Subject Evaluation
Quality of the periorbital skin areas was rated by subjects through the completion of an 11-item questionnaire (Table 3). The averages of the self-evaluation ratings at baseline and at each follow-up visit for all participants who completed the study were calculated. The averaged improvement, which is the difference between the averaged self-evaluation rating score at baseline and the average score at each follow-up visit (week 4, week 8, week 12) expressed in percentages of the averaged baseline score, were calculated.
The averaged subject improvement results included improvements in each category at the primary endpoint. When expressing clinical results as averaged improvement for all subjects who completed the study, texture improved by 68%, under-eye fatigue by 50%, firmness or sagging by 48%, dark circles in the morning by 46%, moisture by 45%, fine lines by 44%, wrinkles by 43%, puffiness in the morning by 42%, dark circles in the evening by 40%, and transparency (visible appearance in skin thickness) by 34% (Figure 2). The subjects also reported that their satisfaction with their periorbital appearance improved by 47% as compared to before treatment. Additional subject evaluations included Global Aesthetic Improvement Scale (GAIS) using a 6-point scale (Table 2), subject-rated Quality of Life (QoL) questions, tolerability, and side effects. The averaged subject GAIS improvement for all subjects who completed the study improved by 22%. The mean subject GAIS score at study completion was 2.7, and 26 of the 31 subjects who completed the study showed improvement. A subject GAIS score of 1 (very much improved) was reported by four subjects.
All subjects who completed the trial liked the way the eye cream felt, and 85% said they would continue to use the eye cream on a regular basis. Furthermore, 73% of the subjects felt the eye cream alleviated some or all the periorbital skin issues they developed since entering menopause and would recommend the eye cream to other women undergoing menopause.
CONCLUSION
A 12-week clinical trial was completed by 31 postmenopausal women with estrogen-deficient skin in the periorbital area was conducted at 2 sites in the United States to examine the efficacy and tolerability of Emepelle Eye Cream, a topical formulation containing MEP, a synthetic estrogenic sterol ester. Clinician GAIS results showed improvement of the periorbital skin area in 84% of subjects who completed the study. The averaged clinical improvement by the clinician evaluation of the quality of periorbital skin showed improvement in all areas evaluated (color, texture, sagging, wrinkles) as early as week 4 and continued to improve through completion of the study. The averaged subject results included improvements in each category (moisture, look, texture, sagging, puffiness, color in the morning, color in the evening, skin thickness, fine lines, and wrinkles) at the primary
