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Table 4 Study designs for long-term (≥12 weeks) topical corticosteroid trials in pediatric patients (<12 years) with AD

From: Systematic review of published trials: long-term safety of topical corticosteroids and topical calcineurin inhibitors in pediatric patients with atopic dermatitis

Trial Duration (wk)a Baseline AD severity Age, mean (range) TCS Potency [87] N Treatmentb
Controlled studies
 Thomas 2002 [70] 18 mild to moderate (mean SASSAD = ~8–14) 5 yr (1–15) low (class 7–6) 104 hydrocortisone ointment 1 % BID (DB) for 7 d bursts “when required”
mild to moderate (mean SASSAD = ~9–16) 6 yr (1–15) mid (class 5–3) 103 alternating (DB) betamethasone valerate ointment 0.1 % BID (3 d) and emollient BID (4 d) for 7 d bursts “when required”
 Jorizzo 1995 [71] 25 mild to moderate 5 yr (<1–12) low (class 7–6) 16 desonide ointment 0.05 % BID (SB)
low (class 7–6) 20 hydrocortisone ointment 1 % BID (SB)
 Hanifin 2002 [72] 44 moderate to severe (mean R&L = 7) 7 yr (<1–17) mid (class 5–3) 154 fluticasone propionate cream 0.05 % BID (OL) for ≤4 wks until clearance; then fluticasone propionate BID (DB) decreased over 20 wk to QD 2x/wk; then fluticasone propionate QD 2x/wk (OL) for 20 wk
- 77 fluticasone propionate cream 0.05 % BID (OL) for ≤4 wks until clearance; then vehicle BID (DB) decreased over 20 wk to QD 2x/wk; then fluticasone propionate QD 2x/wk (OL) for 20 wk
Meta-analysis  
 Kirkup 2003 [73]c 16 moderate to severe (mean ADd = ~12e) 8 yr (2–14) mid (class 5–3) 136 hydrocortisone 1 % cream BID for 1–2 wk, then fluticasone propionate cream 0.05 % BID (DB) for 2–4 wk and then “as required” for flares
low or mid (class 7–3) 129 hydrocortisone 1 % cream BID for 1–2 wk, then hydrocortisone 1 % or hydrocortisone butyrate 0.1 % BID (DB) for 2–4 wk and then “as required” for flares
TCS as active comparatorf
 Hofman 2006 [50] 28 moderate to severe (≥4.5 R&L) ~6 yr (2–11) - 133 tacrolimus 0.03 % BID for 3 wk, then tacrolimus QD + vehicle QD (DB) for flares
low (class 7–6) 124 hydrocortisone ointment 1 % BID for head/neck and hydrocortisone butyrate ointment 0.1 % BID for trunk/limbs for 2 wk, then hydrocortisone 1 % BID (DB) for flares
     - 50 no treatment (patients did not have AD)
 Sigurgeirsson 2015 [61] 260 mild to moderate (IGA = 2–3) 7 mo (3–12) - 1205 pimecrolimus 1 % (OL) until clearance, and then as needed for flaresg
mild to moderate (IGA = 2–3) 7 mo (3–12) low or mid (class 7–3) 1213 hydrocortisone 1 % or hydrocortisone butyrate 0.1 %(OL) until clearance, and then as needed for flaresg
  1. N = safety population
  2. AD indicates atopic dermatitis, BID twice daily, d days, DB double-blind, EASI eczema area and severity index, IGA investigator’s global assessment, mo months, NR not reported, OL open label, pts patients, QD once daily, R&L Rajka and Langeland, SASSAD Six area, six sign atopic dermatitis, TCS topical corticosteroids, wk week(s), yr year(s)
  3. aFor trials of <12 months: duration in weeks = 4 X total months of study. For trials ≥1 year: duration in weeks = 52 X total years of study
  4. bTo differentiate the long-term study treatments from any short-term lead-in treatments, the long-term treatments are indicated in bold
  5. cMeta-analysis of 2 previously unpublished studies
  6. dAD Score (max 21) = Number of body areas affected (max 12) + Sum of erythema, excoriation, and lichenification scores (each graded 0–3) at target area (max 9)
  7. eAfter ‘run in’
  8. fTCS treatment was an active comparator arm in 2 TCI trials: Hofman et al. 2006 (also listed in Table 1) and Sigurgeirsson (also listed in Table 2)
  9. gPimecrolimus and TCS dosing during acute and maintenance phases was per the study country’s label