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

NCT07345195 | Not Yet Recruiting

• 1 other identifier: VIST TO-COSKIN4 12-2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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 human subjects 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 objective is to evaluate the effect of the investigational products on facial telangiectasiae severity. Other skin parameters will be assessed as supportive endpoints, and differences in efficacy between the two investigational formulations will also be evaluated.

Conditions

Erythema; Telangiectasis; Skin Redness

Keywords

Facial telangiectasiae; Erythema; Facial erythema; Collagen; MSM; Dietary supplement; Skin health; Skin redness; Erythema-prone skin

Outcome Measures

Primary Outcomes (4)

• Change of redness score from baseline in test groups in comparison to placebo group after 16 weeks of dietary supplementation

  Assessment of the effects of the investigational products on redness score after 16 weeks of dietary supplementation will be assessed using Antera 3D CS, as a 0-100 score. Differences between test groups will also be evaluated.

  16 weeks

• Change of redness variation from baseline in test groups in comparison to placebo group after 16 weeks of dietary supplementation

  Assessment of the effects of the investigational products on redness variation after 16 weeks of dietary supplementation will be assessed using Antera 3D CS in arbitrary units (a.u.).

  16 weeks

• Change of hemoglobin hyperconcentration area from baseline in test groups in comparison to placebo group after 16 weeks of dietary supplementation

  Assessment of the effects of the investigational products on the hemoglobin hyperconcentration area after 16 weeks of dietary supplementation will be assessed using Antera 3D CS in mm². Differences between test groups will also be evaluated.

  16 weeks

• Change of hemoglobin hyperconcentration intensity from baseline in test groups in comparison to placebo group after 16 weeks of dietary supplementation

  Assessment of the effects of the investigational products on the hemoglobin hyperconcentration intensity after 16 weeks of dietary supplementation will be assessed using Antera 3D CS in arbitrary units (a.u.).

  16 weeks

Secondary Outcomes (1)

• Change of visibility of facial telenagiectasiae from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation

  16 weeks

Study Arms (3)

IP1 group

ACTIVE COMPARATOR

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

ACTIVE COMPARATOR

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 COMPARATOR

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

Interventions

CPMSM-HD DIETARY_SUPPLEMENT

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

Also known as: Investigational product 1

IP1 group

CPMSM-LD DIETARY_SUPPLEMENT

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

Also known as: Investigational product 2

IP2 group

Placebo DIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasian female volunteers aged 35 to 65 years at the time of signing the Informed Consent Form (ICF).
• Signed Informed Consent Form (ICF).
• Fitzpatrick skin phototypes I-IV.
• Presence of visible signs of skin ageing.
• Presence of visible facial telangiectasias, primarily on the cheeks.
• Presence of facial erythema with a baseline score ≤ 3 on the 5-point Clinical Erythema Assessment (CEA) scale.
• 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 throughout the study.
• Not initiate or modify oestrogen or progesterone therapies during the study.
• Maintain the same cosmetic and skincare routine and comply with sun protection guidelines throughout the study.
• Avoid rejuvenation treatments during the study.
• Refrain from consuming food supplements containing collagen or other protein-based supplements, methylsulfonylmethane (MSM), or anti-inflammatory and/or antioxidant compounds with a known or potential impact on skin inflammation or vascular response for the duration of the study.

You may not qualify if:

• Pregnancy or breastfeeding.
• Vegan diet.
• Heavy smoking or frequent alcohol-induced flushing.
• Occupational or hobby-related excessive heat exposure (e.g. chefs, sauna workers) likely to interfere with vascular stability.
• 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
• Hormonal therapy (contraception or hormone replacement therapy)
• Methylsulfonylmethane (MSM);
• Collagen or other protein-based supplements;
• Anti-inflammatory supplements (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.
• 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, including but not limited to acne, perioral dermatitis, psoriasis, atopic dermatitis, or lupus.

Sponsors & Collaborators

• Slovenian Research Agency: collaborator
• VIST - Faculty of Applied Sciences: lead
• Tosla d.o.o.: collaborator

Study Sites (1)

VIST - Faculty of Applied Sciences, Institute of Cosmetics

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Erythema; Telangiectasis

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Katja Žmitek, PhD

  Head of Reasearch Group

  STUDY DIRECTOR

Central Study Contacts

Katja Žmitek, PhD

CONTACT

0038612831700; katja.zmitek@vist.si

Janko Žmitek, PhD

CONTACT

0038612831700; kozmetika@vist.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 15, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)