Abstract | BACKGROUND: OBJECTIVE: 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:
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Authors | Sakari 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 |
Journal | The 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 |
PMID | 11898004
(Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Immunosuppressive Agents
- hydrocortisone acetate
- Hydrocortisone
- Tacrolimus
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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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