Efficacy of Topical Botanical Treatment of Children With Mild to Moderate Atopic Dermatitis
October 2019 | Volume 18 | Issue 10 | Original Article | 1038 | Copyright © October 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, NY;
Indiana Medical Center, Indianapolis, IN; Physicians Skin Care, PLLC,; DermResearch, PLLC, Louisville, KY
Abstract
Objective: The study was conducted to determine the efficacy of the botanical combination incorporated in Kamedis Eczema Therapy Cream (the test product) for children with mild to moderate atopic dermatitis.
Design: The study was designed as an interventional, multi-center, double-blind, randomized, controlled study.
Setting: Children subjects were a sub-population of the 108 combined population of adults and children evenly randomly divided into three treatment groups: test product, vehicle, and comparator. The vehicle used was the identical test product without the botanical combination while the comparator was a leading OTC brand in the US market. All three groups used the same Kamedis body wash followed by one of the three randomized treatment creams for the affected areas.
Participants: Thirty-nine (39) children subjects with uncomplicated, stable, mild to moderate atopic dermatitis were recruited and qualified for the study, 24 female and 15 male, ages varying between 3 and 18.
Measurements: Investigators assessed the severity of each subject using the Investigator Global Assessment (IGA), affected Body Surface Area (BSA) extent evaluated parameters at each of the visit days 0, 7, 14, and 28. Subjective symptoms of pruritus and insomnia were evaluated by the patient or their legal guardian. The SCORAD and EASI indexes were calculated based on the collected parameters.
Results: The test product demonstrated an improvement in all evaluated and calculated clinical parameters over the vehicle at the end of the treatment duration, proving the validation that the test product is much more effective and beneficial than the vehicle. The test product reached 40% of 'clear' IGA subjects out of the enrolled subjects and 60% out of the 'clear' and 'almost clear' IGA subjects comparing to 8% and 38%, respectively, with the vehicle, presenting a clear advantage over the vehicle. The BSA improvement comparison analysis of the test product over the vehicle yielded P value of less than 0.05, which is statistically significant. The SCORAD and EASI indexes also showed an advantage of the test product versus the vehicle at week 4.
Conclusion: The study results validate that the botanical combination is the key factor for the efficacy and improvement of the AD symptoms within this population of children.
J Drugs Dermatol. 2019;18(10):1038-1045.
INTRODUCTION
Atopic dermatitis (AD) is a common chronic inflammatory skin disease and the most common chronic skin disease in children, with a lifetime prevalence of 10-20%.1 AD usually appears in early infancy and is characterized by pruritus and erythematous papules.2 In severe cases, intense pruritus and scratching may lead to secondary infection.1 AD is usually associated with other atopic diseases (asthma, allergic rhinitis). The clinical pattern of AD varies with age. The childhood phase typically occurs from 2 years of age to puberty. Although AD is a chronic disease, it resolves in about 60% of patients before adulthood.3 In 45% of children, the onset of AD occurs during the first 6 months of life, during the first year of life in 60%, and before the age of 5 years in at least 85% of affected children. In those children with onset before the age of 2 years, 20% of the population will have persisting manifestations of AD, and 17% of them on the other hand will experience intermittent symptoms by the age of 7 years. Older children are less likely to have the exudative lesions commonly seen in infancy and instead exhibit more lichenified papules and plaques representing the severity of the chronic disease and involving the hands, feet, wrists, ankles, and antecubital and popliteal regions.4
