Table 2.
Randomized Trials Assessing at Least One Ceramide-containing Emollient for Atopic Dermatitis
| Prevention type | RCT Author & Study Name | Participant Number & Study Arms | Population | Emollient | Duration, Frequency, & Location | Outcome measures | Results |
|---|---|---|---|---|---|---|---|
| 1ry | Yonezawa K, et al. Effects of moisturizing skincare on skin barrier function and the prevention of skin problems in 3-month-old infants: A randomized controlled trial157 |
227 Control group: 113 Intervention group: 114 |
1 week to 3 months of age | For bathing, Pigeon Baby Soap [Pigeon, Tokyo, Japan] or Kewpie Baby Body Soap, Cow Brand Soap [Kyoshinsh a, Tokyo, Japan] As moisturizer in intervention group: Pigeon Baby Milk Lotion [Pigeon] or Atopita Milky Lotion© [Tampei Pharmace utical, Tokyo, Japan] |
12 weeks Application 1–2x daily with bathing every 2 days in intervention group Vs Daily bathing without moisturizer in control group |
1 ry: TEWL, SCH, skin pH and sebum secretion at 3 months of age 2ndry: Incidence of skin problems (e.g. Diaper dermatitis) at 3 months of age |
Statically significant lower TEWL (mean ± SD, 14.69 ± 7.38 vs 17.08 ± 8.26 g/m2 per h, P = 0.033) and higher face SCH (60.38 ± 13.66 vs 53.52 ± 14.55, P = 0.001) and higher body SCH (58.89 ± 12.96 vs 53.02 ± 10.08, P < 0.001) in intervention vs. control group Diaper dermatitis at 1–3 months of age significantly lower in intervention vs. control group (6.3% vs 15.9%, P = 0.022; RRR= 0.399 [95% confidence interval [CI], 0.174–0.919]). Skin problems at 1–3 months of age significantly lower in intervention vs. control group (42.1% vs 55.2%, P = 0.064; relative risk ratio, 0.762 [95% CI, 0.569–1.021]). Risk of dry facial skin was reduced with intervention by 48.4% (relative risk ratio, 0.516; 95% CI, 0.333–0.799]) Risk of dry body skin was reduced with intervention by 39.7% (relative risk ratio, 0.603; 95% CI, 0.399–0.911) |
| 1ry | Eric Simpson A Community-based Assessment of Skin Care, Allergies, and Eczema (CASCADE) NCT03409367 |
1250 2 arms |
Up to 2 months of age Born at > 25 weeks of gestation |
Choice of over the counter lipid-rich emollient (Vaseline/Vanicream/Cerave Healing Ointment/Cerave cream/Cetaphil cream) | 24 months Once daily full body application |
1ry: Cumulative incidence of AD at 24 months of age 2ndry: AD diagnosed by Children’s Eczema Questionnaire (CEQ) at 12 and 24 months Any prescription topical medication or over-the-counter hydrocortisone usage Parental report at 3, 6, 9, 12, 15, 18 and 24 months of provider-diagnosed AD and sleep loss of infant Parental report of immediate food allergy symptoms or a provider diagnosis of food allergy that was confirmed by prick testing or IgE blood test at 12 and 24 months Asthma risk using a modification of the asthma predictive index (API) at 12 and 24 months Global Health Status using one question from the PROMIS PGH-7 instrument at 12 and 24 months Atopic dermatitis severity as measured by parental report of eczema, age of onset Time to onset of AD as measured by provider-recorded date of first diagnosis retrieved from review of health record AD symptom severity as reported by POEM Atopic dermatitis severity by Parent-reported global severity of eczema assessment IDQoL instrument |
Study ongoing- no results published to date. |
| 1ry | Dissanayake et al. Skin care and synbiotics for prevention of AD or FA in newborn infants: A 2 × 2 factorial, randomized, non-treatment controlled trial160 |
605 pregnant women recruited - 549 infants enrolled Randomized into 4 treatment arms:
|
Infants | Locobase ® REPAIR cream (Daiichi Sankyo, Japan) | 6 months 2–3x daily |
1ry: Development of AD at 1 year of age 2ndry: Prevalence of FA, as reported in the questionnaires at 1 year Sensitization to any food or inhalant allergen at 9 months of age EASI score at 9 months of age TARC score at 9 months of age |
Cumulative incidence of AD (itchy skin condition lasting 2 or more months) at 12 months of age: 30.9% in group 1, 32.1% in group 2, 38.6% in group 3, and 25.6% in group 4 – No statistically significant difference Incidence of AD AS DEFINED BY UKWPC was 20.4% in group 1, 14.7% in group 2, 21.0% in group 3, and 18.8% in group 4 – No statistically significant difference No statistically significant difference in AD incidence after adjusting for emollient application rate (80% of the parents/guardians in the emollient groups applied emollient at least 2x/day) No statistically significant difference in AD rate when comparing group 1+3 (received emollients) to 2+4 (no emollients) TARC levels not significantly different between all infants of all groups TARC levels of infants who developed AD by 9 months of age also not significantly different between all groups EASI scores showed mild disease in most babies who developed AD by 9 months of age (only 5/49 babies with AD had moderate disease) Highest EASI score was 13.6. Median scores did not differ significantly among groups Prevalence of FA at 1 year of age, sensitization to any food or inhalant allergen at 9 months of age and allergen-specific IgE showed no difference in AD incidence between groups |
| 1ry | Lowe A, Su J, Tang M, et al. PEBBLES study protocol: RCT to prevent AD, FA and sensitization in infants with a family history of allergic disease using a skin barrier improvement strategy172 Phase III ACTRN12617001380381 NCT03667651 |
760 2 arms (380 in each) |
Up to 3 weeks of age 1st degree relative has a self-reported hx of AA, AD, hay fever/AR or FA |
EpiCeram® | 6 months 6 grams 2x daily |
1ry: Presence of AD in first 12 months of life assessed using UKWP criteria and/or visible AD at time of examination 2ndry: FA, based on skin prick tests, hx of reactions & OFC (if wheel ≥ 1 mm) at 12 months Adverse events (AEs) to EpiCeram® Skin barrier function as assessed by TEWL at 6 weeks & 12 months Food sensitization (positive skin prick test) at 12 months of age |
Study ongoing- no results published to date. |
OFC: oral food challenge; RCT: Randomized controlled trial; TARC: Thymus and activation-regulated chemokine