title: Assessing the dermal compatibility of a new female incontinence product line.
abstract: BACKGROUND
  We have developed a line of products designed to better meet the overall needs of women suffering from urinary incontinence. The products are more discrete and contain a unique odor neutralizing technology (ONT).
  
  
  OBJECTIVE
  This paper describes the overall skin compatibility program for this product line in which the new products were compared to negative controls and/or commercially marketed reference products with an established history of safe use.
  
  
  METHODS
  Test products consisted of several product forms (light pads/pantiliners, moderate pads, briefs and taped diapers) with ONT and having various degrees of protection. Studies were conducted using standard protocols for 4-day and 21-day cumulative irritation, the Human Repeat Insult Patch Test (HRIPT), and the Behind-the-Knee (BTK) test for mechanical and chemical irritation. In one 4-day irritation study and one HRIPT, test subjects consisted of individuals with self-assessed sensitive skin. In addition, one 4-day study was conducted using normal skin sites, and sites compromised by tape stripping. Nonirritant controls were physiologic saline and/or current, commercially marketed incontinence products. All responses were evaluated by visual scoring of erythema. In addition, in the BTK, transepidermal water loss (TEWL) and adverse sensory effects collected from panelists' daily diaries were also evaluated.
  
  
  CONCLUSIONS
  Two 4-day cumulative irritation studies and one 21-day study demonstrated that a wide range of product forms (liners, light and moderate pads, briefs and adult diapers) produced skin reactions similar to the nonirritant controls. The 4-day study conducted using sensitive skin subjects showed good skin compatibility, and the test products were comparable to the nonirritant controls. In the 4-day study with both normal and compromised skin sites, test products produced mean erythema scores similar to the nonirritant controls. Three HRIPT separate studies confirm that the products do not induce contact sensitization, including one study conducted on individuals with self-assessed sensitive skin. In the BTK, test and control products produced similar irritation, as assessed by erythema, TEWL and sensory effects.
  
  
  CONCLUSIONS
  The results from the patch tests and mechanical irritation test demonstrate good skin compatibility of the new line of products with the unique ONT. In addition, the forms of the product (i.e. liner, pad or brief), were equally compatible with skin.
authors.affiliation: a Central Product Safety .
authors.forename: Denise
authors.initials: D
authors.lastname: Gutshall
authors.affiliation: a Central Product Safety .
authors.forename: Shaoying
authors.initials: S
authors.lastname: Zhou
authors.affiliation: b Statistics and Data Management .
authors.forename: Baiyang
authors.initials: B
authors.lastname: Wang
authors.affiliation: c Global Clinical Sciences , and.
authors.forename: Miranda A
authors.initials: MA
authors.lastname: Farage
authors.affiliation: d Fem Care Global Product Stewardship , Procter & Gamble , Cincinnati , OH , USA.
authors.forename: Anne E
authors.initials: AE
authors.lastname: Hochwalt
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D053566:Hygiene Products; D006801:Humans; D008297:Male; D008875:Middle Aged; D010328:Patch Tests; D011108:Polymers / Q000633:toxicity; D012867:Skin / Q000187:drug effects; D023422:Skin Irritancy Tests; D014549:Urinary Incontinence; D055815:Young Adult
chemical_list: D053566:Hygiene Products; D011108:Polymers
keywords: Behind-the-Knee; consumer product safety; contact sensitization; cumulative irritation; incontinence products; sensitive skin; skin compatibility; skin safety