- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07925437
Effect of Collagen and MSM Supplementation on Advanced Glycation End Products in Skin: Part B of the TO-COSKIN4 Study (TO-COSKIN4-B)
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
Statut
Les conditions
Intervention / Traitement
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
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Katja Žmitek, PhD
- Numéro de téléphone: +386 1 283 1700
- E-mail: katja.zmitek@vist.si
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
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Ljubljana, Slovénie, 1000
- VIST - Faculty of Applied Sciences, Institute of Cosmetics
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Chercheur principal:
- Katja Žmitek, PhD
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Sous-enquêteur:
- Tina Pogačnik, MSc
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Sous-enquêteur:
- Petra Keršmanc, MSc
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Sous-enquêteur:
- Manica Bevec, BSc
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Contact:
- Katja Žmitek, PhD
- Numéro de téléphone: +386 1 283 1700
- E-mail: katja.zmitek@vist.si
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
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
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 |
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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:
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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:
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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 |
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Change in skin autofluorescence from baseline to week 16
Délai: Baseline and week 16
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in skin autofluorescence from baseline to week 8
Délai: Baseline and week 8
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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
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Katja Žmitek, PhD, VIST - Faculty of Applied Sciences
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
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) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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