156 JOURNAL OF COSMETIC SCIENCE varied slightly, but all were between 66 ø and 72øF, and 30% and 50% relative humid- ity. In all studies, individuals with a TEWL reading of 7.5 g/m2hr at baseline (i.e., prior to the first patch application) were excluded from the study. A Minolta Chromameter CR-200 © was used to score redness. A complete description of the use of this instrument for similar applications has been given previously (9). Briefly, this instrument reads color in a three-dimensional format along coordinates L*, a*, and b*. Coordinate L* indicates the level of brightness between black and white. Coordinate a* indicates the red-green balance (with 100 being red only and - 100 being green only). Coordinate b* indicates the yellow-blue balance. For this program, the reading along the a* coordinate was of greatest interest since higher a* values indicate greater irritation. Measurements were obtained by gently resting the aperture of the measuring probe on the skin surface. The L*a*b* values were directly inputted to a personal computer. Triplicate a* readings were taken at each test site. Visual scoring was conducted by expert graders under a 100-watt incandescent daylight bulb. For each study, a single expert grader was used throughout the study. Persons scoring the test sites were unaware of the specific treatment at each test site. In the first study in the FCAT modification phase, dryness and erythema were graded on scales of 0-4, with "0" indicating perfect skin and "4" indicating a severe reaction. In all other studies, these scales were expanded to the seven-point scales given below. Erythema grading scale 0 = none 1 = barely detectable redness 2 = slight redness 3 = moderate redness 4 = heavy or substantial redness 5 = severe redness 6 = extreme redness Dryness grading scale 0 = none 1 -- patchy, slight powderiness, small scales 2 = general, slight powderiness, small lifting scales 3 = general, moderate powderiness, cracking and scales 4 = general, heavy powderiness and cracking, lifting scales 5 -- heavy cracking (possibly bleeding) and lifting scales 6 = severe scaling, bleeding cracks, sloughing of large scales Fractional increments were assigned to slight differences or intermediate responses when two test sites were compared at a single grading point. Statistical analyses of data. In the patch development phase studies, the Student's t-test was used to compare two treatments. When three or more treatments were being evaluated, an analysis of variance (ANOVA) was used. If the ANOVA indicated that the groups were significantly different, a Student's t-test between treatment pairs was conducted. In the first experiment in the FCAT modification phase, instrumental measurements were evaluated by a repeated ANOVA run on the values obtained from the treated sites

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)