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.
Caucasian female volunteers aged 35 to 65 years at the time of signing the Informed Consent Form (ICF).
Signed Informed Consent Form (ICF).
Fitzpatrick skin phototypes I-IV.
Presence of visible signs of skin ageing.
Pregnancy or breastfeeding.
Vegan diet.
Heavy smoking or frequent alcohol-induced flushing.
Occupational or hobby-related excessive heat exposure (e.g. chefs, sauna workers) likely to interfere with vascular stability.
Parallel
CPMSM-HD
Dietary supplementParticipants will test continuous administration of investigational product for 16 weeks.
CPMSM-LD
Dietary supplementParticipants will test continuous administration of the investigational product for 16 weeks.
Placebo
Dietary supplementParticipants will test continuous administration of placebo product for 16 weeks.
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.
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.).
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.
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.).
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).
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VIST - Faculty of Applied Sciences
Lead sponsor
Tosla d.o.o.
Collaborator
Slovenian Research Agency
Collaborator
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