Proactive maintenance therapy with a topical corticosteroid for vulvar lichen sclerosus: preliminary results of a randomized study

Br J Dermatol. 2013 Jun;168(6):1316-24. doi: 10.1111/bjd.12273.

Abstract

Background: The chronic and relapsing nature of vulvar lichen sclerosus (VLS) represents a challenge for its long-term management after an effective treatment with topical corticosteroids.

Objectives: To assess the effectiveness of proactive, twice-weekly application of mometasone furoate 0·1% ointment, compared with daily topical vitamin E or cold cream, in keeping VLS in remission and reducing the risk of relapse after 3 months of treatment with topical corticosteroid.

Methods: In total, 27 patients affected with VLS were enrolled into a 12-week active treatment phase (AP) with topical mometasone furoate 0·1% ointment once daily. Those who achieved disease remission entered a 52-week maintenance phase (MP) in which patients were randomized to apply either mometasone furoate 0·1% ointment twice weekly, a cold cream once daily or topical vitamin E once daily. The primary efficacy parameters were the relapse rate and the mean time to relapse.

Results: Twenty-five patients considered to have been completely or almost completely healed after the AP entered the MP. By the end of the 52-week MP, 10 patients (40%) experienced a relapse: five in the vitamin E group (56%) and five in the cold cream group (62%), while no patient in the mometasone furoate 0·1% ointment group had a relapse. The occurrence of VLS relapse for patients in therapy with both vitamin E and cold cream was significantly higher than for those in proactive therapy with topical corticosteroid. The median time to relapse was the same (21·6 weeks) for the vitamin E and the emollient groups.

Conclusions: Once VLS has been stabilized with topical corticosteroids, twice-weekly proactive application of mometasone furoate 0·1% ointment over 56 weeks was found to be an effective and safe therapy option in maintaining VLS remission and in preventing the occurrence of relapse.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Aged
  • Anti-Inflammatory Agents / administration & dosage*
  • Drug Administration Schedule
  • Emollients / administration & dosage*
  • Female
  • Glucocorticoids / administration & dosage*
  • Humans
  • Italy
  • Middle Aged
  • Mometasone Furoate
  • Pregnadienediols / administration & dosage*
  • Secondary Prevention
  • Time Factors
  • Treatment Outcome
  • Vitamin E / administration & dosage*
  • Vulvar Lichen Sclerosus / drug therapy*
  • Vulvar Lichen Sclerosus / prevention & control

Substances

  • Anti-Inflammatory Agents
  • Emollients
  • Glucocorticoids
  • Pregnadienediols
  • Mometasone Furoate
  • Vitamin E