title: Topical betamethasone and hyaluronidase in the treatment of phimosis in boys: a double-blind, randomized, placebo-controlled trial.
abstract: OBJECTIVE
  To compare the efficacy of three different formulations containing Betamethasone Valerate versus placebo in the topical treatment of phimosis. As a secondary goal, we compared the outcomes after 30 and 60 days of treatment.
  
  
  METHODS
  Two hundred twenty boys aged 3 to 10 years old with clinical diagnosis of phimosis were enrolled. Patients were randomized to one of the following groups: Group 1: Betamethasone Valerate 0.2% plus Hyaluronidase; Group 2: Betamethasone Valerate 0.2%; Group 3: Betamethasone Valerate 0.1% or Group 4: placebo. Parents were instructed to apply the formula twice a day for 60 days and follow-up evaluations were scheduled at 30, 60 and 240 days after the first consultation. Success was defined as complete and easy foreskin retraction.
  
  
  RESULTS
  One hundred ninety-five patients were included at our final analysis. Group 1 (N = 54), 2 (N = 51) and 3 (N = 52) had similar success and improvement rates, all treatment groups had higher success rates than placebo (N = 38). After 60 days of treatment, total and partial response rates for Groups 1, 2 and 3 were 54.8% and 40.1%, respectively, while placebo had a success rate of 29%. Success and improvement rates were significantly better in 60 days when compared to 30 days.
  
  
  CONCLUSIONS
  Betamethasone Valerate 0.1%, 0.2% and 0.2% in combination with Hyaluronidase had equally higher results than placebo in the treatment of phimosis in boys from three to ten years-old. Patients initially with partial or no response can reach complete response after 60 days of treatment.
authors.affiliation: Department of Urology, ABC Medical School, Santo Andre, SP, Brazil. fabiojnascimento@terra.com.br
authors.forename: Fabio J
authors.initials: FJ
authors.lastname: Nascimento
authors.forename: Rodrigo F
authors.initials: RF
authors.lastname: Pereira
authors.forename: Jarques L
authors.initials: JL
authors.lastname: Silva
authors.forename: Alessandro
authors.initials: A
authors.lastname: Tavares
authors.forename: Antonio C L
authors.initials: AC
authors.lastname: Pompeo
mesh_terms: D000287:Administration, Topical; D001624:Betamethasone Valerate / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D006821:Hyaluronoglucosaminidase / Q000008:administration & dosage*; D008297:Male; D010688:Phimosis / Q000188:drug therapy*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D001624:Betamethasone Valerate; D006821:Hyaluronoglucosaminidase