MODIFIED FCAT 157 compared to the non-treated control. If significant differences existed, multiple com- parisons were done using Tukey's protected t-test, which allows one to examine differ- ences between treatment pairs. Scores for erythema and dryness were analyzed by a Wilcoxon's matched-pairs test. In the second experiment in the FCAT modification phase, Wilcoxon analysis was used to compare products A and C with regard to erythema, dryness, chromameter readings (redness), and TEWL. In the third experiment in the FCAT modification phase, a Wilcoxon's signed rank test was used to compare erythema, dryness, and TEWL. Chromameter readings (redness) were analyzed using a two-sided paired t-test. In addition, analysis of covariance using baseline readings as the covariate was used to evaluate TEWL and chromameter readings. RESULTS PATCH DEVELOPMENT PHASE The first three experiments in this phase were designed to determine an effective and practical way to achieve a hydrated environment at the skin test sites. In these experi- ments, either synthetic urine or distilled water was used in combination with various semi-occlusive patches worn overnight (approximately 20 hours) to achieve a hydrated environment at the skin site. The TEWL was measured at the test sites prior to patch application (baseline), immediately upon removal of the patch system, and 90 minutes after patch removal. In these experiments, an increase in TEWL over baseline levels was interpreted as an indication of skin barrier damage. Distilled water versus synthetic urine. In experiments 1 and 2, the effects of water were directly compared to the effects of synthetic urine using two different patch systems: the modified diaper patch containing 60 ml of fluid, and the J&J bandage alone containing 9 ml of fluid. Several panelists lost patches during the night. In addition, subjects who took a morning shower had patches that became saturated, indicating a lack of occlusion. These subjects were excluded from the final data. TEWL readings immediately after patch removal for those subjects whose patches remained intact indicated that water and synthetic urine produced similar results using either the modified diaper patch or the J&J bandage (data not shown). Patch system. In experiment 2, the modified diaper patch was compared to the J&J bandage used alone. Immediately after patch removal, the modified diaper patch moist- ened with water showed a mean TEWL reading of 15.00 + 5.94 g/m2hr. This was considerably higher than the reading produced by the J&J bandage (4.65 + 1.77 g/m2hr), indicating that the J&J bandage was less effective at hydrating the skin. In experiment 3 four modifications of the J&J bandage patch were compared: the J&J bandage alone, the J&J bandage secured with reinforcing tape, the J&J bandage supple- mented with gauze, and the J&J bandage with gauze and tape (referred to as the J&J bandage system). The J&J bandage system resulted in the highest TEWL readings of all four modifications (17.15 + 0.64 g/m2hr). These readings were similar to those produced by the modified diaper patch. Pilot for modified FCAT. Experiment 4 was an abbreviated modified FCAT designed (a)

158 JOURNAL OF COSMETIC SCIENCE to confirm the effectiveness of the J&J bandage system (i.e., J&J bandage with gauze and reinforcing tape containing 10 ml distilled water) compared to the modified diaper patch (containing 60 ml distilled water) in creating a hydrated skin environment, and (b) to provide preliminary data that the test system will distinguish between two baby wipe products that differ in skin mildness. This three-day experiment involved four washing sessions with test products A and C on days 1 and 2, and a single washing session on day 3. All washing sessions were 30 seconds except the final session on each day, which was 60 seconds. After the final washing session on days 1 and 2, patches were applied to test sites and worn overnight. Erythema was scored prior to the first washing session on all days, prior to the fourth washing session on days 1 and 2, and at the completion of the study. TEWL readings were taken prior to the first washing session on day 1, after the second washing session on day 2, and at completion of the study. Results of this experiment are presented in Table I. For Product C, the three-day duration of this experiment was sufficient to produce statistically significant differences in the TEWL readings at both the intermediate and final readings when compared to the baseline readings with the modified diaper patch. When the J&J bandage system was used, the TEWL readings increased with time, but the differences were not statistically significant. For Product A, there were no significant differences between intermediate or final readings compared to the baseline readings with either the modified diaper patch or the bandage patch system. When the scores for product A were compared to those for product C, there were no significant differences between products at any of the three time points (baseline, in- termediate, or final) with either patch system. FCAT MODIFICATION PHASE The experiments in this phase were designed to examine the specific duration of test Table I Comparison of Two Baby Wipe Products in the Three-Day FCAT Pilot With Hydration of Test Sites Using Two Patch Systems TEWL (mean g/m 2 hr + SD) Modified diaper patch with 60 ml water j&j bandage system with 10 ml water Baseline Intermediate Final Baseline Intermediate Final (n = 5) a (n = 5) (n = 4) (n = 5) (n = 5) (n = 4) Product A 6.2 + 0.84 5.4 + 1.67 6.75 + 1.50 5.8 + 0.84 6 + 0.71 6.75 + 0.50 Product C 4.8 + 1.64 5.8 + 0.45 7.25 + 0.50 b 4.8 + 1.3 6.2 ñ 1.48 6.5 ñ 1.29 This three-day experiment compared products A and C using the modified diaper patch and the J&J bandage system. One test site on each arm was subjected to four washing sessions with either test product A or C on days I and 2, and a single washing session on day 3. After the final washing session on days 1 and 2, patches were applied to test sites and worn overnight. The modified diaper patch was applied to one test site for each product, and the J&J bandage system was applied to the other site. TEWL readings were taken prior to the first washing session on day I (baseline), after the second washing session on day 2 (intermediate), and at completion of the study (final). a Number of panelists. b Significantly different from baseline (p = 0.025) and intermediate (p = 0.005) using a Student's t-test.