MODIFIED FCAT 163 scores for dryness showed a similar pattern. One goal of this program was to develop a practical, cost-effective test method for measuring mildness differences on hydrated skin. Therefore, statistical analyses were conducted on the intermediate scores to determine if an experiment of shorter duration would provide statistically significant results for all endpoints. Recorded scores at all time points starting with day 5 (scoring time point 10) in the 14-day experiment were analyzed. A summary of the days that yielded statistically significant results is shown in Table V. As shown in this table, the study consistently yielded statistically significant results for all endpoints except dryness on both normal and hydrated skin at all time points starting at day 5. After nine days, the dryness endpoint was also significantly different. The instrumental measurements were con- ducted on days 5 and 14, and were significantly different on both days. DISCUSSION A Modified FCAT has been developed that is capable of producing statistically signifi- cant differences between different baby wipe products in erythema, dryness, redness, and TEWL on both hydrated and normal skin. A patch system was developed for hydrating the skin that was convenient, cost-effective, and well accepted by the panelists. The first three experiments in the patch system development phase demonstrated that distilled water was roughly equal in effectiveness to synthetic urine in producing a hydrated environment, and a patch consisting of the J&J bandage with gauze and Blenderm tape provided adequate hydration when compared to the other patch systems tested, includ- ing the modified diaper patch. Panelist acceptance was an important consideration for the patch system. Comments were solicited from the panelists with regard to the comfort and wearability of the various patch systems. The modified diaper patch was not well received. It was consid- ered too large and unsightly for a test requiring several days. The 60 ml of fluid required to saturate the patch made the patch too heavy to be worn comfortably. Bathing with the modified diaper patches resulted in patches soaked with water. Not only did this contribute to panelist discomfort, it resulted in spuriously high TEWL readings, neces- sitating exclusion of some subjects from the final analysis. In addition, the modified diaper patches had to be hand cut from commercial diapers, which added considerably to the overall study costs. The patches using the J&J bandage were well received by the panelists however, without reinforcing tape these did not stay in place overnight for some, resulting in several panelists being dropped from these study groups. The gauze was a necessary addition in order to achieve a skin environment similar to that achieved with the modified diaper patches. In the FCAT modification phase, the study summarized in Table II confirms that the FCAT has enough sensitivity to detect differences in the skin effects of products on normal (non-hydrated) skin in an experiment of only five days' duration. However, we expected that differences in mildness would be more challenging to detect on hydrated skin due to the background level of irritation. This increased level of irritation is demonstrated in Tables III and IV. In every instance but one (TEWL scores for Product

164 JOURNAL OF COSMETIC SCIENCE 3.00 -- 2.50 2.00 1.50 1.00 0.50 0.00 .... Product ._ ./ø . 3.00. I 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Scoring Time Point 2.50. ---- Product 2.00 ........... • 1.50 1.00 /'/ 0.50 0.00 I 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 b Scoring Time Points Figure 1. 14-Day Modified FCAT: Visual Scores for Erythema for Products B and C. In this test of 14 days' duration, products were compared on both normal (a) and hydrated (b) skin. Visual scoring was conducted twice daily (i.e., prior to the first and third washing cycle of each day). Therefore, scoring time points 1 and 2 occurred on day 1, scoring time points 3 and 4 occurred on day 2, etc. Data for the final scores for all four parameters (erythema, dryness, redness, and TEWL) are given in Table IV.