0.03% Tacrolimus ointment applied once or twice daily is more efficacious than 1% hydrocortisone acetate in children with moderate to severe atopic dermatitis

Results of a randomized double-blind controlled trial

S. Reitamo, J. Harper, J. Dbos, F. Cambazard, C. Bruijnzeel-Koomen, P. Valk, C. Smith, C. Moss, A. Dobozy, R. Palatsi

Research output: Contribution to journalArticle

99 Citations (Scopus)

Abstract

Background: Topical corticosteroids are the usual treatment for atopic dermatitis (AD) in children but can have side-effects. Objectives: This study compared the efficacy and safety of 0.03% tacrolimus ointment applied once or twice daily over a 3-week period with the twice daily application of 1% hydrocortisone acetate (HA) ointment in children with moderate to severe AD. Patients and methods: Patients applied ointment daily to all affected body surface areas. The primary study endpoint was the percentage change in the modified Eczema Area and Severity Index (mEASI) between baseline and treatment end. Results: Six hundred and twenty-four patients, aged 2-15 years, applied 0.03% tacrolimus ointment once daily (n = 207), twice daily (n = 210) or 1% HA twice daily (n = 207). By the end of treatment, application of 0.03% tacrolimus ointment both once or twice daily resulted in significantly greater median percentage decreases in mEASI (66.7% and 76.7%, respectively) compared with 1% HA (47.6%; P <0.001). Furthermore, the median percentage decrease in mEASI was significantly greater for patients applying 0.03% tacrolimus twice daily compared with once daily (P = 0.007). Patients with severe AD benefited especially from twice daily application of 0.03% tacrolimus ointment compared with once daily application (P = 0.001). Transient mild to moderate skin burning occurred significantly more often in the 0.03% tacrolimus groups (P = 0.028) but resolved in most cases within 3-4 days. Laboratory parameters showed no clinically relevant changes. Conclusions 0.03% tacrolimus ointment applied once or twice daily is significantly more efficacious than 1% HA in treating moderate-severe AD in children. Twice daily application of 0.03% tacrolimus ointment results in the greatest improvement in mEASI, and is especially effective in patients with severe baseline disease.

Original languageEnglish
Pages (from-to)554-562
Number of pages9
JournalBritish Journal of Dermatology
Volume150
Issue number3
DOIs
Publication statusPublished - Mar 2004

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hydrocortisone acetate
Tacrolimus
Atopic Dermatitis
Ointments
Eczema
Body Surface Area

Keywords

  • Atopic dermatitis
  • Efficacy
  • Paediatric
  • Tacrolimus ointment 0.03%

ASJC Scopus subject areas

  • Dermatology

Cite this

0.03% Tacrolimus ointment applied once or twice daily is more efficacious than 1% hydrocortisone acetate in children with moderate to severe atopic dermatitis : Results of a randomized double-blind controlled trial. / Reitamo, S.; Harper, J.; Dbos, J.; Cambazard, F.; Bruijnzeel-Koomen, C.; Valk, P.; Smith, C.; Moss, C.; Dobozy, A.; Palatsi, R.

In: British Journal of Dermatology, Vol. 150, No. 3, 03.2004, p. 554-562.

Research output: Contribution to journalArticle

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abstract = "Background: Topical corticosteroids are the usual treatment for atopic dermatitis (AD) in children but can have side-effects. Objectives: This study compared the efficacy and safety of 0.03{\%} tacrolimus ointment applied once or twice daily over a 3-week period with the twice daily application of 1{\%} hydrocortisone acetate (HA) ointment in children with moderate to severe AD. Patients and methods: Patients applied ointment daily to all affected body surface areas. The primary study endpoint was the percentage change in the modified Eczema Area and Severity Index (mEASI) between baseline and treatment end. Results: Six hundred and twenty-four patients, aged 2-15 years, applied 0.03{\%} tacrolimus ointment once daily (n = 207), twice daily (n = 210) or 1{\%} HA twice daily (n = 207). By the end of treatment, application of 0.03{\%} tacrolimus ointment both once or twice daily resulted in significantly greater median percentage decreases in mEASI (66.7{\%} and 76.7{\%}, respectively) compared with 1{\%} HA (47.6{\%}; P <0.001). Furthermore, the median percentage decrease in mEASI was significantly greater for patients applying 0.03{\%} tacrolimus twice daily compared with once daily (P = 0.007). Patients with severe AD benefited especially from twice daily application of 0.03{\%} tacrolimus ointment compared with once daily application (P = 0.001). Transient mild to moderate skin burning occurred significantly more often in the 0.03{\%} tacrolimus groups (P = 0.028) but resolved in most cases within 3-4 days. Laboratory parameters showed no clinically relevant changes. Conclusions 0.03{\%} tacrolimus ointment applied once or twice daily is significantly more efficacious than 1{\%} HA in treating moderate-severe AD in children. Twice daily application of 0.03{\%} tacrolimus ointment results in the greatest improvement in mEASI, and is especially effective in patients with severe baseline disease.",
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T1 - 0.03% Tacrolimus ointment applied once or twice daily is more efficacious than 1% hydrocortisone acetate in children with moderate to severe atopic dermatitis

T2 - Results of a randomized double-blind controlled trial

AU - Reitamo, S.

AU - Harper, J.

AU - Dbos, J.

AU - Cambazard, F.

AU - Bruijnzeel-Koomen, C.

AU - Valk, P.

AU - Smith, C.

AU - Moss, C.

AU - Dobozy, A.

AU - Palatsi, R.

PY - 2004/3

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N2 - Background: Topical corticosteroids are the usual treatment for atopic dermatitis (AD) in children but can have side-effects. Objectives: This study compared the efficacy and safety of 0.03% tacrolimus ointment applied once or twice daily over a 3-week period with the twice daily application of 1% hydrocortisone acetate (HA) ointment in children with moderate to severe AD. Patients and methods: Patients applied ointment daily to all affected body surface areas. The primary study endpoint was the percentage change in the modified Eczema Area and Severity Index (mEASI) between baseline and treatment end. Results: Six hundred and twenty-four patients, aged 2-15 years, applied 0.03% tacrolimus ointment once daily (n = 207), twice daily (n = 210) or 1% HA twice daily (n = 207). By the end of treatment, application of 0.03% tacrolimus ointment both once or twice daily resulted in significantly greater median percentage decreases in mEASI (66.7% and 76.7%, respectively) compared with 1% HA (47.6%; P <0.001). Furthermore, the median percentage decrease in mEASI was significantly greater for patients applying 0.03% tacrolimus twice daily compared with once daily (P = 0.007). Patients with severe AD benefited especially from twice daily application of 0.03% tacrolimus ointment compared with once daily application (P = 0.001). Transient mild to moderate skin burning occurred significantly more often in the 0.03% tacrolimus groups (P = 0.028) but resolved in most cases within 3-4 days. Laboratory parameters showed no clinically relevant changes. Conclusions 0.03% tacrolimus ointment applied once or twice daily is significantly more efficacious than 1% HA in treating moderate-severe AD in children. Twice daily application of 0.03% tacrolimus ointment results in the greatest improvement in mEASI, and is especially effective in patients with severe baseline disease.

AB - Background: Topical corticosteroids are the usual treatment for atopic dermatitis (AD) in children but can have side-effects. Objectives: This study compared the efficacy and safety of 0.03% tacrolimus ointment applied once or twice daily over a 3-week period with the twice daily application of 1% hydrocortisone acetate (HA) ointment in children with moderate to severe AD. Patients and methods: Patients applied ointment daily to all affected body surface areas. The primary study endpoint was the percentage change in the modified Eczema Area and Severity Index (mEASI) between baseline and treatment end. Results: Six hundred and twenty-four patients, aged 2-15 years, applied 0.03% tacrolimus ointment once daily (n = 207), twice daily (n = 210) or 1% HA twice daily (n = 207). By the end of treatment, application of 0.03% tacrolimus ointment both once or twice daily resulted in significantly greater median percentage decreases in mEASI (66.7% and 76.7%, respectively) compared with 1% HA (47.6%; P <0.001). Furthermore, the median percentage decrease in mEASI was significantly greater for patients applying 0.03% tacrolimus twice daily compared with once daily (P = 0.007). Patients with severe AD benefited especially from twice daily application of 0.03% tacrolimus ointment compared with once daily application (P = 0.001). Transient mild to moderate skin burning occurred significantly more often in the 0.03% tacrolimus groups (P = 0.028) but resolved in most cases within 3-4 days. Laboratory parameters showed no clinically relevant changes. Conclusions 0.03% tacrolimus ointment applied once or twice daily is significantly more efficacious than 1% HA in treating moderate-severe AD in children. Twice daily application of 0.03% tacrolimus ointment results in the greatest improvement in mEASI, and is especially effective in patients with severe baseline disease.

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KW - Efficacy

KW - Paediatric

KW - Tacrolimus ointment 0.03%

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