Validation of Botanical Treatment Efficiency for Adults and Children Suffering from Mild to Moderate Atopic Dermatitis

June 2019 | Volume 18 | Issue 6 | Original Article | 557 | Copyright © June 2019

Zoe Diana Draelos MD,a Michael Traub ND FABNO,b Michael H. Gold MD,c Lawrence J. Green MD,d Mark Amster MD,e Deganit Barak-Shinar PhD,f Leon H. Kircik MDg

aDermatology Consulting Services, PLLC, High Point, NC bHawaii Integrative Oncology Ho’o Lokahi, Kailua Kona, HI cTennessee Clinical Research Center, Nashville, TN dGeorge Washington University School of Medicine, Washington, DC eMetro Boston Clinical Partners, LLC, Boston, MA fKamedis Ltd. Tel-Aviv, Israel gIcahn School of Medicine at Mount Sinai, New York, NY; Indiana University Medical Center, Indianapolis, IN; Physicians Skin Care, PLLC; DermResearch, PLLC; Skin Sciences, PLLC, Louisville, KY.

Abstract
Objective: The study was conducted to determine the efficiency of the botanicals combination incorporated in the Kamedis Eczema Therapy Cream (the tested product) for adults and children suffering from mild to moderate Atopic Dermatitis.

Design: The study designed as an interventional, multi-center, double-blind, randomized, controlled study. Setting: Subjects were evenly randomly divided into three treatment groups: tested product, vehicle, and comparator. The vehicle used was the identical tested product without the botanical combination while the comparator was a leading OTC brand in the US market. All three above groups used a similar Kamedis wash for the body and face following by one of the three randomized treatment creams for the affected areas on the face and body.

Participants: One hundred and eight (108) subjects with uncomplicated, stable, mild to moderate atopic dermatitis recruited and qualified for the study; 71 females and 37 males, age 3 to 73.

Measurements: The investigator assessed the severity of each subject using the Investigator Global Assessment (IGA) and affected body surface area (BSA) at each of the visit days 0, 7, 14, and 28.

Results: The tested product demonstrated an improvement in IGA and BSA over the vehicle at every visit across treatment time, proving the validation that the botanical product is much more effective and beneficial than the same product without the botanicals. The tested product as well as the comparator reached exactly the same percentage, 34%, of 'clear' IGA subjects of the enrolled subjects, presenting advantage over the vehicle. The BSA improvement comparison analysis of the tested product over the vehicle yielded statistically significant P value of 0.0369.

Conclusion: The study results approve and validate that the botanical combination is the key factor for the efficacy and improvement of the AD symptoms within this study population.

J Drugs Dermatol. 2019;18(6):557-561.

INTRODUCTION

Atopic dermatitis (AD) is a common chronic inflammatory skin disease with a lifetime prevalence of 10-20% in children and 1-3% in adults.1 AD usually starts in early infancy and is typified by pruritus, erythematous papulovesicular lesions, xerosis (dry skin), and lichenification of the skin.2 In severe cases, intense pruritus (itching) and scratching may lead to secondary infection.1 AD is usually associated with other atopic diseases as asthma and other allergic reactions.

Without an understanding of the complex and multifactorial pathogenesis of AD, treatment can be difficult and often unsatisfactory. When the structural integrity of the outer skin layer is compromised by injuring the aggregation of keratin filaments supporting the skin barrier, as in a mutation, pathogens, or allergens, toxins are able to pass through the hyperpermeable barrier, and create chronic inflammation.3-5

Currently, there is no cure for the disease. Management of AD focuses on controlling the severity and duration of AD symptoms. In mild to moderate cases, treatment includes reduction of exposure to triggering factors and topical application of emollients and steroid-free barrier creams as well as topical corticosteroids. In more severe cases, the condition is often treated with systemic corticosteroids and immunosupressive