title: Cream with cutaneous fibroblast lysate for the treatment of provoked vestibulodynia:  a double-blind randomized placebo-controlled crossover study.
abstract: OBJECTIVE
  Is treatment of provoked localized vulvodynia with cutaneous lysate skin cream containing human cytokines effective?
  
  
  METHODS
  This is a double-blind placebo-controlled randomized crossover trial with a study and a placebo cream applied twice daily for 3 months, 1-week washout, followed by a 3-month crossover medication in 30 patients experiencing provoked localized vulvodynia with visible vulvar erythema. Tolerability of the product, sexual functioning, and clinical findings were the main outcomes. A linear model for repeated measures was used for all visits. Effect after 4 weeks of treatment, effect after 12 weeks of treatment, and, finally, carryover effects of first and second order were estimated. A Wilcoxon signed rank test was used to evaluate 4- and 12-week changes within a group, and Mann-Whitney U test was used to evaluate 4- and 12-week changes between groups.
  
  
  RESULTS
  Tolerability of the cream was excellent and not different from that of placebo. During the first 12 weeks, use of the active cream resulted in a significant reduction in pain during sexual activity after 4 and 12 weeks (p < .05); however, use of the placebo cream did not. When analyzing the entire pain data with the statistical model for crossover clinical study design, the active cream resulted in a decrease of 1.1 points (95% confidence interval = -0.6 to 2.8, p = .20) and 1.3 points (95% confidence interval = 0.1 to 2.5, p = .037) in the visual analog scale score compared with that of placebo after 4 and 12 weeks of treatment, respectively. There was evidence for a second-order carryover effect (p = .024). The pain reduction was most evident for women with secondary dyspareunia. Erythema was reduced after use of the cream at 4 (p = .03) and 12 (p = .01) weeks but not after placebo.
  
  
  CONCLUSIONS
  As opposed to placebo, use of cutaneous lysate cream was more effective in reducing focal redness and pain while having intercourse in patients with provoked localized vulvodynia with erythema.
authors.affiliation: Department of Obstetrics and Gynecology, Regional Hospital Heilig Hart, Tienen, Belgium. gilbert.donders@femicare.net
authors.forename: Gilbert G
authors.initials: GG
authors.lastname: Donders
authors.forename: Gert
authors.initials: G
authors.lastname: Bellen
mesh_terms: D000328:Adult; D002457:Cell Extracts / Q000008:administration & dosage*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005347:Fibroblasts / Q000737:chemistry*; D006801:Humans; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage*; D056650:Vulvodynia / Q000628:therapy*; D055815:Young Adult
chemical_list: D002457:Cell Extracts; D010919:Placebos; D014622:Vaginal Creams, Foams, and Jellies