Abstract | BACKGROUND: Data on the efficacy of pimecrolimus cream 1% within the first days of treatment are scarce, as in previous studies, the first postbaseline assessment was performed only after 1 week. OBJECTIVE: METHODS: We used pimecrolimus cream 1% (n = 129) or vehicle cream (n = 66) administered in a double-blind manner for 4 weeks and then open-label pimecrolimus cream 1% for 12 weeks, with a 4-week follow-up period. RESULTS:
Pimecrolimus cream 1% reduced the mean Eczema Area and Severity Index at 4 weeks by 71.5% compared with an increase of 19.4% with vehicle ( P < .001). The reduction in the Eczema Area and Severity Index with pimecrolimus cream 1% was significant at day 4 (38.5% vs 17.6% increase with vehicle). Significant improvements in caregivers' assessments of pruritus and sleep loss were observed with pimecrolimus cream 1% by day 2 ( P < .03) and day 3 ( P = .002), respectively, compared with vehicle. Responses to pimecrolimus cream 1% were sustained during the open-label phase, and pimecrolimus cream 1% was well tolerated. Symptoms of atopic eczema returned gradually after discontinuation. CONCLUSION:
Pimecrolimus cream 1% was well tolerated and effective in patients with mild to very severe atopic eczema, with rapid onset of action and no disease rebound after discontinuation.
|
Authors | Roland Kaufmann, Regina Fölster-Holst, Peter Höger, Diamant Thaçi, Helena Löffler, Doris Staab, Matthias Bräutigam, CASM981CDE04-Study Group |
Journal | The Journal of allergy and clinical immunology
(J Allergy Clin Immunol)
Vol. 114
Issue 5
Pg. 1183-8
(Nov 2004)
ISSN: 0091-6749 [Print] United States |
PMID | 15536429
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Ointments
- pimecrolimus
- Tacrolimus
|
Topics |
- Dermatitis, Atopic
(drug therapy)
- Double-Blind Method
- Female
- Follow-Up Studies
- Humans
- Infant
- Male
- Ointments
- Tacrolimus
(administration & dosage, adverse effects, analogs & derivatives)
|