title: Mometasone fuoroate 0.1% ointment in the treatment of vulvar lichen sclerosus: a study of efficacy and safety on a large cohort of patients.
abstract: BACKGROUND
  Guidelines identify a 3-month topical application of an ultra-potent corticosteroid ointment as the mainstay of medical treatment for vulvar lichen sclerosus (VLS). However, there are no trials providing evidence that any specific corticosteroid is superior to another.
  
  
  OBJECTIVE
  To assess the effectiveness and safety of a 12-week application of mometasone furoate (MMF) 0.1% ointment, with a tapering regimen, in achieving control of VLS signs and symptoms and to detect potential risk factors for VLS non-response.
  
  
  METHODS
  147 patients affected with VLS were enrolled in a 12-week active treatment phase (ATP) with topical 0.1% MMF. The primary efficacy endpoint was the rate of patients achieving clinical response, as defined by protocol parameters. The secondary efficacy endpoint was to assess the changes of mean VLS-related symptoms after the 12-week ATP compared with baseline.
  
  
  RESULTS
  By the end of the ATP, 113 patients (80.7%) experienced a treatment response, whereas 27 women (19.3%) were judged as non-responders. Mean symptom scores decreased significantly in the study patients, regardless of their clinical response at the end of the ATP. Among all the epidemiological and clinical data considered, only the absence of previous medical therapies was found to be related to a significantly higher risk of non-response to treatment.
  
  
  CONCLUSIONS
  Application of 0.1% MMF ointment for 12 weeks on a tapering regimen was found to be an effective and safe therapy option in the ATP of VLS and could represent an alternative first-line treatment to an ultra-potent molecule.
authors.affiliation: Department of Medical Sciences, Section of Dermatology, University of Ferrara, Ferrara, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Virgili
authors.forename: A
authors.initials: A
authors.lastname: Borghi
authors.forename: S
authors.initials: S
authors.lastname: Minghetti
authors.forename: M
authors.initials: M
authors.lastname: Corazza
mesh_terms: D000287:Administration, Topical; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008137:Longitudinal Studies; D008875:Middle Aged; D000068656:Mometasone Furoate; D009824:Ointments; D061214:Patient Safety; D011244:Pregnadienediols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome; D007724:Vulvar Lichen Sclerosus / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D009824:Ointments; D011244:Pregnadienediols; D000068656:Mometasone Furoate