Efficacy and safety of pimecrolimus cream 1% in adult patients with vitiligo: results of a randomized, double-blind, vehicle-controlled study
| Autor: | Maximilian Grassberger, Markus Dawid, Klaus Wolff, Marge Veensalu |
|---|---|
| Jazyk: | němčina |
| Rok vydání: | 2006 |
| Předmět: |
Target lesion
Adult Male medicine.medical_specialty Adolescent Administration Topical Vitiligo Dermatology Placebo Risk Assessment Tacrolimus law.invention Pimecrolimus Randomized controlled trial Double-Blind Method law Risk Factors Medicine Humans skin and connective tissue diseases Adverse effect Child Adult patients Dose-Response Relationship Drug business.industry Middle Aged medicine.disease Placebo Effect Surgery Treatment Outcome Female Dermatologic Agents Clobetasol propionate business medicine.drug |
| Zdroj: | Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG. 4(11) |
| ISSN: | 1610-0387 |
| Popis: | Summary Background: Vitiligo is an acquired, pigmentary skin disorder which is disfiguring and difficult to treat. In an earlier open label study in adult patients with vitiligo, pimecrolimus cream 1% was reported to have similar efficacy as clobetasol propionate 0.05%. We performed a double-blind, intrapatient comparison of pimecrolimus cream 1% with placebo cream. Patients and methods: Twenty adult Caucasians with symmetrical vitiligo (predominantly on extremities, none in the face) were treated b.i.d. for 6 months left/right with pimecrolimus/vehicle (N = 10) or vehicle/pimecrolimus (N = 10), respectively. Primary efficacy endpoint was the size of the target lesion at month 6 and secondary efficacy endpoint was re-pigmentation. Results: Treatment with pimecrolimus cream 1% or vehicle resulted in no significant change in mean target lesion size. Modest repigmentation (1–25%) was noted with pimecrolimus at month 2 in 12 of 17 patients (vehicle: 9 of 17 patients). Afterwards, the number of patients who experienced an improvement of pigmentation steadily decreased (3 of 14 patients with pimecrolimus and 2 of 14 with placebo at month 6).Treatment was well tolerated.There were no treatment-related adverse events, no induction of skin atrophy nor any other application site side effects. Conclusion: In this group of adult patients with symmetrical vitiligo, treatment of body lesions (except face) with pimecrolimus cream 1% could not be shown to be effective. |
| Databáze: | OpenAIRE |
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