lyze the skin for roughness/texture, pigmentation, pore count/ size reduction, and redness (Visia-CRTM Facial Imaging System; Canfield Scientific, Parsippany, NJ). The investigator assessed treatment efficacy by using the following parameters: skin roughness/texture, pigmentation, pores, hydration, elasticity, redness, sebum, dirt removal, moisturization, clarity, smoothness, softness, firmness, texture, radiance, suppleness, and overall skin quality. Subjects rated treatment efficacy by using the following parameters: dullness, redness, oiliness, roughness, dryness, texture, tone, and overall skin quality. Each parameter was rated on a 5-point scale ranging from 0 (none) to 4 (severe) at baseline and weeks 2, 4, and 8. Using a second Subject Self-Assessment Questionnaire, subjects were asked to rate other aspects of skin quality at weeks 4 and 8, including appearance, smoothness, oiliness, pores, texture, color, and health, using the 5-point scale of 1 (strongly disagree/worse) to 5 (strongly agree/much improvement). Objective skin assessments were pin probe hydration (Derma- Lab Corneometer®; Hadsund, Denmark), elasticity (DermaLab Elasticity®; Hadsund, Denmark), sebum (Courage + Khazaka Sebumeter®; Cologne, Germany), and dirt removal (CuDerm D- Squame®; Dallas, TX). The investigator and subjects rated tolerability by using the following parameters: stinging, burning, itching, tightness, redness, flaking, roughness, irritation, dryness, and overall sensitivity. Efficacy and tolerability parameters were rated on a 5-point ordinal scale 0 (none) to 4 (severe) at baseline and weeks 2, 4, and 8.
During the baseline study visit, the investigator completed a skin condition and tolerability assessment and obtained a medical history. Noninvasive skin assessments performed at that time included skin hydration, elasticity, sebum, and cleanliness. Subjects were dispensed the study products and instructed on how to apply the cleanser each morning, followed by a scrub with the exfoliating polish and then an application of the oil control pads. Each evening, subjects were to cleanse the skin again and reapply the oil control pads. Subjects were permitted to use their own self-selected SPF 30+ sunscreen as needed. A daily diary was used to confirm compliance with study procedures.
The primary efficacy endpoint was the change in skin assess- ment following treatment with the study products. The safety endpoint was the overall incidence of all adverse events reported during the study, with tolerability based on investigator assessments of skin irritation.
A Wilcoxon signed-rank two-tailed paired test was used for lon- gitudinal analysis of all ordinal data as compared to baseline. A Student's t-test was used for all numerical instrumental data. Statistical significance was defined as P
Among the 35 enrolled subjects, two withdrew from the study. The remaining 33 subjects were Caucasian with a mean age of 51.1 years. No compliance issues were noted, and all collected data were included in the final analysis.
The results of the subject self-assessment questionnaires revealed significant improvement in each of the eight measures of skin quality (Figure 1). There were also consistent improvements in subject-assessed measures of skin quality, including appearance, smoothness, oiliness, pores, texture, color and