title: A randomized, controlled trial comparing skin health effects and comfort of two adult incontinence protective underwear.
abstract: OBJECTIVE
  It is important to confirm product use effects on skin health for products intended for prolonged skin contact. This study compared experimental and marketed reference adult incontinence protective underwear.
  
  
  METHODS
  Randomized, single-blind (examiner), parallel study evaluating skin health effects in predominantly obese incontinent women normally using protective underwear (approximately 20% Type II Diabetes). Subjects wore experimental or marketed reference protective underwear daily, 14 consecutive days. Visual skin grading, transepidermal water loss (TEWL) assessed before, after 1 and 2 weeks of product wear. Overall assessment of comfort assessed.
  
  
  RESULTS
  Of the 122 subjects (60 experimental and 62 marketed reference), 22 were diabetic and 88 were postmenopausal. Under the conditions of this study, there were no statistically significant differences in overall change from baseline for visual grading and TEWL between the experimental product and the marketed reference product for all subjects. Changes from baseline for skin erythema and skin marking were generally small for both products for all subjects as well as for both diabetics and non-diabetics. There were no serious adverse events (AEs), and no withdrawals due to AEs. Overall comfort assessments of size and fit were 'just right,' and skin comfort in the leg, waist and crotch areas were 'comfortable' or 'very comfortable' for both products.
  
  
  CONCLUSIONS
  In-use 14-day testing demonstrated few statistical differences between experimental product with unique odor neutralizing technology and currently marketed product for skin assessments and comfort. Both products were comfortable and well-tolerated.
authors: Department of Global Clinical Sciences, The Procter & Gamble Co, Cincinnati, OH, USA.
authors: M M
authors: MM
authors: Trowbridge
authors: Department of Quantitative Sciences, The Procter & Gamble Co, Cincinnati, OH, USA.
authors: B
authors: B
authors: Wang
authors: Department of Central Product Safety, The Procter & Gamble Co, Cincinnati, OH, USA.
authors: D
authors: D
authors: Gutshall
authors: Department of Quantitative Sciences, The Procter & Gamble Co, Cincinnati, OH, USA.
authors: C A
authors: CA
authors: Rodenberg
authors: Department of Global Clinical Sciences, The Procter & Gamble Co, Cincinnati, OH, USA.
authors: M A
authors: MA
authors: Farage
mesh_terms: D015984:Causality; D015897:Comorbidity; D003877:Dermatitis, Contact / Q000453:epidemiology* / Q000517:prevention & control; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D006801:Humans; D016496:Incontinence Pads / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D000070659:Patient Comfort; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D015995:Prevalence; D011481:Protective Clothing / Q000706:statistics & numerical data*; D012307:Risk Factors; D016037:Single-Blind Method; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000453:epidemiology* / Q000451:nursing*
keywords: diabetes; erythema; female incontinence; protective underwear; skin health; transepidermal water loss