Evaluation of the Performance of a Nature-Based Sensitive Skin Regimen in Subjects With Clinically Diagnosed Sensitive Skin

August 2018 | Volume 17 | Issue 8 | Original Article | 908 | Copyright © 2018

Zoe Diana Draelos MD,a Stanley B. Levy MD,b Celeste Lutrario,c Hemali Gunt PhDc

aDermatology Consulting Services, PLLC, High Point, NC bChapel Hill Dermatology, PA, Chapel Hill, NC cBurt’s Bees, Durham, NC

Abstract

Background: Unique whole formula nature-based sensitive skin products are formulated to minimize irritation while providing conditioning and soothing benefits to clinically diagnosed sensitive skin. Objective: To evaluate and compare the efficacy and tolerability of a regimen of cleanser containing natural oils, beeswax, and witch hazel, and day & 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 clinically diagnosed sensitive skin resulting from eczema/atopic dermatitis, rosacea, or cosmetic intolerance. Methods: 120 subjects were randomized to receive either NR or CR, twice daily for 4 weeks in this double-blind study. Blinded 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 a 34% improvement from baseline in investigator-rated overall skin appearance (P less than 0.001); and CR resulted in a 4% improvement. Similar NR and CR results were found in the other efficacy parameters: tactile and visual smoothness, clarity, and radiance. Both regimens improved barrier function from baseline to week 4 (17%, 15%; NR, CR, P equals NS). NR maintained hydration from baseline to week 4 while CR increased hydration by 21% (P less than 0.001). No clinically significant tolerability issues were reported in either regimen at week 4. Conclusions: The study demonstrated that NR was effective, well tolerated, and superior to CR in the management of sensitive skin. J Drugs Dermatol. 2018;17(8):908-913.

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INTRODUCTION

Sensitive skin is a syndrome of unpleasant sensations (stinging, burning, pain, pruritus, and tingling sensations) in response to stimuli that normally do not provoke such sensations.1-3 Subjective complaints of discomfort without predictable, classical, visible signs of irritation and without an immunologic response3 contribute to a nebulous diagnosis. Yet, sensitive skin is often associated with dermatologic conditions such as rosacea, atopic dermatitis/eczema, and cosmetic intolerance syndrome.Sensitive skin warrants treatment to soothe and relieve the unpleasant sensations. Dermatologists often recommend over the counter products to soothe sensitive skin, sometimes along with prescription products, that treat the associated dermatologic condition.4 However, sensitive skin challenges dermatologists since many skin care products contain ingredients that sometimes cause allergies, irritation, exacerbate sensitive skin, or negatively affect overall skin health.5-7 Thus, often dermatologists and subjects with sensitive skin seek alternative skin care products designed to minimize redness and inflammation, improve skin barrier function, reduce dryness, and soothe hypersensitive skin while not adversely affecting skin health.8-10A new concept in skin care formulation is the creation of simple, yet efficacious, cleansers and moisturizers comprised solely of nature-based ingredients.11,12 This whole formulation approach utilizes many of the constituent ingredients of the plant rather than adding specific extracted active ingredients to synthetic bases.The goal of this study was to evaluate the effectiveness, tolerability, and physiologic performance of a nature-based sensitive skin regimen, compared with a synthetic dermatologist-recommended skin care regimen. This study is unique in that it tested the performance of NR and CR in clinically diagnosed sensitive skin.

METHODS

This IRB approved study (Concordia IRB, Beach Haven, NJ) was conducted at a single site as a randomized, double blind protocol. Test articles were blinded to both the investigator

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