Table 2.
Summary of studies of emollient use in neonates, infants, children, and adults with AD.
| Study population | Treatment | Study duration | Efficacy | Safety |
|---|---|---|---|---|
| Neonates | ||||
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| Neonates (N = 22) at high risk for AD [124] | Petrolatum-based emollient barrier cream (Cetaphil, Galderma Laboratories, Fort Worth, TX, USA) | At least once daily for up to 2 years | Observed cases: 15% developed AD. Intent-to-treat: 23% developed AD | No adverse events related to treatment |
|
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| Infants | ||||
|
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| Infants with moderate-to-severe AD, age <12 months (N = 173) [120] | Oat extract-containing emollient (Exomega, Laboratories Pierre Fabre, France) | Twice daily for 6 weeks | Significantly reduced use of high-potency topical corticosteroids and improved SCORAD index and QoL | Good/Very good tolerance in 94% of infants at study end. Two serious adverse events |
|
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| Children | ||||
|
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| Children with mild-to-moderate AD, age 2 months–6 years (N = 25) [79] | Occlusive colloidal oatmeal cream and colloidal oatmeal glycerin cleanser (AVEENO, JOHNSON and JOHNSON Consumer Companies, Inc., Skillman, NJ, USA) | Cream: twice daily for 4 weeks. Cleanser: all bathing | Significantly improved IGA scores, dryness, roughness, and mean itch scores at 2 and 4 weeks. Significantly improved QoL scores at 4 weeks | Well tolerated; no serious adverse events related to treatment |
| Children with mild-to-moderate AD, age 3 months–16 years (N = 65) [125] |
Ceramide-dominant barrier emulsion (EpiCeram) | Twice daily for 3 weeks | Improved IGA, patient satisfaction, and QoL | No serious adverse events related to treatment |
| Children with AD, age 6 months–12 years (N = 76) [85] |
Moisturizer milk (Exomega) versus control | Twice daily for 2 months | Significantly improved xerosis, pruritus, and QoL | Tolerance rated as satisfactory or excellent in 97% |
| Children with mild-to-moderate AD, age 6 months–12 years (N = 142) [114] |
Glycyrrhetinic acid-based cream (Atopiclair) versus vehicle | Three times daily for 43 days | Significantly improved IGA, reduced use of rescue medication (topical corticosteroid) | No serious adverse events related to treatment |
| Children with moderate-to-severe AD, age 6 months–18 years (N = 121) [87] |
Ceramide-dominant barrier emulsion (EpiCeram) versus fluticasone cream (Cutivate, PharmaDerm, Melville, NY, USA) | Twice daily for 28 days | Significantly improved SCORAD index. Comparable efficacy between treatment arms | No serious adverse events related to treatment |
| Children with stubborn-to-recalcitrant AD, age 1.5–12.0 years (N = 24) [116] |
Ceramide-dominant barrier emollient (TriCeram, Osmotics Corp, Denver, CO, USA) replaced prior moisturizer. Topical tacrolimus or corticosteroid was continued | Twice daily for 12 weeks, then once daily for 9 weeks | Significantly improved SCORAD in 92% of patients by 3 weeks, 100% by 21 weeks; decreased TEWL; improved SC hydration and integrity | No serious adverse events related to treatment |
| Children with mild-to-moderate AD, age 2–17 years (N = 39) [122] | Glycyrrhetinic acid-based cream (Atopiclair) versus ceramide-based barrier cream (EpiCeram) versus petrolatum-based ointment (Aquaphor Healing Ointment, Beiersdorf Inc, Wilton, CT, USA) | Three times daily for 3 weeks | All treatment arms improved, with no significant difference between treatments. Petrolatum-based ointment had greatest improvement across assessments | Well tolerated; no serious adverse events related to treatment |
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| Adults | ||||
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| Children to adults with mild-to-moderate AD, age 2–70 years [123] (Study 1, N = 66; study 2, N = 127) |
Cetaphil Restoraderm moisturizer (Galderma Laboratories, Fort Worth, TX, USA) | Study 1: Twice daily for 4 weeks; study 2: twice daily for 4 weeks as adjuvant treatment with topical steroid | Study 1: significantly decreased itching and improved hydration and QoL. Study 2: versus steroid only: significantly improved hydration, decreased EASI scores and faster onset of action | No serious adverse events related to treatment |
| Adolescents to adults with mild-to-moderate AD, age 12–60 years (N = 25) [80] | Oat-based occlusive cream and oatmeal-glycerin body wash (AVEENO) | Cream: twice daily for 8 weeks. Wash: once daily | Significantly improved: EASI and IGA scores at 2, 4, and 8 weeks; QoL at 4 and 8 weeks | Well tolerated; no serious adverse events related to treatment |
| Adults with mild-to-moderate AD, age >16 years (N = 30) [111] | Glycyrrhetinic acid-based cream (Atopiclair) versus vehicle | Three times daily for 3 weeks | Significantly improved itch and EASI scores symptoms | No serious adverse events related to treatment |
| Adults with mild-to-moderate AD, age 2–70 years (N = 2456) [119] |
PEA-containing barrier (MimyX) | Twice daily for 4–6 weeks | Significantly improved symptoms versus baseline, reduced use of topical corticosteroids | No serious adverse events related to treatment |
| Adults with AD (N = 197) [121] | 20% glycerin versus cream base control versus cream with 4% urea + 4% sodium chloride | Once daily for 30 days | Similar improvements in dryness | Moderate-to-severe stinging in 10% of glycerin group and 24% of urea/saline group |
| Adults with mild-to-moderate AD (N = 24) [115] | 20% glycerin emollient versus placebo | Twice daily for 4 weeks | Improved SC hydration, restored epidermal barrier function (TEWL) | Not reported |
| Adults with allergic contact dermatitis, irritant contact dermatitis, or AD (N = 580) [112] | Ceramide-3 plus patented nanoparticles with or without corticosteroids | Once or twice daily until clearance (8 weeks) | Significantly improved symptoms in both treatment arms. Significantly improved pruritus, erythema, fissuring, and overall severity in combination arm | Not reported |
| Adults with mild-to-moderate AD (N = 100) [113] | 5% urea moisturizer versus 10% urea lotion twice daily | Twice daily for 42 days | Similar reduction in SCORAD from baseline, no difference between products | Both products well tolerated; 5 adverse events possibly related to study treatment; 3 patients withdrew from study because of adverse events |
| Adults with mild-to-moderate AD (N = 60) [117] | Mineral oil, petrolatum, and paraffin-based moisturizer (Albolene) versus barrier cream MimyX (plus 0.1% triamcinolone cream for moderate AD) | Twice daily for 4 weeks | No difference between treatment groups in clinical efficacy | No serious adverse events related to treatment |
| Adults with mild-to-moderate AD (N = 20) [118] | Hyaluronic acid-based emollient foam (Hylatopic, Onset Therapeutics, Cumberland, RI, USA) versus ceramide-containing barrier cream (EpiCeram) | Twice daily for 4 weeks | Significantly improved symptoms at weeks 2 and 4 for foam; at week 4 for cream. Patients preferred foam | No serious adverse events related to treatment |
| Adults with mild-to-moderate AD (N = 218) [110] | Glycyrrhetinic acid-based cream (Atopiclair) versus vehicle | Three times daily for 3 weeks | Significantly improved EASI and IGA, and reduced rescue medication | No serious adverse events related to treatment |
AD: atopic dermatitis; SCORAD: scoring atopic dermatitis index; QoL: quality of life; IGA: investigator global assessment; TEWL: transepidermal water loss; SC: stratum corneum; EASI: eczema area and severity index; PEA: palmitoylethanolamide.