Clinical Evaluation
Quality of periorbital skin area was assessed in each subject by a clinical investigator using a 4- to 5-point visual scoring system (Table 1). The averages of the clinical score before (baseline) and at each follow-up visit (week 4, week 8, and week 12) for all the subjects who completed the study were calculated. The averaged clinical improvement, which was the difference between the averaged clinical score before and the averaged clinical score at the primary endpoint (week 12) expressed in percentages of the averaged baseline score, was then calculated.
The averaged clinical-improvement results included improvements in each category. When expressing clinical results as averaged improvement for all subjects who completed the study, firmness or sagging improved by 49%, texture by 47%, dark circles by 44%, and periorbital wrinkles by 44%. Additionally, clinical improvement was seen at the first follow up appointment (week 4) in which texture improved by 24%, dark circles by 23%, firmness or sagging by 23%, and periorbital wrinkles by 17%, as shown in Figure 1.
Additional clinician evaluations included a Global Aesthetic Improvement Scale (GAIS) rating of periorbital skin areas using a 6-point scale (Table 2) as well as tolerability and side effects. The averaged clinical GAIS improvement for all subjects who completed the study improved by 21%. The mean clinician GAIS score at study completion was 2.7, and 26 of the 31 subjects who completed the study showed improvement. A clinician GAIS score of 1 (very much improved) was observed in 3 study subjects. The product was well tolerated by all subjects and no significant side effects were reported.
