and by the participant were the primary efficacy assessments. The quality of the periorbital skin areas was assessed at baseline and at each follow-up visit (ie, week 4, week 8, and week 12). The primary endpoint of the clinician-scored and participant-rated periorbital skin quality assessments were the changes from baseline (day 1) to after the study intervention period. These assessments of skin quality were also established through review of the photographic/3D images obtained at baseline and at each follow-up visit.
At baseline and at each follow-up visit, the quality of the periorbital skin areas was evaluated by the clinical investigator using a 4- to 5-point visual scoring system that assesses skin color, texture, sagging, and wrinkles.
The averages of the clinician quality score of the periorbital skin areas at baseline and at each follow-up visit for participants who completed the study was calculated. The average improvement, which was the difference between the average score before and the average score after treatment expressed in percentages of the averaged baseline score, was calculated.
At baseline and at each follow-up visit, the quality of the periorbital skin areas was rated by the participants through their completion of an 11-item questionnaire.
The averages of the self-evaluation ratings at baseline and at follow-up visits for all participants who completed the study (74% completed) was then calculated. The averaged improvement, which was the difference between the averaged self-evaluation rating score at baseline and the averaged score at each follow-up visit expressed in percentages of the averaged baseline score, was calculated.
Secondary Efficacy and Tolerability Assessments
The secondary assessment parameters included clinicianand participant-rated evaluations such as a QoL evaluation (participants only), evaluations of tolerability and side effects, and completion of the Global Aesthetic Improvement Scale questionnaires. These instruments were completed at the baseline visit and at each follow-up visit.
At the baseline visit, the participant rated their level of "worry" and how "unhappy" they were about the quality of their periorbital skin areas since entering menopause. At the followup visits (ie, week 4, week 8, and week 12), participants rated questions related to periorbital skin changes and satisfaction with the study intervention (ie, Emepelle Eye Cream).
The baseline ratings and progress questions were answered using the following choices: Extremely, Very, Somewhat, or Not at All.
At each follow-up visit, the clinician and the participant completed the GAIS questionnaires. In these, they are asked to rate on a 1 to 6 scale their impression of their periorbital skin areas. Score ratings and description were as follows: 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; and 6 = much worse.
At each follow-up visit, the clinician and the participant rated characteristics of local tolerability of the study intervention on the periorbital skin areas using a four (4)-point scale. Any adverse event(s) experienced by the participant during the study intervention period, whether related to the treatment or not, were recorded in the "Case Report Form".
At baseline and at each follow-up visit, the quality of the periorbital skin areas was evaluated by the clinical investigator using a 4- to 5-point visual scoring system that assesses skin color, texture, sagging, and wrinkles.
The averages of the clinician quality score of the periorbital skin areas at baseline and at each follow-up visit for participants who completed the study was calculated. The average improvement, which was the difference between the average score before and the average score after treatment expressed in percentages of the averaged baseline score, was calculated.
At baseline and at each follow-up visit, the quality of the periorbital skin areas was rated by the participants through their completion of an 11-item questionnaire.
The averages of the self-evaluation ratings at baseline and at follow-up visits for all participants who completed the study (74% completed) was then calculated. The averaged improvement, which was the difference between the averaged self-evaluation rating score at baseline and the averaged score at each follow-up visit expressed in percentages of the averaged baseline score, was calculated.
Secondary Efficacy and Tolerability Assessments
The secondary assessment parameters included clinicianand participant-rated evaluations such as a QoL evaluation (participants only), evaluations of tolerability and side effects, and completion of the Global Aesthetic Improvement Scale questionnaires. These instruments were completed at the baseline visit and at each follow-up visit.
At the baseline visit, the participant rated their level of "worry" and how "unhappy" they were about the quality of their periorbital skin areas since entering menopause. At the followup visits (ie, week 4, week 8, and week 12), participants rated questions related to periorbital skin changes and satisfaction with the study intervention (ie, Emepelle Eye Cream).
The baseline ratings and progress questions were answered using the following choices: Extremely, Very, Somewhat, or Not at All.
At each follow-up visit, the clinician and the participant completed the GAIS questionnaires. In these, they are asked to rate on a 1 to 6 scale their impression of their periorbital skin areas. Score ratings and description were as follows: 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; and 6 = much worse.
At each follow-up visit, the clinician and the participant rated characteristics of local tolerability of the study intervention on the periorbital skin areas using a four (4)-point scale. Any adverse event(s) experienced by the participant during the study intervention period, whether related to the treatment or not, were recorded in the "Case Report Form".
RESULTS
Thirty-one female subjects, amenorrheic for at least one year, averaged 57 years of age (between 50 to 65 years) completed the study. Of the 42 subjects enrolled, one elected to withdraw from the study (no reason given), 5 were lost to follow up, 2 missed one follow up appointment, and 3 had incomplete evaluation data. Subjects ranged from II to VI on the Fitzpatrick Scale: Fitzpatrick II, 26%; Fitzpatrick III, 55%; Fitzpatrick IV, 12%; Fitzpatrick V, 5%; and Fitzpatrick VI, 2%.
