An interventional study of ColMSM-HL and Placebo syrup in Dermis Density, Wrinkles and Dermis Thickness, sponsored by VIST - Faculty of Applied Sciences. Completed at 1 site in Slovenia. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by VIST - Faculty of Applied Sciences · Not applicable, Interventional, and Treatment
The aim of the study is to compare the effects of multiple-dose 16 weeks daily dietary supplementation with 5 g or 3 g of collagen in combination with 1 g or 1.5 g of MSM and 80 mg vitamin C (see 1.2. Investigational and placebo product profile) on skin in healthy human subjects in comparison to placebo product. The main objective is to show that test products have beneficial effects on dermis density, and also on other skin parameters and to investigate differences in the effects among test products.
Single centre, randomized, double-blind, placebo-controlled, one-period effectiveness study will include 135 subjects. Subjects will be divided in five groups, 27 in each. Test group 1 (IP1 group) will receive investigational product 1 (IP1, daily dose 25 mL: collagen 5 g, MSM: 1,0 g, vitamin C: 80 mg), test group 2 (IP2 group) will receive investigational product 2 (IP2, daily dose 25 mL: collagen 3 g, MSM: 1,5 g, vitamin C: 80 mg), test group 3 (IP3 group) will receive investigational product 3 (IP3, daily dose 25 mL: collagen 3 g, MSM: 1,0 g, vitamin C: 80 mg), test group 4 (IP4 group will receive investigational product 4 (IP4, daily dose 25 mL: collagen 3 g, vitamin C: 80 mg) and the placebo group will receive placebo product without those active ingredients (25 mL: 0 g collagen, 0 g MSM). Participants will test continuous administration of placebo or investigational products for 16 weeks to demonstrate and assess multiple-dose effects.
131 studies on the registry are indexed under Erythema; 17 are open to participants now.
This study's enrollment of 139 is above the median of 50 across 114 interventional studies indexed under Erythema.
Browse Erythema studies →VIST - Faculty of Applied Sciences is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive investigational product 1 containing collagen (5 g/ 25 mL), MSM (1.0 g/ 25 mL) and vitamin C (80 mg/ 25 mL) for 16 weeks.
Dietary Supplement: ColMSM-HL
Participants will receive investigational product 2 containing collagen (3 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL), 25 mL/daily for 16 weeks.
Dietary Supplement: ColMSM-LH
Participants will receive investigational product 3 containing collagen (3 g/ 25 mL), MSM (1.0 g/ 25 mL) and vitamin C (80 mg/ 25 mL), 25 mL/daily for 16 weeks.
Dietary Supplement: ColMSM-LL
Participants will receive investigational product 4 containing containing collagen (3 g/ 25 mL) and vitamin C (80 mg/ 25 mL), 25 mL/daily for 16 weeks.
Dietary Supplement: Col-L
Placebo group participants will receive placebo syrup without active ingredients (0 mg of collagen, 0 mg of MSM and 0 mg of vitamin C), 25 mL/daily for 16 weeks.
Dietary Supplement: Placebo syrup
Participants will test continuous administration of investigational product for 16 weeks.
Also known as: Investigational product 1
Participants will test continuous administration of placebo product for 16 weeks.
Participants will test continuous administration of investigational product for 16 weeks.
Also known as: Investigational product 2
Participants will test continuous administration of investigational product for 16 weeks.
Also known as: Investigational product 3
Participants will test continuous administration of investigational product for 16 weeks.
Also known as: Investigational product 4
Change of dermis density from baseline in all test groups in comparison to placebo group after 16 weeks of dietary supplementation
Significant change of dermis density from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation with study product is expected. Dermis density will be assessed through ultrasonographic dermis intensity measurement. Differences in change of dermis density between test groups under primary objective conditions will also be evaluated.
Time frame: 16 weeks
Change of wrinkle volume from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation
Assessment of the effects of investigational product on periorbital wrinkles after 16 weeks of dietary supplementation will be done using topography measurements. Differences between test groups will also be evaluated.
Time frame: 16 weeks
Change of skin texture from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation
For assessments of skin texture topography roughness measurements (Ra) will be performed. Significant changes from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation is expected. Differences between test groups will also be evaluated.
Time frame: 16 weeks
Change of skin redness from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation
Assessment of the effects of the investigational product on skin redness after 16 weeks of dietary supplementation. Skin redness (redness score, variation and uniformity) will be measured using Antera 3D CS. Differences between test groups will also be evaluated.
Time frame: 16 weeks
Change of dermis thickness from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation
Significant change of dermis thickness from baseline in test group, in comparison to placebo group after 16 weeks of dietary supplementation with study product is expected. Dermis density will be assessed using ultrasonography. Differences between test groups will also be evaluated.
Time frame: 12 weeks
Change of skin elasticity from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation
Elasticity measurements will be performed. Significant changes from baseline in test groups in comparison to the placebo group after 16 weeks of dietary supplementation are expected. Differences between test groups will also be evaluated.
Time frame: 16 weeks
Plan to share: No
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Ran from Jan 2025 to primary completion in Jun 2025, 4 months.
Of 23 non-industry interventional studies with no phase under Erythema, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 24. This study's 4 months is below that.
Counting every sponsor, half of 43 studies reached it within 3 months; a quarter within 1 and three quarters within 11.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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VIST - Faculty of Applied Sciences