ErythemaTO-COSKIN4NCT07345195
The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen and MSM on Facial Erythema and Other Skin Parameters
A study testing CPMSM-HD and CPMSM-LD in people with Erythema and Telangiectasis, run by VIST - Faculty of Applied Sciences at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Erythema, Telangiectasis, Skin Redness
- What is being tested?
- CPMSM-HD and CPMSM-LD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSlovenia
- Study dates
- 16 Nov 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site
VIST - Faculty of Applied Sciences, Institute of Cosmetics
Ljubljana, Ljubljana, 1000
Katja Zmitek, PhD, 002831700, katja.zmitek@vist.si
Katja Žmitek, PhD
About this study
Official title: The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen and MSM on Facial Erythema and Other Skin Parameters: Double Blind, Placebo-controlled, Randomised Three-way Study Comparing the Efficacy of Two Test Products
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.
Read the detailed description
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.
- Conditions
- Erythema, Telangiectasis, Skin Redness
- Being tested
- CPMSM-HD, CPMSM-LD, Placebo
- Keywords
- Facial telangiectasiae, Erythema, Facial erythema, Collagen, MSM, Dietary supplement, Skin health, Skin redness, Erythema-prone skin
- Medical subject headings
- Erythema, Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPMSM-HDDietary supplement
Also called Investigational product 1
Participants will test continuous administration of investigational product for 16 weeks.
CPMSM-LDDietary supplement
Also called Investigational product 2
Participants will test continuous administration of the investigational product for 16 weeks.
PlaceboDietary supplement
Participants will test continuous administration of placebo product for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in facial erythema (redness - average) from baseline to week 16
Redness - average in arbitrary units (a.u.), Antera 3D CS multispectral imaging; each investigational product compared with placebo.
Measured: From baseline to end of intervention at 16 weeks
Secondary outcomes (3)
Change in haemoglobin hyper-concentration from baseline to week 16
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.
Measured: From baseline to end of intervention at 16 weeks
Change in redness - variation from baseline to week 16
Redness - variation (a.u.), Antera 3D CS, as a measure of the variability (unevenness) of facial redness; also assessed at week 8.
Measured: From baseline to end of intervention at 16 weeks
Change in skin colour (delta a*) from baseline to week 16
Delta a* (CIELAB red-green axis), Antera 3D CS
Measured: From baseline to end of intervention at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start16 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErythemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VIST - Faculty of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Tosla d.o.o., Slovenian Research Agency
- Responsible party
- Sponsor
- Investigators
- Katja Žmitek, PhD, Study director, Head of Reasearch Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345195
- Sponsor's protocol ID
- VIST TO-COSKIN4 12-2025
- Acronym
- TO-COSKIN4
- Status last verified
- Oct 2026
- First submitted
- 24 Dec 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen and MSM on Facial Erythema and Other Skin Parameters: Double Blind, Placebo-controlled, Randomised Three-way Study Comparing the Efficacy of Two Test Products
- ClinicalTrials.gov ID
- NCT07345195
- Acronym / sponsor ID
- TO-COSKIN4 / VIST TO-COSKIN4 12-2025
- Conditions
- Erythema, Telangiectasis, Skin Redness
- Keywords
- Facial telangiectasiae, Erythema, Facial erythema, Collagen, MSM, Dietary supplement, Skin health, Skin redness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- VIST - Faculty of Applied SciencesUniversity, hospital or other
- Collaborators
- Tosla d.o.o., Slovenian Research Agency
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IP1 group | Active comparator | Dietary Supplement: CPMSM-HDParticipants 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. |
| IP2 group | Active comparator | Dietary Supplement: CPMSM-LDParticipants 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. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (27 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPMSM-HDAlso: Investigational product 1Participants will test continuous administration of investigational product for 16 weeks. | Dietary supplement | IP1 group |
| CPMSM-LDAlso: Investigational product 2Participants will test continuous administration of the investigational product for 16 weeks. | Dietary supplement | IP2 group |
| PlaceboParticipants will test continuous administration of placebo product for 16 weeks. | Dietary supplement | Placebo group |
Primary outcome
Change in facial erythema (redness - average) from baseline to week 16
Time frame: From baseline to end of intervention at 16 weeks
Redness - average in arbitrary units (a.u.), Antera 3D CS multispectral imaging; each investigational product compared with placebo.
3 secondary outcomes
Change in haemoglobin hyper-concentration from baseline to week 16
Time frame: From baseline to end of intervention at 16 weeks
Change in redness - variation from baseline to week 16
Time frame: From baseline to end of intervention at 16 weeks
Change in skin colour (delta a*) from baseline to week 16
Time frame: From baseline to end of intervention at 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katja Žmitek, PhD study director
Head of Reasearch Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPMSM-HD and CPMSM-LD in people with Erythema and Telangiectasis, run by VIST - Faculty of Applied Sciences at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katja Žmitek, PhD (0038612831700, katja.zmitek@vist.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in facial erythema (redness - average) from baseline to week 16 (time frame: From baseline to end of intervention at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.