were taken of the complete front face at rest and at maximum smile with eyes open. Subjects were placed in a Canfield 3-point head mount with Canfield designed Nikon camera and flash system. Subjects were given a diary at the baseline visit to record their twice daily application and for compliance checks. At each study visit, the amount of study product remaining was checked along with the diary entries, and the unused product was weighed for compliance purposes.
A two-tailed Mann Whitney t-test was used to analyze the nonparametric data sets with significance set at P<0.05. A longitudinal analysis was performed in the monadic study with each time point compared with baseline where study products were initiated except for the peptide treatment serum. Concerning the peptide treatment serum, baseline is considered
to be the 2 week time point when this product application was initiated after the washout period.
RESULTS
Clinical Grading of Efficacy Parameters: Expert Investigator Evaluation at Rest
By week 2, the regimen had produced a highly statistically significant improvement in skin smoothness and softness (P<0.001) when compared to baseline results. The peptide treatment serum was added for morning and evening application at week 2 and applied from the lower eyelids up to the forehead, but not the upper eyelid. At week 6, a highly statistically significant improvement in smoothness and softness (P<0.001) continued, with additional statistically significant improvement in firmness and radiance P<0.001), luminosity (P=0.003), and overall appearance (P<0.001) when compared to baseline results.
Improvement continued throughout the study period. At week 10, there was a highly statistically significant (P<0.001) improvement in smoothness, softness, firmness, radiance, luminosity, and overall appearance when compared to baseline results; there was also a significant improvement in eye lines (P=0.003) and eye wrinkles (P=0.007) compared to baseline results. At week 14, there was significant improvement in facial lines (P=0.006), facial wrinkles (P=0.018), eye lines (P<0.001), and eye wrinkles (P=0.001) when compared to baseline results. In addition, there was continued highly statistically significant improvement (P<0.001) in smoothness, softness, firmness, radiance, luminosity, and overall appearance when compared to baseline results (Table 1).
Clinical Grading of Efficacy Parameters: Expert Investigator Evaluation at Maximum Smile
At week 6, there was a significant improvement in eye lines (P=0.025) compared to baseline results when smiling. This improvement continued into week 10 where there was significant improvement in facial lines (P=0.043), eye lines (P=0.005), and eye wrinkles (P=0.014) when compared to baseline results. Continued improvement was seen at week 14 in facial lines (P=0.018), eye lines (P<0.001), and eye wrinkles (P=0.006) when compared to baseline results (Table 2).
Aesthetic Attributes of Products Other Than Serum: Subject Assessment at Week 14
The subjects were asked to rank several attributes of the products other than the peptide treatment serum at week 14 on a numeric scale (0=strongly agree, 1=agree, 2=neutral, 3=disagree, and 4=strongly disagree). The subjects agreed that the product smell (mean=0.55), texture (mean=0.52), and ease of application (mean=0.59) were excellent. They also strongly agreed that the product did not cause irritation (mean=0.34), and that they would purchase the product (mean=0.69).
