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A Preliminary Clinical Evaluation of a Topical Product for Reducing Slight Rosacea Imperfections

Authors Maggioni D, Cimicata A, Praticò A, Villa R, Bianchi FM, Busoli Badiale S, Angelinetta C

Received 5 December 2019

Accepted for publication 29 March 2020

Published 21 April 2020 Volume 2020:13 Pages 299—308


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Jeffrey Weinberg

Daniele Maggioni,1 Annamaria Cimicata,1 Antonella Praticò,1 Roberta Villa,1 Ferdinando Marco Bianchi,1,2 Silvia Busoli Badiale,1 Claudio Angelinetta1

1Bio Basic Europe Srl, Milan, Italy; 2Dermo-Cosmetic and Medical R&D Center of Bio Basic Europe Srl, Milan, Italy

Correspondence: Annamaria Cimicata Tel +39 02 4155729
Fax +39 0242174243

Introduction: Rosacea is a chronic multifactorial skin disorder mainly affecting facial skin with an estimated prevalence of about 5% worldwide. Its main symptoms, occurring early during pathology development, are skin dehydration, redness, erythema, and telangiectasia. Given the lack of a resolutive cure, therapeutic approaches able to relieve the main symptoms are needed.
Purpose: The aim of this research article is to evaluate the beneficial effect of a topical product (Serum BK46) on rosacea symptoms.
Patients and Methods: A monocentric single-arm, non-blinded study was performed to assess the clinical effect of Serum BK46 in relieving the main symptoms of rosacea: skin dryness, increased trans epidermal water loss (TEWL), redness, and abnormal vascularization. Twenty patients with mild to moderate rosacea were enrolled in the study and asked to apply the product twice per day for 56 days. Skin moisturization, TEWL, and erythema index were instrumentally assessed at baseline and following 24 h and 14, 28 and 56 days of treatment. Clinical parameters, including redness and telangiectasia imperfection visibility, were evaluated on a 5-point scale by a specialized dermatologist at baseline and after 14, 28, and 56 days of treatment. Finally, the visibility of vessel diameter was evaluated at baseline and after 28 and 56 days of treatment.
Results: Serum BK46 application restored skin hydration and prevented the loss of water by the skin. Long-term treatment with Serum BK46 significantly reduced skin redness, erythema index, and the visibility of telangiectasia imperfections and superficial vessels. The investigated product’s clinical effect was demonstrated by both instrumental and clinical evaluation. Furthermore, Serum BK46 was completely tolerated and no adverse effects were recorded.
Conclusion: The moisturizing and skin barrier restoring action of Serum BK46 has been clearly proven in patients displaying mild to moderate rosacea; thus, this product is a good candidate for rosacea treatment.

Keywords: rosacea, topical product, transepidermal water loss, skin redness, telangiectasia

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