Table 1.
Characteristics of randomised controlled trials included in meta-analysis
| Trial | No (age) of participants | Severity of atopic dermatitis | Intervention; control | Quality score8 | Duration and blinding | Outcomes |
|---|---|---|---|---|---|---|
| Barba 200318 | 114 infants, children, and young people (3 months to 18 years) | Mild to moderate facial eczema | Pimecrolimus 1% twice daily; vehicle | 3/5 | Three weeks DB followed by 24 weeks open label | IGA, pruritus, patient assessment |
| Eichenfield 200212 | 198 children and young people (2-16 years) | Mild to moderate | Pimecrolimus 1% twice daily; vehicle | 3/5 | Six weeks DB followed by 20 weeks open label | IGA, EASI, pruritus, individual symptoms (erythema, induration or papulation, excoriation, lichenification) |
| Eichenfield 200212 | 205 children and young people (2-16 years) | Mild to moderate | Pimecrolimus 1% twice daily; vehicle | 3/5 | Six weeks DB followed by 20 weeks open label | IGA, EASI, pruritus, individual symptoms (erythema, induration or papulation, excoriation, lichenification) |
| Ho 200313 | 186 infants (2-23 months) | Mild to moderate | Pimecrolimus 1% twice daily; vehicle | 3/5 | Six weeks DB followed by 20 weeks open label | IGA, EASI, pruritus, individual symptoms (erythema, induration or papulation, excoriation, lichenification) |
| Kapp 200214 | 251 infants (3-23 months) | Mild to severe | Pimecrolimus 1% twice daily; vehicle | 4/5 | 12 months DB | Incidence of flares, IGA, topical corticosteroid requirement, pruritus, caregiver assessment, EASI |
| Kempers 200331 | 141 children (2-17 years) | Moderate | Pimecrolimus 1% twice daily; tacrolimus 0.03% twice daily | 3/5 | Six weeks DB followed by 20 weeks open label | IGA, pruritus, formulation acceptability |
| Ling 200219 | 49 adults and children (>10 years) | Moderate to severe | Pimecrolimus 1% four times daily; pimecrolimus 1% twice daily | 2/5 | Three weeks DB with crossover after seven days | IGA, EASI, pruritus, body surface area affected |
| Luger 200115 | 130 adults | Moderate to severe | Pimecrolimus 0.05%, 0.2%, 0.6%, and 1% twice daily; vehicle or betamethasone-17-valerate 0.1% | 3/5 | Three weeks DB | EASI, IGA, pruritus |
| Luger 200433 | 658 adults | Moderate to severe | Pimecrolimus 1% twice daily; triamcinolone acetonide 0.1% (trunk, limbs) hydrocortisone acetate 1% (face, neck, intertriginous areas) | 3/5 | 12 months DB | EASI, IGA, skin infections, reaction at application site |
| Meurer 200216 | 192 adults | Moderate to severe | Pimecrolimus 1% twice daily; vehicle | 5/5 | Six months DB | Topical corticosteroid requirement, incidence of flares, IGA, EASI, QoL score (DLQI and QoLIAD), pruritus |
| Wahn 200217 | 713 children and young people (2-17 years) | Mild to severe | Pimecrolimus 1% twice daily; vehicle | 5/5 | 12 months DB | Incidence of flares, IGA, topical corticosteroid requirement |
| Boguniewicz 199820 | 136 children and young people (7-16 years) | Moderate to severe | Tacrolimus 0.03%, 0.1%, and 0.3% twice daily; vehicle | 5/5 | Three weeks DB | PGE, pruritus |
| Hanifin 199830 | 33 children (3-6 years) | Moderate to severe | Tacrolimus 0.03% and 0.1% twice daily; vehicle | 2/5 | Three weeks DB | PGE (marked improvement or better) |
| Hanifin 200121 | 205 adults | Moderate to severe | Tacrolimus 0.03% and 0.1% twice daily; vehicle | 3/5 | 12 weeks DB | PGE, EASI, pruritus, individual symptoms (oedema, erythema, excoriation, lichenification, oozing, scaling) |
| Hanifin 200121 | 218 adults | Moderate to severe | Tacrolimus 0.03% and 0.1% twice daily; vehicle | 3/5 | 12 weeks DB | PGE, EASI, pruritus, individual symptoms (oedema, erythema, excoriation, lichenification, oozing, scaling) |
| Kang 199829 | 26 adults | Moderate to severe | Tacrolimus 0.03%, 0.1%, and 0.3% twice daily; vehicle | 2/5 | Three weeks DB | PGE (marked improvement or better) |
| Kawashima 199727 | 181 adults | Moderate to severe | Tacrolimus 0.1% twice daily; betamethasone valerate 0.12% | 5/5 | Three weeks DB | PGE, individual symptoms (erythema, swelling, papules, prurigo nodularis, infiltration, desquamation, erosion, encrustation, itching) |
| Nakagawa 199828 | 143 adults | Moderate to severe | Tacrolimus 0.1% twice daily; aclometasone dipropionate 0.1% | 1/5 | One week DB | PGE (face and neck) |
| Pacor 200434 | 30 children and adults (13-45 years) | Moderate to severe | Tacrolimus 0.1% twice daily; oral cyclosporin 3 mg/kg once daily | 5/5 | Six weeks DB | SCORAD, pruritus, erythema, adverse events |
| Paller 200122 | 351 children (2-15 years) | Moderate to severe | Tacrolimus 0.03% and 0.1% twice daily; vehicle | 3/5 | 12 weeks DB | PGE, EASI, pruritus, individual symptoms (oedema, erythema, excoriation, lichenification, oozing, scaling) |
| Reitamo 200223 | 570 adults | Moderate to severe | Tacrolimus 0.03% and 0.1% twice daily; hydrocortisone butyrate 0.1% | 5/5 | Three weeks DB | mEASI, PGE |
| Reitamo 200224 | 560 children | Moderate to severe | Tacrolimus 0.03% and 0.1% twice daily; hydrocortisone acetate 1% | 5/5 | Three weeks DB | mEASI, PGE |
| Reitamo 200332 | 968 adults | Moderate to severe | Tacrolimus 0.1% twice daily; hydrocortisone butyrate 0.1% (trunk, extremities) hydrocortisone acetate 1% (head, neck) | 5/5 | 24 weeks DB | mEASI, PGE |
| Reitamo 200426 | 623 children | Moderate to severe | Tacrolimus 0.03% twice daily and once daily; hydrocortisone acetate 1% | 4/5 | Three weeks DB | mEASI, PGE, itch, quality of sleep |
| Ruzicka 199725 | 162 adults | Moderate to severe | Tacrolimus 0.03%, 0.1%, and 0.3% twice daily; vehicle | 4/5 | Three weeks DB | PGE |
DB=double blind; DLQI=dermatology life quality index; EASI=eczema area and severity index (mEASI=modified EASI); IGA=investigators' global assessment; PGE=physicians' global evaluation; QoL=quality of life; QoLIAD=quality of life index—atopic dermatitis; SCORAD=severity scoring of atopic dermatitis index.