Pimecrolimus cream 1% for treatment of vulvar lichen simplex chronicus: an open-label, preliminary trial.

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 > 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.

• Authors: Andrew T Goldstein, Anne Parneix-Spake, Calogera L McCormick, Lara J Burrows
• Journal: Gynecologic and obstetric investigation (Gynecol Obstet Invest) Vol. 64 Issue 4 Pg. 180-6 ( 2007) ISSN: 1423-002X [Electronic] Switzerland
• PMID: 17664878 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: 2007 S. Karger AG, Basel

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• pimecrolimus
• Tacrolimus

Topics

• Administration, Cutaneous
• Adult
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, blood, therapeutic use)
• Female
• Humans
• Middle Aged
• Neurodermatitis (drug therapy, pathology)
• Severity of Illness Index
• Tacrolimus (administration & dosage, analogs & derivatives, blood, therapeutic use)
• Treatment Outcome
• Vulvar Diseases (drug therapy, pathology)