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Vol. 64, No. 4, 2007
Issue release date: November 2007
Gynecol Obstet Invest 2007;64:180–186
(DOI:10.1159/000106487)

Pimecrolimus Cream 1% for Treatment of Vulvar Lichen Simplex Chronicus: An Open-Label, Preliminary Trial

Goldstein A.T. · Parneix-Spake A. · McCormick C.L. · Burrows L.J.
aDivision of Gynecologic Specialties, Department of Gynecology and Obstetrics, Johns Hopkins Medicine, Baltimore, Md., and bNovartis Pharmaceuticals Corp., East Hanover, N.J., USA

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Abstract

Background: To evaluate efficacy and safety of pimecrolimus cream 1% twice daily for treatment of vulvar lichen simplex chronicus (LSC). Methods: Patients in this 12-week, open-label study had biopsy-proven vulvar LSC. Inclusion criteria were patient-reported Visual Analog Scale for Pruritus Relief ≧3 (VAS-PR, 0 cm = no itching to 10 cm = severe itching) and Investigator’s Global Assessment ≧2 (IGA, 0 = no disease to 3 = severe disease). Safety was evaluated by adverse event reports and pimecrolimus blood level measurements. Results: Twelve women aged 25–53 years were enrolled. The median pruritus score (VAS-PR) decreased from 6 (min. 4.9, max. 9.0) at baseline to 0 cm at week 4 (max. 4.2), week 8 (max. 3.1) and week 12 (max. 2.1). Seven patients reported complete resolution of pruritus by week 4. Median IGA decreased from 2.5 (min. 2, max. 3) at baseline to 0 (min. 0, max. 2) at week 12. Erythema, excoriation, and lichenification improved for all patients. Pimecrolimus blood concentration for all samples was below the limit of quantification, 0.3 ng/ml. No adverse events were reported. Conclusions: In this exploratory study, signs and symptoms of vulvar LSC improved for all women and pimecrolimus cream showed a favorable safety profile. Larger prospective studies are needed to further evaluate pimecrolimus for treatment of vulvar LSC.



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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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    External Resources

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