title: Vulvovaginal photodynamic therapy vs. topical corticosteroids in genital erosive lichen planus: a randomized controlled trial.
abstract: BACKGROUND
  Genital erosive lichen planus (GELP) in women is a chronic inflammatory disease characterized by painful vulval and vaginal erosions. Topical photodynamic therapy (PDT) is increasingly used in premalignant and malignant diseases and may have an effect in inflammatory diseases.
  
  
  OBJECTIVE
  To assess the feasibility, efficacy and safety of hexyl 5-aminolevulinate-hydrocloride (HAL)-PDT in GELP.
  
  
  METHODS
  Forty women, diagnosed with GELP at a specialized vulva clinic, were randomized to one session HAL-PDT in vulva and/or vagina (n = 20) or daily applications of clobetasol propionate 0·05% ointment in vulva and optional hydrocortisone acetate 1·0% foam in vagina for 6 weeks (n = 20). After 6 weeks, all patients were allowed to use topical corticosteroids as needed. Clinical examinations were performed at weeks 0, 6 and 24, using a clinical score developed for the study. All patients wrote a weekly log on pain, topical corticosteroid use and adverse events.
  
  
  RESULTS
  Three patients, all in the corticosteroid group, withdrew from the study after 1-3 weeks. The mean reduction in clinical scores was similar in the PDT group and the corticosteroid group; 25% vs. 22% after 6 weeks (P = 0·787) and 35% vs. 38% after 24 weeks (P = 0·801). The mean reduction in pain visual analogue scale scores was 38% vs. 55% after 6 weeks (P = 0·286) and 39% vs. 12% after 24 weeks (P = 0·452). Patients in the PDT group reported significantly less topical corticosteroid use during weeks 7-24 than those in the corticosteroid group. No major adverse events were reported.
  
  
  CONCLUSIONS
  Vulvovaginal HAL-PDT seems to be an effective and safe treatment for GELP.
authors.affiliation: Norwegian National Advisory Unit on Women's Health, Oslo University Hospital, N-0424, Oslo, Norway.|Department of Dermatology, Oslo University Hospital, N-0424, Oslo, Norway.|Institute of Clinical Medicine, Oslo University Hospital, N-0424, Oslo, Norway.
authors.forename: A L O
authors.initials: AL
authors.lastname: Helgesen
authors.affiliation: Department of Internal Medicine, Oslo University Hospital, N-0424, Oslo, Norway.
authors.forename: T
authors.initials: T
authors.lastname: Warloe
authors.affiliation: Oslo Centre of Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, N-0424, Oslo, Norway.
authors.forename: A H
authors.initials: AH
authors.lastname: Pripp
authors.affiliation: Department of Gynaecology, Oslo University Hospital, N-0424, Oslo, Norway.
authors.forename: R
authors.initials: R
authors.lastname: Kirschner
authors.affiliation: Department of Pathology, Oslo University Hospital, N-0424, Oslo, Norway.
authors.forename: Q
authors.initials: Q
authors.lastname: Peng
authors.affiliation: Institute of Clinical Medicine, Oslo University Hospital, N-0424, Oslo, Norway.|Department of Gynaecology, Oslo University Hospital, N-0424, Oslo, Norway.
authors.forename: T
authors.initials: T
authors.lastname: Tanbo
authors.affiliation: Department of Dermatology, Oslo University Hospital, N-0424, Oslo, Norway.|Institute of Clinical Medicine, Oslo University Hospital, N-0424, Oslo, Norway.
authors.forename: P
authors.initials: P
authors.lastname: Gjersvik
mesh_terms: D000279:Administration, Cutaneous; D000282:Administration, Intravaginal; D000622:Aminolevulinic Acid / Q000008:administration & dosage / Q000009:adverse effects; D002990:Clobetasol / Q000008:administration & dosage / Q000009:adverse effects; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D008010:Lichen Planus / Q000188:drug therapy*; D008875:Middle Aged; D010778:Photochemotherapy / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage; D014623:Vaginal Diseases / Q000188:drug therapy*; D014845:Vulvar Diseases / Q000188:drug therapy*
chemical_list: D003879:Dermatologic Agents; D005938:Glucocorticoids; D014622:Vaginal Creams, Foams, and Jellies; C021650:hydrocortisone acetate; D000622:Aminolevulinic Acid; D002990:Clobetasol; D006854:Hydrocortisone