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

Sakari Reitamo; J. Harper; J.D. Bos; F. Cambazard; C. Bruijnzeel-Koomen; P. Valk; C. Smith; C. Moss; A. Dobozy; R. Palatsi

eISSN: 2299-0046
ISSN: 1642-395X

Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii

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4/2004
vol. 21

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abstract:

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

Sakari Reitamo

,

J. Harper

,

J.D. Bos

,

F. Cambazard

,

C. Bruijnzeel-Koomen

,

P. Valk

,

C. Smith

,

C. Moss

,

A. Dobozy

,

R. Palatsi

PDiA 2004; XXI, 4: 167–176

Online publish date: 2004/08/26

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AMA

Reitamo S, Harper J, Bos J, et al. 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. Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii. 2004;21(4):167-176.

APA

Reitamo, S., Harper, J., Bos, J., Cambazard, F., Bruijnzeel-Koomen, C.,  & Valk, P. et al. (2004). 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. Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii, 21(4), 167-176.

Chicago

Reitamo, Sakari, J. Harper, J.D. Bos, F. Cambazard, C. Bruijnzeel-Koomen, P. Valk,  and C. Smith et al. 2004. "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". Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii 21 (4): 167-176.

Harvard

Reitamo, S., Harper, J., Bos, J., Cambazard, F., Bruijnzeel-Koomen, C., Valk, P., Smith, C., Moss, C., Dobozy, A.,  and Palatsi, R. (2004). 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. Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii, 21(4), pp.167-176.

MLA

Reitamo, Sakari et al. "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." Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii, vol. 21, no. 4, 2004, pp. 167-176.

Vancouver

Reitamo S, Harper J, Bos J, Cambazard F, Bruijnzeel-Koomen C, Valk P et al. 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. Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii. 2004;21(4):167-176.

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.

keywords:

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

Sakari Reitamo , J. Harper , J.D. Bos , F. Cambazard , C. Bruijnzeel-Koomen , P. Valk , C. Smith , C. Moss , A. Dobozy , R. Palatsi

atopic dermatitis, efficacy, paediatric, tacrolimus ointment 003%

Sakari Reitamo

,

J. Harper

,

J.D. Bos

,

F. Cambazard

,

C. Bruijnzeel-Koomen

,

P. Valk

,

C. Smith

,

C. Moss

,

A. Dobozy

,

R. Palatsi