A Split-Face Study Assessing the Clinical Benefit, Tolerability and Subject Satisfaction of a Dermocosmetic in Subjects with Rosacea Associated with Erythema and Sensitive Skin
Received 2 July 2020
Accepted for publication 8 September 2020
Published 5 October 2020 Volume 2020:13 Pages 751—758
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 5
Editor who approved publication: Dr Jeffrey Weinberg
Enzo Berardesca,1 Adriana Bonfigli,2 Bernard Cribier,3 Frederic Flament,4 Marco Vicic,4 Delphine Kerob,5 Jerry Tan6
1Phillip Frost Department of Dermatology, University of Miami, Miami, FL, USA; 2ISPE, Milano, Italy; 3Clinique Dermatologique, University Hospital, Strasbourg, France; 4L’Oréal Research and Innovation, Chevilly-Larue, France; 5Laboratoires Vichy International, Levallois-Perret, France; 6Western University, Department of Medicine and Windsor Clinical Research Inc, Windsor, ON, Canada
Correspondence: Enzo Berardesca
Phillip Frost Department of Dermatology, University of Miami, Miami, FL, USA
Tel +1 393486962500
Objective: This study assessed the efficacy and tolerability of M89 in patients with rosacea associated with erythema and sensitive skin.
Methods: Intra-individual study in a split-face design comparing after 30 days M89 twice daily and usual skin care in 20 adult subjects with rosacea and sensitive skin. M89 contains 89% Vichy volcanic mineralizing water (VVMW) and 0.4% hyaluronic acid. It is hypoallergenic and contains no perfume and this convenes in rosacea. Contained minerals reinforce the natural defences of the skin in restoring the natural skin barrier, stimulating antioxidant activity and reducing inflammation, commonly observed in subjects with rosacea. Clinical evaluations included assessment of erythema, desquamation, papules and pustules, skin tightness, dryness, burning sensation, itching, stinging and stinging test as well as local tolerability. Instrumental evaluations included skin hydration and TEWL. Subject satisfaction was assessed at Days 15 and 30. Demodex density was assessed at Day 30.
Results: A significant superiority of M89 over the standard skin care was observed for erythema, skin tightness and dryness (all P≤ 0.05) as early as Day 15, the skin stinging test was significantly in favour of M89 (P< 0.05 at Day 15 and P< 0.01 at Day 30) and for skin hydration (P< 0.0001) at Day 15 and 30 with no difference in mean Demodex density between M89 and usual skin care after 30 days. Tolerance was excellent and subject satisfaction very high.
Conclusion: Study results concerning M89 are encouraging for its use either alone or as an adjuvant daily skin care to topical medication in patients with persistent centrofacial erythema of rosacea with no more than 3 papules and pustules.
Keywords: rosacea, sensitive skin, Vichy volcanic mineralizing water, M89, split face
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