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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.
Br J Dermatol. 2004 Mar; 150(3):554-62.BJ

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.

Authors+Show Affiliations

Department of Dermatology, Helsinki University Central Hospital, Helsinki, Finland. sakari.reitamo@hus.fiNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15030341

Citation

Reitamo, S, 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." The British Journal of Dermatology, vol. 150, no. 3, 2004, pp. 554-62.
Reitamo S, Harper J, Bos JD, 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. Br J Dermatol. 2004;150(3):554-62.
Reitamo, S., Harper, J., Bos, J. D., Cambazard, F., Bruijnzeel-Koomen, C., Valk, P., Smith, C., Moss, C., Dobozy, A., & 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. The British Journal of Dermatology, 150(3), 554-62.
Reitamo S, 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. Br J Dermatol. 2004;150(3):554-62. PubMed PMID: 15030341.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR 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: results of a randomized double-blind controlled trial. AU - Reitamo,S, AU - Harper,J, AU - Bos,J D, AU - Cambazard,F, AU - Bruijnzeel-Koomen,C, AU - Valk,P, AU - Smith,C, AU - Moss,C, AU - Dobozy,A, AU - Palatsi,R, AU - ,, PY - 2004/3/20/pubmed PY - 2004/5/5/medline PY - 2004/3/20/entrez SP - 554 EP - 62 JF - The British journal of dermatology JO - Br. J. Dermatol. VL - 150 IS - 3 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. SN - 0007-0963 UR - https://www.unboundmedicine.com/medline/citation/15030341/0_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_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&amp;sid=nlm:pubmed&amp;issn=0007-0963&amp;date=2004&amp;volume=150&amp;issue=3&amp;spage=554 DB - PRIME DP - Unbound Medicine ER -