Pimecrolimus cream 1% for treatment of vulvar lichen simplex chronicus: an open-label, preliminary trial.
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 > or = 3 (VAS-PR, 0 cm = no itching to 10 cm = severe itching) and Investigator's Global Assessment > or = 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.
Division of Gynecologic Specialties, Department of Gynecology and Obstetrics, Johns Hopkins Medicine, Baltimore, MD, USA. obstetrics@yahoo.com
Andrew T
AT
Goldstein
Anne
A
Parneix-Spake
Calogera L
CL
McCormick
Lara J
LJ
Burrows
D000279:Administration, Cutaneous; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009450:Neurodermatitis / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood / Q000627:therapeutic use; D016896:Treatment Outcome; D014845:Vulvar Diseases / Q000188:drug therapy* / Q000473:pathology
D000894:Anti-Inflammatory Agents, Non-Steroidal; C117268:pimecrolimus; D016559:Tacrolimus