A decrease in skin microbial diversity, particularly an over-abundance of Staphylococcus aureus colonization, is observed on AD lesional skin, plus is associated with disease severity and skin barrier dysfunction.19-21 In children, lack of skin microbiome diversity was shown to be present during AD flares, and to precede disease clinical diagnosis.22,23
Several studies have evaluated the efficacy of emollients on preserving skin barrier integrity and maintaining bacterial diversity for AD symptom management.21,24-26 In AD patients, Seite et al. demonstrated that emollient treatment significantly reduced erythema, dryness, and desquamation on lesional skin, plus restored skin microbiome composition comparable to normal skin after 84 days.21 Additionally, prebiotic emollient containing Vitreoscilla filiformis (Vf) lysate, a Gram-negative nonpathogenic bacterium with anti-inflammatory and antioxidant properties, showed to decrease AD-related pruritus, severity, and transepidermal water loss (TEWL), plus normalized skin microbiota by reducing S. aureus abundance in AD patients.27-30 Recently, prebiotic emollients were demonstrated to decrease the usage frequency of topical corticosteroid in patients with mild to moderate AD, as well as reducing pruritus in moderate to severe AD patients under systemic therapy.31,32 These studies support the recommendation European AD guidelines of using emollients 'plus' in AD patients, which correspond to emollients supplemented with active ingredients and non-medicated substances.33,34 Together, these findings highlight the benefits of prebiotic skincare in AD management and the role of microbiome for healthy skin barrier.
Racial/ethnic variations in AD prevalence and severity, plus clinical phenotypes and endophenotypes, including S. aureus colonization have been reported.4-12,35,36 Despite higher prevalence and persistence, particularly in children, SOC patients are under-represented in AD clinical trials.37 Additionally, limited studies exist on the benefits of adjunctive emollients in the management of AD in SOC individuals.26,37 In this study, we evaluated the efficacy of a prebiotic skincare routine, consisting of a cleanser and moisturizer, in improving mild AD and severe xerosis, plus impact on quality-of-life in ethnically diverse US patients.
MATERIALS AND METHODS
Study Participants
The study was performed in accordance with Good Clinical Practices and the principles of the Declaration of Helsinki. The procedures used in this study were approved by Allendale Institutional Review Board (Old Lyme, CT). Before any study procedure, the subjects received the necessary written and verbal information and signed an informed consent form. Eligibility was determined by physical examination and confirmation of all inclusion/exclusion criteria. A total of hundred and forty (140) subjects from diverse racial/ethnic backgrounds, aged 3-80 years old with skin phototypes I-VI, and presenting with mild AD or moderate to severe xerosis completed study. Subjects with history of allergy, hypersensitivity, or any serious reaction to any cosmetic product; or any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator were excluded.
Test Materials
The prebiotic cleanser (Lipikar AP+ Gentle Foaming Cleansing Oil) contained niacinamide, shea butter, glycerin and La Roche-Posay thermal spring water. The prebiotic moisturizer (Lipikar AP+M Moisturizing Cream) contained ceramide, shea butter, niacinamide, glycerin, Aqua posae filiformis (APF, a lysate of Vf grown in La Roche-Posay thermal spring water), plus Microresyl.
Study Design
After dermatological evaluations, all subjects started using a prebiotic cleanser alone for 2 weeks, followed by using a prebiotic moisturizer in adjunct for an additional 8 weeks. All subjects were given diaries to record daily frequency and time of product applications, plus any observations. Evaluations included clinical and instrumental assessments, quality-of-life questionnaires, plus clinical imaging at baseline (week 0), weeks 2, 4, 8, and 10.
