Pimecrolimus cream 1% in the treatment of lichen sclerosus

Gynecol Obstet Invest. 2007;63(3):151-4. doi: 10.1159/000096736. Epub 2006 Nov 2.

Abstract

Background: Lichen sclerosus (LS) is a chronic inflammatory skin condition, which most commonly causes dysuria, pruritus and soreness of the vulval and perianal areas. Potent topical corticosteroids are used for the treatment of LS, but it is well known that they inhibit collagen synthesis and cause skin atrophy as a side effect.

Methods: The present pilot study evaluated the efficacy and safety of pimecrolimus cream 1% applied twice daily for up to 6 months in 29 women with severe LS.

Results: Of the 26 subjects who completed the follow-up period, 42% (11/26) were in complete remission with relief from itchiness, pain and inflammation. A 3.5-fold increase in type I collagen synthesis and a 7.5-fold increase in type III collagen synthesis of the affected areas was detected after 2 months of pimecrolimus treatment. There were no systemic adverse reactions, although mild local skin reactions were reported by 50% of the patients. Blood concentrations of pimecrolimus were checked in 10/26 patients (39%) and were undetectable in all cases.

Conclusions: Patient-applied 1% pimecrolimus cream is safe and effective for the treatment of LS.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Dermatologic Agents / adverse effects
  • Dermatologic Agents / therapeutic use*
  • Female
  • Humans
  • Lichen Sclerosus et Atrophicus / drug therapy*
  • Lichen Sclerosus et Atrophicus / pathology*
  • Middle Aged
  • Ointments
  • Pilot Projects
  • Remission Induction
  • Safety
  • Tacrolimus / adverse effects
  • Tacrolimus / analogs & derivatives*
  • Tacrolimus / therapeutic use
  • Time Factors
  • Treatment Outcome

Substances

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