title: Long-term maintenance therapy for vulvar lichen sclerosus: the results of a randomized study comparing topical vitamin E with an emollient.
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 compare the effect of topical vitamin E with that of an emollient in reducing the risk of VLS relapse over a 52-week maintenance treatment.
  
  
  METHODS
  156 patients with VLS were enrolled in a 12-week active treatment phase on topical 0.1% mometasone furoate ointment once daily. Those who achieved disease remission entered a 52-week maintenance phase in which patients were randomized to apply either an emollient or topical vitamin E once daily.
  
  
  RESULTS
  80 patients entered the maintenance phase. At 52 weeks, for the vitamin E maintenance group, the cumulative crude relapse rate was 27.8% and the cumulative modified crude relapse rate was 55.6%. For the emollient maintenance group, the cumulative crude relapse rate was 22.7% and the cumulative modified crude relapse rate was 50.0%. The median time to relapse was 20 weeks for the vitamin E group and 18.7 weeks for the emollient group.
  
  
  CONCLUSIONS
  Once VLS has been stabilized with topical corticosteroids, long-term treatment with both vitamin E and emollients may be considered in maintain LS remission.
authors.affiliation: Department of Clinical and Experimental Medicine, Section of Dermatology, University of Ferrara, Via Savonarola 9, 44100 Ferrara, Italy. vri@unife.it
authors.forename: Annarosa
authors.initials: A
authors.lastname: Virgili
authors.forename: Sara
authors.initials: S
authors.lastname: Minghetti
authors.forename: Alessandro
authors.initials: A
authors.lastname: Borghi
authors.forename: Monica
authors.initials: M
authors.lastname: Corazza
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D002648:Child; D004643:Emollients / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D060046:Maintenance Chemotherapy; D055118:Medication Adherence; D008875:Middle Aged; D000068656:Mometasone Furoate; D011244:Pregnadienediols / Q000627:therapeutic use; D012074:Remission Induction; D055502:Secondary Prevention; D013997:Time Factors; D014810:Vitamin E / Q000627:therapeutic use*; D014815:Vitamins / Q000627:therapeutic use*; D007724:Vulvar Lichen Sclerosus / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D004643:Emollients; D011244:Pregnadienediols; D014815:Vitamins; D000068656:Mometasone Furoate; D014810:Vitamin E
keywords: emollient; maintenance therapy; relapse; vitamin E; vulvar lichen sclerosus