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| Name | Class |
|---|---|
| Tosla d.o.o. | INDUSTRY |
| Slovenian Research and Innovation Agency | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IP1 group | Active Comparator | 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. |
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| IP2 group | Active Comparator | 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. |
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| IP3 group | Active Comparator | 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. |
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| IP4 group | Active Comparator | 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. |
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| 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), 25 mL/daily for 16 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ColMSM-HL | Dietary Supplement | Participants will test continuous administration of investigational product for 16 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 16 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katja Žmitek, PhD | Head of Reasearch Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VIST - Faculty of Applied Sciences, Institute of Cosmetics | Ljubljana | 1000 | Slovenia |
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| ID | Term |
|---|---|
| D004890 | Erythema |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| Placebo syrup | Dietary Supplement | Participants will test continuous administration of placebo product for 16 weeks. |
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| ColMSM-LH | Dietary Supplement | Participants will test continuous administration of investigational product for 16 weeks. |
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| ColMSM-LL | Dietary Supplement | Participants will test continuous administration of investigational product for 16 weeks. |
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| Col-L | Dietary Supplement | Participants will test continuous administration of investigational product for 16 weeks. |
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| 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. | 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. | 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. | 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. | 16 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |