ReclutandoNCT07345195Registro de ClinicalTrials.gov

The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen and MSM on Facial Erythema and Other Skin Parameters

Erythema · Telangiectasis · Skin Redness

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De qué trata este estudio

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Tipo de estudio: De intervención
Fase: No aplica
Rango de edad: 40 años - 65 años
Sexo admitido: Femenino
Voluntarios sanos: Aceptados
Participantes: 90 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

Leer la descripción completa

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento cuádruple

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.

Dietary Supplement: CPMSM-HD

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.

Dietary Supplement: CPMSM-LD

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.

Dietary Supplement: Placebo

CPMSM-HD DIETARY_SUPPLEMENT

Participants will test continuous administration of investigational product for 16 weeks.

CPMSM-LD DIETARY_SUPPLEMENT

Participants will test continuous administration of the investigational product for 16 weeks.

Placebo DIETARY_SUPPLEMENT

Participants will test continuous administration of placebo product for 16 weeks.

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