Table I.
Studies included in the systematic review
| References | Study Design (SC or MC, RCT, blinded, other information) | Treatment: Name of steroid, potency and vehicle (class) | Placebo: Vehicle/moisturizer | Frequency of application | Duration of treatment (days) | Number ITT, n per protocol In final analysis (n intervention, n control group), | Age Range in months (mean), comments | AD severity, % male, % Race/Ethnicity | Potential Conflicts of Interest | Number of Responders to therapy Intervention, Control; Primary outcomes assessed (1,2 or 3) & primary outcome reported in this column)$ | Number of Participants >=1 AE Intervention, Control |
|---|---|---|---|---|---|---|---|---|---|---|---|
| (Udompatai kul and Limpa-o-vart 2012) | SC Thailand, RCT, single blind participant, comparative effectiveness, placebo & steroid on different arms at same time | Hydrocortisone 1% ointment (VII) | 5% Dexapantheno l ointment | BID | 28 | 30, 26 (26,26) | 2–180 (86) | Mild/moderate, 38%, 100% Asian | Bayer provided dexpanthenol ointment | 26, 26 (1,2,3 & 1,2,3) | 0, 0 |
| (Sudilovsk y, Muir et al. 1981) | MC USA, RCT, double blind, comparison study, placebo & steroid on different arms at same time | Halcinonide 0.10% cream (II) | Vehicle | QD | 21 | 58, 58 (58,58) | 9–1032 (not reported) | Not reported | Funded by Squibb Institute | 33, 10 (1 & 1) | Not reported |
| Wu (Wu, Chen et al. 2013) | SC China, RCT, double blind, parallel group comparison study | Mometasone furoate 0.1% cream (II) | Vehicle mixed with distilled water in 1% DMSO | BID | 10 | 40, 36 (19,17) | 1–12 (4) | All severities, 64%, 100% Asian. | Funded by Medical Emphasis grant from government of Jiangsu Province, People’s republic of China. | 19, 17 (1,2,3 & 1,2,3) | 0, 0 |
| (Wolkerstorfer, Visser et al. 2000) | SC Netherlands, RCT, unspecified blinding | Fluticasone propionate 0.05% cream diluted, open weave cotton wet wraps applied on top (V) | Vehicle | QD | 7–14 | 8, 8 (6,2) | 5–156 (not reported) | Moderate/severe , 48%, Not reported | Funding source not listed. | 5, 0 (2 & 2) | 2, 2 |
| (Sugarman and Parish 2009) | MC USA, RCT, triple blind | Fluticasone propionate 0.05%, cream (III) | Ceramide-dominant triple lipid barrier repair formulation (epiceram) | BID | 28 | 121, 112 (59,53) | 6–216 (91) | Moderate/severe , 40%, 26% White, 56% Black, 3% Asian, 9% Hispanic, 6% Other | Funded by Ceragenix corporation. | 27, 21 (3 & 3) | 0, 4 |
| (Abramovit s and Oquendo 2010) | MC USA, RCT, double blind | Hydrocortisone butyrate 0.1% lipocream (V) | Lipocream vehicle | BID | 21–29 | 264, 247 (131,133) | 3–204 (85) | Mild/moderate, Not reported | Sponsor initiated investigation | 82, 37 (1 & 1) | 29, 28 |
| (Matheson, Kempers et al. 2008) | MC USA, RCT, triple blind, parallel group | Hydrocortisone butyrate 0.1%, lotion (V) | Vehicle | BID | 28 | 284, 252 (139,145) | 3–216 (86), 33% <2 years | Mild/moderate, 50%, 65% White, 32% Black, 5% Asian, 1% Other* | Funded by Ferndale Laboratories, authors compensated for the study. | 68, 35 (1 & 1) | 48, 56 |
| (Hanifin, Gupta et al. 2002) | MC USA & Canada, RCT, double bind, we analyzed data only from maintenance phase of study when placebo compared | Fluticasone propionate 0.05%, cream (V) | Vehicle | QD (4 days/week for 4 weeks) then QD (2 days/week for 16 weeks) | 140 | 247, 231 (154,77) | 3–204 (85), 24% <2 years | Moderate/severe#, 44%, 64% White, 16% Black, 14% Asian, 6% Other | Funded by Glaxo Wellcome, Inc. | 112, 26 (1 & 1) | 71, 29 |
| (Stalder, Fleury et al. 1994) | SC France, RCT, double blind | Desonide 0.1%, cream (III) | Polyoxyethyle ne glycol mixed stearate with other additives | QD | 7 | 40, 39 (18,21) | 4–180 (40) | Not reported, 55%, Not reported | Funding source not specified, but one of the authors works at Pierre Fabre laboratories. | 12, 3 (3 & 3) | Not reported |
| (Rauschkol b, Bender et al. 1981) | MC USA, RCT, double blind, paired comparison, place & steroid on different arms at the same time | Halcinonide 0.025% cream (IV) | Placebo cream unspecified | TID | 14 | 86, 79 (79,79) | 7–180 (96) | Not reported, 38%, 70% White, 29% Black, 1% Asian | Funded by Squibb and Sons, Inc. | 64, 40 (1 & 1) | 4, 5 |
| (Hebert, Cook-Bolden et al. 2007) | RCT USA, MC, double blind, phase III study | Desonide 0.05%, gel (VI) | Hydrogel vehicle | BID | 28 | 582, 541 (425,157) | 3–216 (80), 30% <3years | Mild/Moderate, 45%, 53% White, 28% Black, 4% Asian, 12% Hispanic, 3% Other. | Funded by SkinMedica, Inc. | 166, 17 (1,3 & 1,3) | 85, 46 |
| (Eichenfield and Miller 2006) | RCT USA, MC, double blind, phase III study | Fluticasone propionate 0.05% lotion (V) | Lotion vehicle | QD | 28 | 438, not reported (221,217) | 3–192 (not reported), 6% ≤1 year | Moderate/Sever e, Not reported | Funded by GlaxoSmithKline. | 156, 64 (1,2 & 2) | 77, 82 |
Application site reactions= dermatitis, pruritus, irritation, burning
*
Numbers reported in article add up to great than 100%
#
moderate/severe prior to starting the stabilization phase, likely mild by the time randomized
$
Primary Outcomes Assessed: 1. Study-designated “good response”; 2. The number of participants with at least a 50% reduction in AD severity; 3. Eczema rated as cleared or controlled. Most studies did not report all three of these potential outcomes.