Natural Skin Care Products as Adjunctive to Prescription Therapy in Moderate to Severe Rosacea

February 2019 | Volume 18 | Issue 2 | Original Article | 141 | Copyright © 2019

Zoe Diana Draelos MD,a Hemali Gunt PhD,b Stanley B. Levy MDc

aDermatology Consulting Services, PLLC High Point, NC; bBurt's Bees, Durham, NC cChapel Hill Dermatology, Chapel Hill, NC

Abstract

Background: Rosacea is characterized by irritation associated with erythema, telangiectasias and papules/pustules. Whole formula nature-based sensitive skin products are formulated to maintain skin barrier and appropriate hydration that can lead to soothing benefits. Objective: To evaluate the efficacy and tolerability of a regimen consisting of a cleanser containing natural oils, beeswax, and witch hazel and day and night creams containing natural oils, glycerin, and botanical anti-inflammatories (NR); and a synthetic dermatologist-recommended regimen of cetyl alcohol, sodium lauryl sulphate-containing cleanser, and glycerin, polyisobutene-containing lotion (CR) in subjects with rosacea. Methods: 80 female subjects with rosacea who received 6 weeks of 0.75% metronidazole gel, were randomized to receive NR or CR, twice daily, for 4 weeks in conjunction with the gel. Blinded investigator global assessment of rosacea, investigator-rated, and subject-rated overall skin appearance was assessed using a 5-point scale (0=none, 4=severe) at baseline, 2 weeks, and 4 weeks. Noninvasive skin assessments for skin hydration and skin barrier function were made by corneometry and TEWL, respectively. Results: NR resulted in improvement in investigator global assessment of rosacea measures at 4 weeks from baseline (erythema, 28%; telangiectasia, 26%; papules/pustules, 34%: P less than 0.001) and CR resulted in a 8 to 12% improvement. Differences between treatments were statistically significant. Overall skin appearance measured by the investigator was clinically and statistically improved from baseline by 32% and 12% with NR and CR, respectively. Overall skin appearance measured by subjects was improved by both NR and CR from baseline with no differences between treatments. Both regimens improved barrier function from baseline to week 4 (13%, NR; 14%, CR). NR decreased hydration by 21% from baseline at week 4 while CR increased hydration by 14% (P less than 0.001 from NR). No clinically significant tolerability issues were reported in either regimen at week 4. Conclusion: NR was effective, well tolerated, and superior to CR in the management of rosacea, concomitantly treated with metronidazole. National Clinical Trial Identifier: NCT03392558 J Drugs Dermatol. 2019;18(2):141-146.

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INTRODUCTION

Rosacea is a challenging dermatological condition due to its multifactorial causes.1 Diet, environment, menopause, mites, bacteria, cathelicidins, and improper skin care have all been implicated as contributing causes of the pathognomonic red face. Successful rosacea treatment usually combines many different activities to minimize the facial inflammation.2,3 Dermatologists frequently provide rosacea patients with a "trip wire list" of foods to avoid, including chocolate, coffee, tea, aged cheeses, red wine, etc., and skin care product recommendations along with oral or topical prescription medications. Current first line topical medication used for rosacea, based on cost and insurance formulary availability, is typically metronidazole 0.75% gel twice daily.4 The dermatologist must then pick a skin care regimen that optimizes the effect of the topical antimicrobial while repairing and maintaining the skin barrier.5 Selecting skin care products can be challenging, as the consumer market is broad and confusing,5 with few properly powered well-designed studies to provide data. This research aimed to better understand the role of moisturizers and cleansers in moderate to severe rosacea patients who had undergone treatment with metronidazole 0.75% gel twice daily for 4 weeks prior to initiating a new skin care regimen. Dermatologist investigator and subject assessments accompanied by facial photography and noninvasive instrumental evaluations were collected to better understand the effect of skin care on prescription therapy over a 10-week period.

METHODS

80 female subjects between 25-70 years of age possessing Fitzpatrick skin types I-III with facial rosacea who signed consent (Concordia Institutional Review Board; Cedar Knolls, NJ) and met all inclusion and none of the exclusion criteria were enrolled in this 10-week single site controlled product-blinded study. Subjects who were pregnant, nursing, or used antiaging skin care products within 4 weeks of study entry were eliminated, as were those who possessed a sensitivity to any of the

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