title: An investigator blinded cross-over study to characterize the cutaneous effects and suitability of modern sanitary pads for menstrual protection for women residing in the USA.
abstract: BACKGROUND
  The cutaneous and sensory effects of the practical usage of sanitary pads have been studied globally. However, clinical studies in the United States were conducted only quite a long time ago, and the results of these studies were not published.
  
  
  METHODS
  Fifty-four women residing in the United States were asked to use commercially available sanitary pads with a nonwoven unique surface sheet and pads with a perforated film. This was a cross-over study design conducted over the course of two menstrual periods. A board certified dermatologist evaluated the levels of erythema and fissuring, burning, stinging and itching sensations based on clinical observations and interviews. Measurement of pH and swabs for bacteria counting of vulvar skin were also performed. Data from the first clinical evaluation conducted prior to the first menstrual cycle were used as the baseline. At the end of the study, the subjects were asked to complete self-assessment questionnaires about product suitability.
  
  
  RESULTS
  Forty-two women (age: 18-50, mean: 37.5) completed the study. No signs of irritation or meaningful differences from the baseline were found in the clinical observations or in the interviews by the dermatologist for either product. No significant difference from baseline was found in the vulvar skin surface pH or in the number of total bacteria for either product. The results of the suitability indicated that the majority of subjects were highly satisfied with both types, but they especially preferred the sanitary pad with a nonwoven unique surface top sheet.
  
  
  CONCLUSIONS
  These results revalidate the results of a previous clinical study in the United States and are consistent with recent reports of worldwide clinical trials of high performance sanitary pads.
authors.affiliation: Kao Corporation, Biological Science Laboratories, Haga, Tochigi, Japan. fujimura.tsutomu@kao.co.jp
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Fujimura
authors.forename: Noriko
authors.initials: N
authors.lastname: Sato
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Takagi
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ohuchi
authors.forename: Hironori
authors.initials: H
authors.lastname: Kawasaki
authors.forename: Takashi
authors.initials: T
authors.lastname: Kitahara
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Takema
authors.forename: Ronald L
authors.initials: RL
authors.lastname: Rizer
mesh_terms: D041342:Absorbent Pads / Q000009:adverse effects / Q000706:statistics & numerical data; D000293:Adolescent; D000328:Adult; D001420:Bacteria, Aerobic / Q000302:isolation & purification; D018592:Cross-Over Studies; D017453:Dermatitis, Irritant / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology*; D005260:Female; D006801:Humans; D006863:Hydrogen-Ion Concentration; D052576:Menstrual Hygiene Products / Q000009:adverse effects / Q000706:statistics & numerical data; D008598:Menstruation; D008875:Middle Aged; D017060:Patient Satisfaction; D011358:Product Surveillance, Postmarketing; D011795:Surveys and Questionnaires; D014481:United States; D016585:Vaginosis, Bacterial / Q000453:epidemiology / Q000382:microbiology; D014844:Vulva / Q000382:microbiology; D055815:Young Adult