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.
Background/Purpose
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.
We can conclude that pretreatment with 110 μg/cm lotion acts as a barrier to high pH fluids such as urine. Using the measurement of lotion transfer from the AI products, together with the results of studies conducted to determine the concentration of lotion required to provide specific skin benefits, we conclude that the five-stripe lotion configuration AI test products transferred enough lotion (ie, ≥80 μg/cm ) to provide skin protection with regard to: (1) irritant effects and (2) excess moisture. The single-block AI test products also transferred enough lotion to provide these skin benefits (ie, ≥165 μg/cm ), and the additional benefits of skin protection against: (3) dryness, and (4) changes in pH.
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