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Table 1 Randomized trials of emollients for prevention of AD

From: Early intervention of atopic dermatitis as a preventive strategy for progression of food allergy

Study Year Study design Treatment/intervention Population Primary endpoints Results
Simpson et al. [50] 2014 RCT (n = 124). Treated (n = 64), untreated controls (n = 60) Various emollients: sunflower seed oil or double-base gel or liquid paraffin or Cetaphil cream or Aquaphor healing ointment
Application: Full body once a day starting within 3 weeks of birth for 6 months
Newborns at high risk for AD* Cumulative incidence of AD at 6 months AD: Statistically significant decreased risk of AD (relative risk reduction of 50%) P = 0.017
Horimukai, et al. [51] 2014 RCT (n = 118);. Intervention group (n = 59), control group (n = 59) Emulsion-type moisturizer (2e [Douhet] emulsion; Shiseido, Tokyo, Japan). Daily full body application from first week of life for 32 weeks Newborns at high risk for AD* Cumulative incidence of AD and eczema at 32 weeks AD: At week 32, AD decreased by 32% (P = 0.012) in neonates who received emulsion-based moisturizer
Yonezawa et al. [60] 2018 RCT (n = 227). Intervention group (n = 113), control group (n = 114) Pigeon Baby Milk Lotion [Pigeon] or Atopita Milky Lotion© [Tampei Pharmaceutical, Tokyo, Japan]. One or more applications per day for 12 weeks Newborns Incidence of diaper dermatitis, skin barrier function (TEWL, stratum corneum hydration, skin pH, and sebum secretion), and skin problems (redness, erythema, dryness and breakdown) at 1 and 3 months Compared with the control, the intervention group had significantly lower face TEWL (14.69 ± 7.38 vs 17.08 ± 8.26 g/m [2] per h, P = 0.033), and higher face and body stratum corneum hydration (60.38 ± 13.66 vs 53.52 ± 14.55,. P = .001) and higher body SCH (58.89 ± 12.96 vs 53.02 ± 10.08 P < 0.001). Compared with the control, newborns in the intervention group had significantly lower rates of diaper dermatitis between birth and 1 month old (6.3%vs 15.9% P = 0.022) and tended to have lower rates of body skin problems between 1 and 3 months (42.1% vs 55.2% P = 0.064)
Lowe, et al. (PEBBLES Study) [52] 2018 RCT (n = 77). Intervention group (n = 39), control group (n = 38) Ceramide-dominant
Emollient (EpiCeram®) applied twice daily to whole body for 6 months
Newborns at high risk of AD (family history of atopic disease) Incidence of AD, food sensitization at 6 and 12 months Intention-to-treat analysis showed a non-significant trend towards reduced risks of AD and food sensitization at 6 and 12 months, respectively, in the intervention group. Intention to treat analysis showed non-significant trend towards reduced risks of food sensitization at 6 (12.8 vs 22.9 P = .36) and 12 months (8.8% vs 19.4 P = 0.31). Per protocol analyses (only including infants who received ≥ 5 days/week of study treatment) revealed a significant reduction in food sensitization at 12 months in treatment group
McClanahan, et al. [53] 2019 RCT (n = 100). Intervention group (n = 54), control group (n = 46) Cetaphil® Restoraderm® (Galderma, Baie d’Urfé, Montreal, Canada). Daily full body application started with 21 days of birth through 2 years Newborns at high risk of AD Cumulative incidence of AD, filaggrin mutation analysis, skin microbiome analysis, TEWL, skin pH, stratum corneum integrity Across all clinical end points, a numerical trend was observed in favour of the intervention, although not statistically significant. A decreasing trend in AD, although not statistically significant was observed at 1 and 2 years. There were no significant differences between groups in skin barrier or microbiome assessments
Dissanayake, et al. [54] 2019 RCT (n = 549). Synbiotics plus skincare (group 1; n = 137), synbiotics only (group 2; n = 137), skincare only (group 3; n = 138), no intervention (group 4; n = 137) Group 1 received a combination of synbiotics and skincare, group 2 received synbiotics only, group 3 received skincare only, and group 4 received no intervention. Skincare product: Locobase® REPAIR Cream (Daiichi Sankyo, Japan). Synbiotics: combination of 0.5 g (7 × 109 CFU/g)of Bifidobacterium bifidumOLB6378 (Meiji Holdings Co. Ltd., Japan) combined with 0.5 g of fructo-oligosaccharides (Meiji Food Materia Co., Ltd., Japan) twice a day
Emollients applied 2–3 times a day on cheeks and the peri-oral area. The parents/guardians were allowed to apply the emollient on other parts of the body at their discretion and were not advised for or against it
Newborns AD, Sensitization to food and/or inhalant allergen at 12 months Neither the emollient nor the synbiotic showed any effect on reducing the development of AD or sensitization to food or aeroallergens at 1 year of age
Chalmers, et al. (BEEP study) [55] 2020 RTC (n = 1,394). Intervention group (n = 693), control group (n = 701) Doublebase Gel® (Dermal Laboratories Ltd.) or Diprobase Cream® (Merck Sharp & Dohme Ltd.). Daily application for 12 months Newborns at high risk of AD Incidence of AD at 12 and 24 months There were no differences in AD, food allergy or food sensitization (milk, egg, peanut), at age 2 between the control group and the intervention group. Similarly, there was no difference in other allergens (grass pollen, cat dander, or dust mite) or incidence of wheeze or allergic rhinitis at age 2
Skjerven, et al. (Prevent ADALL Study) [56] 2020 RCT (n = 2,397). Controls (n = 596), skin emollient group (n = 575), food intervention group (n = 642) skin and food intervention group (n = 583) Ceridal (GlaxoSmithKline Consumer Healthcare)
Early complementary feeding consisted of peanut, cow’s milk, wheat, and egg. Application at least 4 times a week
Newborns Incidence of AD at 12 months No statistically significant difference in AD between the control and interventional group. Neither skin emollients nor early complementary feeding reduced development of AD at 12 months
  1. *Newborns (0–3 months of age) at risk for AD are defined as having a parent or full sibling who has (or had) physician diagnosed AD, asthma, or allergic rhinitis