámetros cutáneos: estudio triple ciego, controlado con placebo, aleatorizado y de tres vías que compara la eficacia de dos productos de prueba
The aim of this study is to compare the effects of 16 weeks of daily dietary supplementation with two investigational products containing collagen, methylsulfonylmethane (MSM), and vitamin C on skin parameters in comparison to a placebo product. The study will be conducted in healthy women aged 40 to 65 years with visible facial erythema and telangiectasiae (cheeks), stable for ≥3 months, without active rosacea. The primary objective is to demonstrate beneficial effects of the investigational products on facial erythema. The secondary objectives are to evaluate the effect on facial erythema after 8 weeks and the effects on telangiectasiae severity and other redness-related skin parameters. Other skin parameters will be assessed as supportive endpoints, and differences between the two investigational formulations will also be explored.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a single-centre, randomized, double-blind, placebo-controlled, one-period effectiveness study designed to evaluate the effects of multiple-dose, daily dietary supplementation over a 16-week period on skin parameters in healthy women aged 40 to 65 years. The study population consists of subjects with visible facial erythema and telangiectasiae predominantly on the cheeks, stable for at least 3 months prior to inclusion, and without clinical signs of active rosacea.
Eligible participants will be randomized to receive one of two investigational products or a placebo product, administered as a daily oral dose of 30 mL for 16 consecutive weeks. The investigational products contain the following compositions: Investigational Product 1 (IP1): collagen 10 g, methylsulfonylmethane (MSM) 2.0 g, and vitamin C 160 mg; and Investigational Product 2 (IP2): collagen 5 g, MSM 1.5 g, and vitamin C 160 mg.
The primary objective of the study is to evaluate whether 16 weeks of supplementation with the investigational products results in a beneficial effect on facial erythema compared with placebo. The secondary objectives are to assess the effect on facial erythema after 8 weeks and the effects on telangiectasiae severity and other redness-related skin parameters. Supportive objectives include the evaluation of additional skin parameters; differences between the two investigational formulations will also be explored.
All participants also take part in a nested substudy (Part B), registered separately, assessing advanced glycation end products in the skin.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Katja Žmitek, PhD
- Número de teléfono: 0038612831700
- Correo electrónico: katja.zmitek@vist.si
Copia de seguridad de contactos de estudio
- Nombre: Janko Žmitek, PhD
- Número de teléfono: 0038612831700
- Correo electrónico: kozmetika@vist.si
Ubicaciones de estudio
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Ljubljana
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Ljubljana, Ljubljana, Eslovenia, 1000
- Reclutamiento
- VIST - Faculty of Applied Sciences, Institute of Cosmetics
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Contacto:
- Katja Zmitek, PhD
- Número de teléfono: 002831700
- Correo electrónico: katja.zmitek@vist.si
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Investigador principal:
- Katja Žmitek, PhD
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Sub-Investigador:
- Tina Pogačnik, MSc
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Sub-Investigador:
- Petra Keršmanc, MSc
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Sub-Investigador:
- Sara Jereb, MSc
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Sub-Investigador:
- Manica Bevec, BSc
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Caucasian female volunteers aged 40 to 65 years at the time of signing the Informed Consent Form (ICF).
- Signed ICF.
- Fitzpatrick skin phototypes I-IV.
- Presence of visible facial telangiectasias, primarily on the cheeks.
- Presence of facial erythema with a baseline score <= 3 on the 5-point Clinician's Erythema Assessment (CEA) scale.
- Stable erythema-prone facial skin for at least 3 months prior to inclusion, without clinical signs of active rosacea.
- In good general health, as determined by medical history.
- Body mass index (BMI) < 35.
- Willingness and ability to comply with all study procedures and complete a subject diary; maintain usual lifestyle habits; not initiate or modify oestrogen or progesterone therapies; maintain the same cosmetic and skincare routine and comply with sun protection guidelines; avoid rejuvenation treatments; refrain from food supplements containing collagen or other protein-based supplements, MSM, or anti-inflammatory and/or antioxidant compounds with a known or potential impact on skin inflammation or vascular response; and refrain from shaving, waxing, epilating or otherwise removing hair from the forearms for the duration of the study.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- Vegan diet.
- Following a weight-loss diet or another special or restrictive diet (e.g. very-low-calorie, ketogenic or intermittent fasting), or planning to start one during the study.
- Heavy smoking (more than 20 cigarettes per day) or frequent alcohol-induced flushing.
- Occupational or hobby-related excessive heat exposure (e.g. chefs, sauna workers).
- Anticipated sunbathing or solarium use, or major planned changes in sun exposure before or during the study.
- Planned major changes during the study in skincare routine or hormonal therapy (contraception or hormone replacement therapy).
- Significant changes in dietary habits or dietary supplementation within 3 months prior to inclusion.
- Regular use within 3 months prior to inclusion of food supplements containing MSM, collagen or other protein-based supplements, or anti-inflammatory (e.g. bioflavonoids/rutin, curcumin, EPA) and/or antioxidant supplements with a known or potential impact on skin inflammation or vascular response.
- Any diagnosed, uncontrolled, untreated or unstable medical condition.
- Clinically significant history of metabolic, gastrointestinal, hepatic, renal or haematological disease.
- Diagnosed diabetes mellitus (type 1 or type 2), or current use of glucose-lowering medication.
- Current use, or use within 12 months prior to study entry, of medicines for weight reduction, including GLP-1 receptor agonists and dual GIP/GLP-1 receptor agonists, or planned use during the study.
- Mental incapacity or psychiatric condition that may impair understanding of the study or compliance with study requirements.
- Any clinically significant acute or chronic inflammatory skin disease (e.g. acne, perioral dermatitis, psoriasis, atopic dermatitis, lupus).
- Skin pigmentation disorders at the assessment sites.
- Active rosacea within 3 months prior to study entry (papules/pustules, frequent flushing episodes typical of rosacea, or ocular involvement).
- Frequent vasomotor hot flushes (e.g. perimenopausal or menopausal).
- Use of medications affecting skin or vascular reactivity (e.g. systemic corticosteroids, anticoagulants, vasodilators, antibiotics known to affect vascular response, immunomodulators, regular or long-term use of NSAIDs).
- Use of systemic retinoids within 3 months prior to study entry.
- Changes of skincare routine within 4 weeks prior to study entry.
- Use of highly concentrated topical products affecting inflammatory or vascular facial responses (e.g. >15% azelaic acid, 10% vitamin C) within 4 weeks prior to study entry.
- Invasive rejuvenation treatments (e.g. medium or deep chemical peels, ablative or vascular laser therapies) within 6 months prior to study entry.
- Non-invasive or minimally invasive rejuvenation treatments (e.g. microneedling, mesotherapy, superficial chemical peels, radiofrequency, electrotherapy, ultrasound, IPL) within 3 months prior to study entry.
- Tattoos, scars, birthmarks, pronounced hyperpigmentation, visible vessels, or an active skin lesion or skin disease at the volar forearm of both forearms.
- Self-tanning products applied to the forearms, or deliberate UV exposure of the forearms (sunbathing, solarium), within 4 weeks before the first visit.
- Known or suspected allergy to any ingredient of the investigational products.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: IP1 group
Participants will receive investigational product 1 containing collagen (10 g/ 30 mL), MSM (2.0 g/ 30 mL) and vitamin C (160 mg/ 30 mL) for 16 weeks. |
Participants will test continuous administration of investigational product for 16 weeks.
Otros nombres:
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Comparador activo: IP2 group
Participants will receive investigational product 2 containing collagen (5 g/ 30 mL), MSM (1.5 g/ 30 mL) and vitamin C (160 mg/ 30 mL) for 16 weeks. |
Participants will test continuous administration of the investigational product for 16 weeks.
Otros nombres:
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Comparador de placebos: Placebo group
Placebo group participants will receive placebo syrup without active ingredients (0 mg of collagen, 0 mg of MSM and 0 mg of vitamin C), 30 mL/daily for 16 weeks. |
Participants will test continuous administration of placebo product for 16 weeks. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in facial erythema (redness - average) from baseline to week 16
Periodo de tiempo: From baseline to end of intervention at 16 weeks
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Redness - average in arbitrary units (a.u.), Antera 3D CS multispectral imaging; each investigational product compared with placebo. |
From baseline to end of intervention at 16 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in haemoglobin hyper-concentration from baseline to week 16
Periodo de tiempo: From baseline to end of intervention at 16 weeks
|
Haemoglobin hyper-concentration (a.u.), Antera 3D CS, as a measure of facial telangiectasiae severity; each investigational product compared with placebo; also assessed at week 8. |
From baseline to end of intervention at 16 weeks
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Change in redness - variation from baseline to week 16
Periodo de tiempo: From baseline to end of intervention at 16 weeks
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Redness - variation (a.u.), Antera 3D CS, as a measure of the variability (unevenness) of facial redness; also assessed at week 8. |
From baseline to end of intervention at 16 weeks
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Change in skin colour (delta a*) from baseline to week 16
Periodo de tiempo: From baseline to end of intervention at 16 weeks
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Delta a* (CIELAB red-green axis), Antera 3D CS |
From baseline to end of intervention at 16 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in dermis density from baseline to week 16
Periodo de tiempo: From baseline to end of intervention at 16 weeks
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Dermis intensity (0-100), 20 MHz ultrasonography (Cortex DermaLab), volar forearm |
From baseline to end of intervention at 16 weeks
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Change in dermis thickness from baseline to week 16
Periodo de tiempo: From baseline to end of intervention at 16 weeks
|
Dermis thickness (µm), 20 MHz ultrasonography (Cortex DermaLab), volar forearm; |
From baseline to end of intervention at 16 weeks
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Change in skin elasticity (R2) from baseline to week 16
Periodo de tiempo: From baseline to end of intervention at 16 weeks
|
Skin elasticity parameter R2, volar forearm measured with Cortex DermaLab |
From baseline to end of intervention at 16 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Katja Žmitek, PhD, Head of Reasearch Group
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- VIST TO-COSKIN4 12-2025
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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