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.

MODIFIED FCAT 159 product application in the FCAT, the need for a conditioning or pretreatment period, and the overall test duration required to achieve significant differences between prod- ucts. In addition, the final experiment in this phase incorporated the optimum patch system (the J&J bandage system) developed in the previous studies. Experiment 1--FCAT without hydration. The objective of this experiment was to confirm that the FCAT was sensitive enough to detect mildness differences in baby wipe prod- ucts on normal (non-hydrated) skin. The effects of three different products were com- pared to an untreated control. In this study, panelists underwent a one-week condition- ing period prior to the start of the test during which they were asked to stop using any lotions, cremes, moisturizers, soaps, or other products on the test sites. Following the one-week conditioning period, the FCAT ran for five days. Four washing sessions were conducted on days 1-4, and two were conducted on day 5. Each washing session was a total of 30 seconds, with the exception of the final cycle on each day, which was 60 seconds. Instrumental measurements were conducted prior to the first washing session on day 1, and after the final washing session on day 5. Visual scoring for erythema and dryness was conducted prior to the first and third washing sessions on days 1-4, prior to the first washing session on day 5, and at the completion of the study (following the second washing session on day 5). Five-point scales (0-4) were used for erythema and dryness. The washing procedure was terminated at any test site with a visual score for either erythema or dryness of --3. If an early termination was necessary, instrumental mea- surements were conducted at that site at the time of termination. These measurements were carried through to the end of the study. Table II gives the final visual and instrumental scores. None of the untreated control sites or sites treated with Product A required early termination. For sites treated with products C and D, early terminations were required for 14% and 46%, respectively, of the 31 panelists who completed the study. For all four endpoints, product C was significantly less mild than product A. In addition, product D was less mild than Table II Comparison of Three Baby Wipe Products on Non-Hydrated Skin in the Five-Day FCAT Final visual scores Final instrumental scores Early Treatment terminations • Erythema Dryness Redness (a*) TEWL (g/m 2 hr) Untreated 0% 0.11 + 0.24 0.15 + 0.23 9.2 + 1.2 3.16 + 1.2 Product A 0% 0.3 + 0.31 0.23 + 0.26 9.4 + 1.2 4.5 + 1.6 Product C 14% 1.28 + 0.89 b 0.51 _+ 0.29 c 10.8 + 1.6 d 10.7 + 4.8 d Product D 46% 2.13 + 0.92 0.62 + 0.34 12.5 + 1.9 e 15.9 -+ 7.1 e This five-day study compared products A, C, and D on non-hydrated (normal) skin only. Four washing sessions were conducted on days 1-4, and two were conducted on day 5. Data for the final scores are given above (mean + SD). 31 panelists completed the study. a The washing procedure was terminated due to a visual score of •3 at the test site. b Significantly different from Product A (p 0.0001) using Wilcoxoh's matched-pairs test. c Significantly different from Product A (p 0.001) using Wilcoxoh's matched-pairs test. • Significantly different from untreated control, and Products A and D (p 0.01) using Tukey's protected t-test. e Significantly different from untreated control, and Products A and C (p 0.01) using Tukey's protected t-test.