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Not Yet RecruitingNCT07345195

The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen and MSM on Facial Erythema and Other Skin Parameters

The Effect of 16-week Dietary Intake of Food Supplements Containing Collagen and MSM on Facial Erythema and Other Skin Parameters: Double Blind, Placebo-controlled, Randomised Three-way Study Comparing the Efficacy of Two Test Products

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
90 (estimated)
Sponsor
VIST - Faculty of Applied Sciences · Academic / Other
Sex
Female
Age
35 Years – 65 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTCPMSM-HDParticipants will test continuous administration of investigational product for 16 weeks.
DIETARY_SUPPLEMENTCPMSM-LDParticipants will test continuous administration of the investigational product for 16 weeks.
DIETARY_SUPPLEMENTPlaceboParticipants will test continuous administration of placebo product for 16 weeks.

Timeline

Start date
2026-01-01
Primary completion
2026-09-01
Completion
2026-11-01
First posted
2026-01-15
Last updated
2026-01-15

Locations

1 site across 1 country: Slovenia

Source: ClinicalTrials.gov record NCT07345195. Inclusion in this directory is not an endorsement.