A Randomized, Controlled Clinical Trial of a Dermocosmetic Containing Vichy Volcanic Mineralizing Water and Probiotic Fractions in Subjects with Rosacea Associated with Erythema and Sensitive Skin and Wearing Protective Masks

Abstract

Purpose

Rosacea is a common facial dermatosis, with flares induced by exposome factors. M89PF containing Vichy mineralizing water, probiotic fractions, hyaluronic acid, niacinamide and tocopherol repairs the skin barrier and reinforces skin defences against exposome factors. This study assessed the benefit of M89PF in subjects with rosacea associated with erythema and sensitive skin during the Covid-19 pandemic using protective face masks.

Methods

M89PF was compared to usual skin care in a randomized, split-face study, for 30 days in subjects with rosacea associated with erythema and sensitive skin. Clinical evaluations included erythema, desquamation, skin tightness, dryness, burning sensation, itching, stinging, stinging test, and local tolerability. Instrument evaluations included erythema, skin hydration and TEWL. Subject satisfaction was also assessed.

Results

Erythema significantly improved with M89PF at both time points (p<0.01 at D15, and p<0.001 at D30). Skin sensitivity assessed by the skin stinging test improved significantly (p<0.01) with M89PF at D30, compared to baseline and usual skin care. Skin erythema, tightness, dryness, hydration and TEWL significantly improved (p≤0.05) with M89PF at D15 and D30, versus baseline and the untreated side. Subjects were highly satisfied with M89PF at D15 and D30. Tolerance was very good in all subjects.

Conclusion

In subjects with rosacea, M89PF significantly reduces erythema, skin tightness, dryness and TEWL, and improves skin hydration and skin sensitivity, even when using protective masks. M89PF is well tolerated and received high satisfaction ratings.

ClinicalTrials.gov. No

NCT05562661.

Keywords:

• rosacea
• skin barrier
• exposome
• erythema
• sensitive skin

Data Sharing Statement

Enzo Berardesca, the corresponding author will share upon reasonable request for 1 year after publication of this manuscript the study protocol and all data collected and statistically analysed and in relationship with this study, except deidentified participant data.

Acknowledgments

The authors acknowledge the editorial assistance of Karl Patrick Göritz, Scientific and Medical Writing Services, France.

Disclosure

Adriana Bonfigli and Claudia Cartigliani are affiliated with ISPE. Delphine Kerob is an employee of Cosmetic Active International, France (a L’Oreal company). Jerry Tan is an advisor, consultant and speaker for Cosmetic Active International, France (a L’Oreal company). He also reports personal fees from Vichy, during the conduct of the study; personal fees from La Roche Posay, Vichy, and Galderma, outside the submitted work. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study was funded by Laboratories Vichy International, a L’Oreal company.