82 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS SUBJECTS Twenty women, from 30 to 65 years old, were chosen for the study after initial de- termination that they were free of influencing diseases or allergies, and had SFL scores for the full face of 20 minimum and preferably 30 or moderately higher. This range of ages and scores excluded individuals with too few lines or with more lines than are representative of the general population. Each subject took part in each of the test series described below. STUDY DESIGN This half-face, single-blind study comprised five test series as follows: Series I Series II Series III Series IV Series V No treatment rs. water Moisturizer O vs. water Moisturizer O vs. Moisture Lotion ML Moisturizer O vs. Moisture Film MF Moisturizer O vs. Lotion L.• We defined the extent of reproducibility in four different ways: 1. via comparison of baseline values by facial area and full half-face on Day 0 (no treatment) for the group of 5 series 2. via comparison of baseline values on Day 0 for individual test series 3. via comparison of inter-observer variation on the no-treatment day 4. via comparison of the reductions achieved when the same moisturizer (O) was used in four of the test series. Once assured as to the reliability of the method, we could then test its sensitivity by examining any differing responses through time of individual facial areas in conj unc- tion with application of the moisturizers, water, or no treatment. TREATMENT AND EVALUATION SCHEDULES Each series consisted of an initial no-treatment day, followed by three successive treat- ment days (Days 1, 2, 3). Application of the coded treatments was randomized by side of the face, through the study group, and through all test series. Test agents were ap- plied on each treatment day to the designated half-face in the morning after the 0-hr evaluation and in the evening after the 10-hr evaluation, with the appropriate follow- up to ensure that the correct coded preparation had been used in accordance with the randomization instructions. The subjects did not use any other cosmetics or toiletries on the study areas. The SFL's were rated by the two trained judges at 0, 3, 6, and 10 hr on each no-treatment and treatment day, in accordance with the system described above. Three or more nonstudy days elapsed between treatment series to allow SFL values to return to baseline. This study took place in the fall (mid-October to December) to avoid the complicating effects of warm weather. x O is Oil of Olay © (Olay Company, Inc., Wilton, Conn. 06897), containing a blend of fatty alcohols (cetyl, myristyl, and stekryl), cetyl palmirate, sodium and potassium laurares, myristates, stearates, and palmitates, mineral and castor oils, and cholesterol, in a preserved and fragranced vehicle, ML, MF, and L are marketed oil-in-water emulsions.
TOPICAL MOISTURIZERS 83 Table I Baseline (No Treatment) Reproducibility by Facial Area SFL Score Ranges, Day 0 (All Series) Facial Area 0 hr 3 hr 6 hr 10 hr Forehead 4.1-4.7 4.1-4.6 4.1-4.6 4.1-4.6 Around the Eyes 7.4-8.0 7.2-7.9 7.2-8.0 7,4-8.0 Cheek and Mouth 3.9 -4.2 3.8-4.2 3.9-4.1 3.9-4.2 Chin 2.3-2.8 2.2-2.7 2.2-2.7 2.2-2.8 Full half-face 17.7-19.7 17.3-19.4 17.4-19.4 17.6-19.6 RESULTS 1. REPRODUCIBILIT¾ OF THE METHOD Baseine values by facial areas and full half-face. Table I shows the ranges for both judges' separate scores on Day 0, averaged for the 20 subjects over the 5-test series. The ranges differed among the different facial areas, but for a particular area or for the full half-face they varied relatively little. Baseline values by test series. Table II shows the summed scores of both judges for the full half-face, by individual test series for the no-treatment day. These scores range from a high of 38.3 to a low of 35.4. Baseline values by judge. In Table III, the above scores are broken down by individual judge (shown for one side of the face only, for convenience) to depict the level of inter- observer variation on the no-treatment day. The scores for the other side showed a similar range of variation. Effect of the same agent through multiple series. Use of the same moisturizer (O, Olay) in four series (II, III, IV, V) provided a test of reproducibility among series, when the values at successive time intervals within a particular series were changing. A similar pattern of change through time was detected in the 4 series, as can be seen from Table IV. Table II Baseline (No Treatment) Reproducibility by Test Series Summed SFL Scores (Both Judges), Day 0 of Each Series 0 hr 3 hr 6 hr 10 hr Series I Half-face 38.3 37.9 37.9 38.2 Opposite half-face 38.1 37.9 37.5 37.6 Series II Half-face 35.9 35.5 35.4 35.7 Oppo sire h alf-face 35.9 35.5 35.5 36.0 Series III Half-face 37.0 36.0 35.8 36.5 Opposite half-face 37.2 37.0 36.9 37.2 Series IV Half-face 36.9 36•2 36.3 37.0 Opposite half-face 38.1 37.9 37.8 38.0 Series V Half-face 37.0 36.3 36.2 36.9 Opposite half-face 38.2 37.9 38.0 38.0 Average 37.3 36.8 36.7 37.1 +- SD +-2.7 -+3.1 +-3.1 +-2.5
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