title: Proactive maintenance therapy with a topical corticosteroid for vulvar lichen sclerosus: preliminary results of a randomized study.
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.
  
  
  OBJECTIVE
  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.
authors: Department of Clinical and Experimental Medicine, Section of Dermatology, University of Ferrara, Via Savonarola 9, 44121, Ferrara, Italy. vri@unife.it
authors: A
authors: A
authors: Virgili
authors: S
authors: S
authors: Minghetti
authors: A
authors: A
authors: Borghi
authors: M
authors: M
authors: Corazza
mesh_terms: D000287:Administration, Topical; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004643:Emollients / Q000008:administration & dosage*; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007558:Italy; D008875:Middle Aged; D000068656:Mometasone Furoate; D011244:Pregnadienediols / Q000008:administration & dosage*; D055502:Secondary Prevention; D013997:Time Factors; D016896:Treatment Outcome; D014810:Vitamin E / Q000008:administration & dosage*; D007724:Vulvar Lichen Sclerosus / Q000188:drug therapy* / Q000517:prevention & control
chemical_list: D000893:Anti-Inflammatory Agents; D004643:Emollients; D005938:Glucocorticoids; D011244:Pregnadienediols; D000068656:Mometasone Furoate; D014810:Vitamin E