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Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone acetate ointment in children with atopic dermatitis.

AbstractBACKGROUND:
Vehicle-controlled studies have demonstrated the efficacy and safety of tacrolimus ointment in the treatment of patients with atopic dermatitis (AD).
OBJECTIVE:
This study was undertaken to compare 0.03% and 0.1% tacrolimus ointment with 1% hydrocortisone acetate ointment in children 2 to 15 years of age with moderate-to-severe AD.
METHODS:
Treatment was twice daily to affected areas for 3 weeks in this multicenter, randomized, double-blind, parallel-group study. The primary endpoint was the modified eczema area and severity index (mEASI) mean area under the curve (mAUC) as a percentage of baseline.
RESULTS:
Five hundred sixty patients were randomized and received at least one application of ointment. Discontinuations included 21 of 189 patients from the 0.03% tacrolimus group, 13 of 186 patients from the 0.1% tacrolimus group, and 20 of 185 patients from the hydrocortisone acetate group. The median mEASI mAUC as a percentage of baseline showed 0.03% and 0.1% tacrolimus to be significantly more effective than 1% hydrocortisone acetate (P <.001) and 0.1% tacrolimus to be more effective than 0.03% tacrolimus (P =.006). The mEASI mAUC as a percentage of baseline was 44.8%, 39.8%, and 64.0% for patients who received 0.03% tacrolimus, 0.1% tacrolimus, and 1% hydrocortisone acetate, respectively. Transient skin burning was the only adverse event to show a higher incidence in the tacrolimus treatment groups than in the hydrocortisone acetate group (P <.05). Laboratory parameters showed no treatment differences and no marked changes over time.
CONCLUSION:
Tacrolimus, 0.03% and 0.1%, was significantly more effective than 1% hydrocortisone acetate and 0.1% tacrolimus was more effective than 0.03% tacrolimus in the treatment of moderate-to-severe AD in children. No safety concerns were identified.
AuthorsSakari Reitamo, Edwin J M Van Leent, Vincent Ho, John Harper, Thomas Ruzicka, Kirsti Kalimo, Frédéric Cambazard, Malcolm Rustin, Alain Taïeb, David Gratton, Daniel Sauder, Graham Sharpe, Catherine Smith, Michael Jünger, Yves de Prost, European /Canadian Tacrolimus Ointment Study Group
JournalThe Journal of allergy and clinical immunology (J Allergy Clin Immunol) Vol. 109 Issue 3 Pg. 539-46 (Mar 2002) ISSN: 0091-6749 [Print] United States
PMID11898004 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Immunosuppressive Agents
  • hydrocortisone acetate
  • Hydrocortisone
  • Tacrolimus
Topics
  • Administration, Topical
  • Adolescent
  • Child
  • Child, Preschool
  • Dermatitis, Atopic (drug therapy)
  • Double-Blind Method
  • Female
  • Humans
  • Hydrocortisone (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
  • Immunosuppressive Agents (administration & dosage, adverse effects, therapeutic use)
  • Male
  • Tacrolimus (administration & dosage, adverse effects, therapeutic use)
  • Treatment Outcome

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