At week 8, 93% of patients felt that they were “more comfort- able” with the appearance of their skin compared to baseline and 50% or more of the participants reported improvement in wrinkles, thickness, integrity, dullness, texture, and color. Also, at week 8, on the 0 to 5 Facial Skin Hydration Scale, 100% of study participants documented at least one grade improvement and 64% verified two grades or more improvement.
By week 8, subjects showed a 34% improvement in texture on the Alexiades‐Armenakas Comprehensive Grading Scale for Assessment of Skin Aging and Photodamage. On the Subject Questionnaire on Quality of Life, 93% said their skin felt “more comfortable” post application of the topical products, that their skin “looked better”.
On a 0-5 Facial Skin Hydration Scale, 100% of study participants showed at least 1-step improvement and 8 of 14 (57%) saw a 2-grade or more improvement in hydration. 100% of study participants showed aesthetic improvements per Investigator Global Aesthetic Improvement Scale (GAIS) at week 14.
Baseline to Week 20
By week 20, 93% of study participants responded that Emepelle helped improve the appearance of wrinkles, texture, and color.
Also, by week 20, 86% of study participants responded that Emepelle helped improve the appearance of sun damage, thick- ness, and integrity. In the Subject Questionnaire on Quality of Life, 86% of study participants responded that Emepelle helped alleviate some or all of the skin issues they have developed since entering menopause by week 20.
Overall, from baseline to end of study at 20 weeks, patients showed a 53% improvement in texture, 21% improvement in keratoses, and 15% improvement in laxity on the Alexiades-Ar- menakas Quantitative and Comprehensive Grading Scale.
More notable improvements were made in terms of appearance of the skin and menopausal-related skin issues throughout the course of the study. For example, at 8 weeks, 21% of patients reported 'very' or 'extremely' to the question "Do you feel the application of the study topical products made your skin look better" vs 64% after 20 weeks.
Furthermore, at 8 weeks, 7% of patients reported 'very' or 'extremely' to the question "Do you feel the study products have helped alleviate some or all of the skin issues you have devel- oped since entering menopause" compared to 64% at 20 weeks.
Studies have shown that estrogen attenuation/diminution in postmenopausal conditions accelerates many skin changes, including dryness, atrophy, fine wrinkling, and poor wound healing.15 Thus, the effects of low estrogen on the skin are an important endogenous cause of aging skin in women; yet, topical strategies that target estrogen deficiency are limited.16
In this open-label experience trial, all patients expressed satisfaction with the formulations of Emepelle Serum and Night Cream. Patients on the younger end of the study spectrum (53- 60 years) seemed to show significant improvement in about 8 weeks (See Figures 1 and 2).
In older patients (over 63 years) who presumably have been in menopause longer, significant improvement seemed to take longer, but was shown by 20 weeks (See Figures 3 and 4).
Since a subset of older trial participants took longer for their roughness and dryness to improve, it may take time to rebuild