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| Name | Class |
|---|---|
| Tosla d.o.o. | INDUSTRY |
| Slovenian Research Agency | OTHER |
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The aim of the randomized, double-blind, placebo-controlled, one-period effectiveness study is to compare the effects of multiple-dose 16 weeks daily dietary supplementation with 5 g collagen alone or 5 g of collagen in combination with hyaluronic acid 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 84 subjects. Subjects will be divided in three groups, 28 in each. Test group 1 (TG1) will receive investigational product 1 (CP5HA, daily dose 15 mL: collagen 5 g, hyaluronic acid (HA): 30 mg, vitamin C: 80 mg), test group 2 (TG2) will receive investigational product 2 (CP5, daily dose 15 mL: collagen 5 g, vitamin C: 80 mg) and the placebo group (PG) will receive placebo product without those active ingredients (15 mL: 0 g collagen, 0 g HA, 0 g vitamin C). Participants will test continuous administration of placebo or investigational products for 16 weeks in order to demonstrate and assess multiple-dose effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group 1 (CP5HA Group) | Active Comparator | Participants will receive investigational product 1 containing collagen (5 g/ 15 mL), hyaluronic acid (30 mg/ 15 mL) and vitamin C (80 mg/ 15 mL). |
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| Placebo group | Placebo Comparator | Placebo group participants will receive placebo syrup without active ingredients. (daily dose 15 mL: collagen: 0 mg, HA: 0 mg, vitamin C: 0 mg); continous administration of placebo product for 12 weeks. |
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| Test group 2 (CP5 Group) | Active Comparator | Participants will receive investigational product 2 containing collagen (5 g/ 15 mL) and vitamin C (80 mg/ 15 mL). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP5HA | Dietary Supplement | Test group 1 will receive investigational product 1 containing collagen (5 g/ 15 mL), hyaluronic acid (30 mg/ 15 mL) and vitamin C (80 mg/ 15 mL); continuous administration of investigational product for 16 weeks. |
| 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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| Placebo syrup | Dietary Supplement | Placebo group will receive placebo syrup without active ingredients. (daily dose 25 mL: collagen: 0 mg, MSM: 0 mg, vitamin C: 0 mg; continous administration of placebo product for 16 weeks. |
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| CP5 | Dietary Supplement | Test group 2 will receive investigational product 2 containing collagen (5 g/ 15 mL) and vitamin C (80 mg/ 25 mL); 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, Rq) 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 hydration 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 hydration after 16 weeks of dietary supplementation. Skin hydration measurements will be performed using conductance principle. 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. | 16 weeks |
| Change of skin elasticity from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation | Significant change of skin elasticity from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation with study products is expected. Skin elasticity will be assessed using viscoleasticity measurement (Units of Measure: MPa). Differences between test groups will also be evaluated. | 16 weeks |