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Table 2 Study designs for long-term (≥12 weeks) tacrolimus 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 Use N Treatmentb
Controlled studies
 Paller 2001 [49] 12 moderate to severe (≥4.5 R&L) 6 yr (2–15) None 118 tacrolimus 0.1 % BID (DB) for flares
  117 tacrolimus 0.03 % BID (DB) for flares
  116 vehicle BID (DB) for flares
 Hofman 2006 [50] 28 moderate to severe (≥4.5 R&L) ~6 yr (2–11) None 133 tacrolimus 0.03 % BID for 3 wk, then tacrolimus QD + vehicle QD (DB) for flares
     - 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
  None 50 no treatment (patients did not have AD)
 Paller 2008 [51]
 Breneman 2008 [52]
42 moderate to severe (mean EASI = ~11) 7 yr (2–15) None 68 tacrolimus 0.03 % or alclometasone ointment 0.05 % BID for 4 d (DB), then BID (OL) for 2–16 wk until clearance; then tacrolimus 0.03 % QD 3x/wk (DB) and tacrolimus BID for flares
36 tacrolimus 0.03 % or alclometasone ointment 0.05 % BID for 4 d (DB), then BID (OL) for 2–16 wk until clearance; then vehicle QD 3x/wk (DB) and tacrolimus 0.03 % BID for flares
 Thaçi 2008 [53]
 Thaçi 2010 [54]
52 mild to severe (≥3 R&L) 7 yr (2–15) None 125 tacrolimus 0.03 % BID (OL) for 1–6 wk until clearance, then tacrolimus 0.3 % 2x/wk (DB) and tacrolimus 0.03 % BID (OL) for flares
125 tacrolimus 0.03 % BID (OL) for 1–6 wk until clearance, then vehicle 2x/wk (DB) and tacrolimus 0.03 % BID (OL) for flares
Uncontrolled studies  
 Kubota 2009 [55] 12 moderate to severe (mean EASI = 13) 7 yr (2–15) Nonec 31 OL tacrolimus 0.03 % QD + TCS (strong or weak) QD for 2 wk, then tacrolimus BID on weekdays and tacrolimus QD + TCS QD on weekends for 2 wk, then tacrolimus BID (no TCS) for 2 wk followed by tacrolimus BID (no TCS) for flares
 Tan 2004 [56] 24 mild to severe 8 yr (2–15) None 82 OL tacrolimus 0.1 % BID until 1wk after clearance, then tacrolimus 0.1 % BID for flares
 Kang 2001 [57] 52 moderate to severe (≥4.5 R&L) 8 yr (2–15) None 255 OL tacrolimus 0.1 % BID for flares
 Mandelin 2012 [58] 104 moderate to severe (mean EASI = 11) 15 mo (3–24) NRd 50 OL tacrolimus 0.03 % BID for 3 wk and then QD until clearance; thereafter BID for flares
 Hanifin 2005 [59] 156 (≤196 wk exposure) mild to severe (R&L) (2–15 yr) NRe 391 OL tacrolimus 0.1 % BID for flares for 3 yr (after 1 yr tacrolimus in unpublished lead-in study)
  1. N = safety population
  2. BID indicates twice daily, d days, DB double-blind, EASI eczema area and severity index, mo months, NR not reported, OL open label, PSGA physicians static global assessment, pts patients, QD once daily, R&L Rajka and Langeland, 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. cTCS use per protocol was permitted during the first 4 weeks and prohibited for the remainder of the study
  6. dTCS use was permitted (for up to 2 weeks in any 3 months) to treat flares not controlled by study medication; information on the incidence and duration of TCS use was NR
  7. eTCS use was not permitted, however an unspecfied number of patients deviated from protocol and used TCS; these patients were not excluded from study summary