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 | Â | |||||
 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) |