TOPICAL MOISTURIZERS 81 FOREHEAD -••( AND UNDER "• '• .... k, ....... CHEEK • • AND MOUTH CHIN Figure 1. Scoring areas of the face Number and depth Frequency Rating x Depth Rating = Score 4 very shallow 2 1 2 2 shallow 1 2 2 1 deeper 1 3 3 -- SFL score for the area = 7 The scores for the four component areas are summed to arrive at the score for the full half-face. Two judges instead of one were used to provide a check on observer variation. Their training, conducted by a dermatologist, was intended to ensure uniform conditions of evaluation, such as equivalent definition of the individual facial areas from subject to subject, correct determination of frequency and depth under uniform conditions of lighting (from above) and distance (2 ft), accurate classification of lines as very shallow, shallow, deeper, or else as not SFL's, and familiarity with the requirements of a con- trolled scientific investigation. Both judges possessed normal visual acuity, relied on no magnification, and evaluated independently of each other without knowing the nature of the treatments used.
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.
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