Efficacy and Tolerability of Low Molecular Weight Hyaluronic Acid Sodium Salt 0.2% Cream in Rosacea

June 2013 | Volume 12 | Issue 6 | Original Article | 664 | Copyright © June 2013


Todd E. Schlesinger MD FAADa and Callie Rowland Powell BSN RNb

aMedical Director, Dermatology and Laser Center of Charleston, PA, Charleston, SC
bClinical Research Coordinator, Dermatology and Laser Center of Charleston, PA, Charleston, SC

Abstract
OBJECTIVE: Rosacea is a chronic cutaneous disorder characterized by flushing, erythema, telangiectasia, edema, papules, and pustules. The cause of this inflammatory disorder is unknown, but is thought to be multifaceted. Primary treatments for rosacea are typically oral antibiotics and topical therapies. Hyaluronic acid sodium salt cream 0.2% is a topical device containing low molecular weight hyaluronic acid (LMW-HA) that is effective in normalizing the cutaneous inflammatory response. The objective of this study was to evaluate the efficacy and safety of hyaluronic acid sodium salt cream 0.2%.
DESIGN and SETTING: Prospective, observational, non-blinded efficacy and tolerability study in an outpatient setting.
PARTICIPANTS: Individuals 18 to 75 years of age with mild to moderate facial rosacea.
MEASUREMENTS: Outcome measures included papules, pustules, erythema, edema, telangiectasia, burning or stinging, dryness and provider global assessment (PGA), which were all measured on a five-point scale. Subjects were assessed at baseline, week 2, week 4, and week 8.
RESULTS: Final data for 14 of 15 subjects are presented. Through visual grading assessments, hyaluronic acid sodium salt cream 0.2% was shown to improve the provider global assessment by 47.5 percent from baseline to week 4. Reductions in papules, erythema, burning or stinging, and dryness were 47, 51.7, 65, and 78.8 percent, respectively at week 4. At week 8, the provider global assessment was improved from baseline in 78.5 percent of subjects.
CONCLUSION: Improvement was noted in measured clinical parameters with use of topical low molecular weight hyaluronic acid. Topical low molecular weight hyaluronic acid is another option that may be considered for the treatment of rosacea in the adult population. Compliance and tolerance were excellent. Consideration should be given to use for individuals with rosacea characterized by an erythematous and/or papular component.

J Drugs Dermatol. 2013;12(6):664-667.

INTRODUCTION

Rosacea is a chronic cutaneous disorder that is usually found on the face. The disorder is most commonly characterized by flushing, erythema, telangiectasia, edema, papules, and pustules.1 The cause of this inflammatory disorder is unknown, but is thought to include multiple contributing factors. Treatment regimens for rosacea commonly include oral antibiotics, which may cause problematic side effects such as anaphylaxis, photosensitivity, and superinfections. 2 Physicians are constantly searching for innovative treatment options for rosacea, especially those capable of replacing the need for oral antibiotic therapy.
A polysaccharide that is found in skin tissue is hyaluronic acid.3 As high molecular weight hyaluronic acid (HMW-HA) is depolymerized in sites of inflammation or tissue injury, low molecular weight hyaluronic acid (LMW-HA) fragments result. Low-molecular weight hyaluronic acid fragments are hydrophilic, allowing them to penetrate the stratum corneum.4 In addition, LMW-HA has the ability to alter the innate immune response partly stimulating the production of cytokines and chemokines by macrophages and activating T cells and dendritic cells. Effects on cell behavior include leukocyte, fibroblast, and endothelial cell migration and activation.5 The combination makes LMWHA an asset to dermatologic care, having implications in wound care. The benefits of LMW-HA do not end with wound care and may extend to the treatment of inflammatory skin disorders such as seborrheic dermatitis and rosacea.6 LMW-HA interacts with collagen and fibrin and serves as a building block for proteoglycans in the extra cellular matrix. Such interactions affect cell motility, proliferation, and recognition, as well as angiogenesis and the actions of inflammatory cells. Lastly, LMW-HA induces the production of β-defensin 2 (DEFβ2) by stimulating a tissue injury response, ultimately creating an antibacterial effect that allows for regeneration of the cutaneous epithelium and reduction in antigen load. Current research shows a reduction in healing time, edema, and pain, as well as improved appearance and cicatrization with use of LMW-HA.4

METHODS

Beginning in February 2012, a single-site, unblinded, prospective, observational study of hyaluronic acid sodium salt cream 0.2% (Bionect Cream, Innocutis Holdings, Charleston, South Carolina) for the treatment of facial rosacea was conducted. The final subject completed the 8-week visit in August 2012. The study consisted of a single cohort to which all adult subjects were assigned. The trial was conducted in accordance with the
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