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.
Goldstein
Andrew T
AT
Division of Gynecologic Specialties, Department of Gynecology and Obstetrics, Johns Hopkins Medicine, Baltimore, MD, USA. obstetrics@yahoo.com
Parneix-Spake
Anne
A
McCormick
Calogera L
CL
Burrows
Lara J
LJ
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