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.
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 human subjects. 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 objective is to assess the effect of the investigational products on facial telangiectasiae severity. Supportive objectives include the evaluation of additional skin parameters and the assessment of differences in efficacy between the two investigational formulations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Participants will test continuous administration of investigational product for 16 weeks.
Participants will test continuous administration of the investigational product for 16 weeks.
Participants will test continuous administration of placebo product for 16 weeks.
VIST - Faculty of Applied Sciences, Institute of Cosmetics
Ljubljana, Slovenia
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.
Time frame: 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.).
Time frame: 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.
Time frame: 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.).
Time frame: 16 weeks
Change of visibility of facial telenagiectasiae from baseline in test groups, in comparison to placebo group after 16 weeks of dietary supplementation
The effects of the investigational product on facial telangiectasia after 16 weeks of dietary supplementation will be assessed using expert evaluation using Telangiectasia in Rosacea Severity Assessment (TRoSA) scale on a 0-4 grade (0 - No visible telangiectasia, 4 - Extensive, dense, and highly visible telangiectasia involving a large surface area).
Time frame: 16 weeks
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