Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Effect of Collagen and MSM Supplementation on Advanced Glycation End Products in Skin: Part B of the TO-COSKIN4 Study (TO-COSKIN4-B)

3 novembre 2026 mis à jour par: VIST - Faculty of Applied Sciences

The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen and MSM on Advanced Glycation End Products in Skin

This nested substudy (Part B) of the VIST TO-COSKIN4 study (NCT07345195) evaluates whether 16 weeks of daily dietary supplementation with two investigational products containing collagen, methylsulfonylmethane (MSM) and vitamin C affects advanced glycation end products (AGEs) in the skin, compared with placebo. AGEs are compounds formed when sugars bind to proteins such as collagen, and they accumulate in the skin with age. They are assessed non-invasively by skin autofluorescence on the forearm. Part B includes the same participants (healthy women aged 40 to 65 years), randomisation and visits as the main study. The primary objective is to evaluate the effect of each investigational product, compared with placebo, on skin autofluorescence after 16 weeks; the secondary objective is to evaluate the effect after 8 weeks.

Aperçu de l'étude

Description détaillée

Part B is a nested substudy conducted in all participants of the VIST TO-COSKIN4 study (NCT07345195), a single-centre, randomised, double-blind, placebo-controlled, three-arm parallel-group study. Participants are allocated by the randomisation of the main study to one of two investigational products containing collagen, MSM and vitamin C, or to placebo, taken orally as 30 mL of syrup once daily for 16 weeks. Part B is described in a separate protocol annex and is analysed and reported separately from the main study.

Advanced glycation end products in the skin are assessed by skin autofluorescence, measured non-invasively with the AGE Reader on the volar forearm at baseline, week 8 and week 16. The primary endpoint is the change in skin autofluorescence from baseline to week 16, and the secondary endpoint is the change from baseline to week 8. Each investigational product is compared with placebo.

Type d'étude

Interventionnel

Inscription (Estimé)

90

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Janko Žmitek, PhD
  • Numéro de téléphone: +386 1 283 1700
  • E-mail: kozmetika@vist.si

Lieux d'étude

      • Ljubljana, Slovénie, 1000
        • VIST - Faculty of Applied Sciences, Institute of Cosmetics
        • Chercheur principal:
          • Katja Žmitek, PhD
        • Sous-enquêteur:
          • Tina Pogačnik, MSc
        • Sous-enquêteur:
          • Petra Keršmanc, MSc
        • Sous-enquêteur:
          • Manica Bevec, BSc
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

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 of 3 or less 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) below 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. more than 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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.

Autres noms:
  • Produit expérimental 1
Comparateur actif: 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.

Autres noms:
  • Produit expérimental 2
Comparateur placebo: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in skin autofluorescence from baseline to week 16
Délai: Baseline and week 16

Skin autofluorescence in arbitrary units (AU), measured with the AGE Reader on the volar surface of the dominant forearm; mean of two triple measurements per visit; each investigational product compared with placebo.

Baseline and week 16

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in skin autofluorescence from baseline to week 8
Délai: Baseline and week 8

Skin autofluorescence in arbitrary units (AU), measured with the AGE Reader on the volar surface of the dominant forearm; mean of two triple measurements per visit; each investigational product compared with placebo.

Baseline and week 8

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Katja Žmitek, PhD, VIST - Faculty of Applied Sciences

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 novembre 2026

Achèvement primaire (Estimé)

1 mai 2027

Achèvement de l'étude (Estimé)

1 mai 2027

Dates d'inscription aux études

Première soumission

3 novembre 2026

Première soumission répondant aux critères de contrôle qualité

3 novembre 2026

Première publication (Réel)

9 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • VIST TO-COSKIN4, Part B
  • Annex B to VIST TO-COSKIN4 (Autre identifiant: VIST - Faculty of Applied Sciences)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner