Among these recent advances in skin-care development is Methyl Estradiolpropanoate (MEP), a synthetic estrogenic sterol ester with approximately 1% of the estrogen receptor binding affinity of estradiol. The Emepelle line of cosmeceutical skincare products contain not only proprietary MEP but also other ingredients that provide a multifactorial approach to treating skin aging and photoaging. In a recent study,4 the application of Emepelle Night Cream and Emepelle Day Serum were found to improve skin hydration, skin wrinkles, skin texture, and skin color. This current periorbital specific study further evaluates the Emepelle line of skin-care products in women with EDS— specifically women with signs of periorbital skin aging treated with Emepelle Eye Cream® (Biopelle Inc., Ferndale, MI). The study was conducted for Biopelle Inc. (Ferndale Pharma Group, Ferndale, MI) and approved by an independent institutional review board.
MATERIALS AND METHODS
This study was designed as an open-label, 2-center, 12-week clinical trial designed to evaluate a skin cream (Emepelle Eye Cream, Biopelle Inc., Ferndale, MI) formulated for skin rejuvenation in women with signs of EDS and intrinsic aging around the periorbital areas.
The primary objective endpoints were the clinical improvement (ie, change from baseline visit) to the end of study intervention in the periorbital areas as assessed by the clinical investigator (using the clinician-rated quality of periorbital skin area visual scoring scale) and by the participant (using the participant’s selfevaluation of the quality of periorbital skin area questionnaire). The improvements in EDS were also evaluated through photographic imaging obtained at baseline and at each followup visit. The secondary objectives of this study were to assess the tolerability and satisfaction with Emepelle Eye Cream as assessed by the clinical investigator and the participant. Secondary objectives and endpoints were assessed using a subject QoL evaluation, a clinician- and a participant-evaluation of tolerability and side effects, and C-GAIS and P-GAIS questionnaires. These instruments were to be completed at the baseline and compared to scores at the follow-up visits.
Study Population
The study enrolled females of non-childbearing potential who had a history of being amenorrheic for at least one (1) year and no more than 10 years, and at the same time had demonstrable fine or moderate wrinkles around both eyes and at least slightly visible dark areas, slightly coarse and grainy lower eyelids. Participants each agreed to refrain from using any other topical products on the periorbital skin or from undergoing any facial treatments during the 12-week study period. Participants agreed to avoid extended periods of sun exposure, including tanning beds, for the study period. When excessive sun exposure was unavoidable, participants agreed to wear appropriate protective clothing and to use the provided sunscreen.
Potential participants were excluded if they used any other semi-solid/prescription products on the periorbital areas, eye pads, or facial masks other than sunscreen products within one (1) month prior to the study participation; undergone any microdermabrasion, light or medium skin peel(s) within three (3) months prior to study participation; used any non-ablative laser, light or radiofrequency treatments within six (6) months prior to study participation; underwent any dermabrasion, deep skin peels, ablative laser treatments, botulinum toxin or filler injections on periorbital skin within 12 months prior to study participation; ever underwent blepharoplasty or cosmetic surgery affecting the periorbital skin, as well as those who were currently on hormone replacement therapy or who had been treated in the past year with hormone replacement therapy.
Upon the screening visit (day 14 to baseline), participants provided written informed consent and signed a Health Insurance Portability and Accountability Act (HIPAA) form. Medical history was reviewed including a review of current medications. Patients were advised of the potential adverse events associated with the study intervention including skin irritation, skin redness (erythema), edema (swelling due to the buildup of fluids), dryness or scaling skin, itchiness/pruritis, burning/stinging, and skin tenderness. Participants signed the consent document, their medical and surgical history was reviewed. Each participant was assessed by the study physician for fine lines/wrinkles around their eye area, the presence of dark areas around the eyes and the skin texture around the eyes and eyelids.
Study Intervention
Enrolled participants were instructed on how to treat their skin during the study intervention period, specifically to only use the skin care products provided by the study investigator. They were instructed to wash their face twice daily with a gentle cleanser (eg, Cerave) prior to applying the study intervention.
Participants were supplied with a 15 gm bottle with pump containing Emepelle Eye Cream at the baseline visit and given a daily diary to record the date and the time of their twice daily (ie, morning and evening) application. Participants were instructed to gently apply a pea-sized amount of the eye cream to both periorbital eye areas each morning of the study period immediately after washing/cleansing and drying the face. Participants were also instructed to apply the provided facial sunscreen (EltaMD UV Clear, SPF 30 or higher) approximately 15 minutes after applying the eye cream. Participants who were in direct sunlight or had significant window exposure (eg, driving car, work by window, or under skylights) were instructed to diligently reapply the facial sunscreen every 2 hours throughout the day.
Primary Efficacy Assessments
The quality of the periorbital skin areas assessed by the clinician
The primary objective endpoints were the clinical improvement (ie, change from baseline visit) to the end of study intervention in the periorbital areas as assessed by the clinical investigator (using the clinician-rated quality of periorbital skin area visual scoring scale) and by the participant (using the participant’s selfevaluation of the quality of periorbital skin area questionnaire). The improvements in EDS were also evaluated through photographic imaging obtained at baseline and at each followup visit. The secondary objectives of this study were to assess the tolerability and satisfaction with Emepelle Eye Cream as assessed by the clinical investigator and the participant. Secondary objectives and endpoints were assessed using a subject QoL evaluation, a clinician- and a participant-evaluation of tolerability and side effects, and C-GAIS and P-GAIS questionnaires. These instruments were to be completed at the baseline and compared to scores at the follow-up visits.
Study Population
The study enrolled females of non-childbearing potential who had a history of being amenorrheic for at least one (1) year and no more than 10 years, and at the same time had demonstrable fine or moderate wrinkles around both eyes and at least slightly visible dark areas, slightly coarse and grainy lower eyelids. Participants each agreed to refrain from using any other topical products on the periorbital skin or from undergoing any facial treatments during the 12-week study period. Participants agreed to avoid extended periods of sun exposure, including tanning beds, for the study period. When excessive sun exposure was unavoidable, participants agreed to wear appropriate protective clothing and to use the provided sunscreen.
Potential participants were excluded if they used any other semi-solid/prescription products on the periorbital areas, eye pads, or facial masks other than sunscreen products within one (1) month prior to the study participation; undergone any microdermabrasion, light or medium skin peel(s) within three (3) months prior to study participation; used any non-ablative laser, light or radiofrequency treatments within six (6) months prior to study participation; underwent any dermabrasion, deep skin peels, ablative laser treatments, botulinum toxin or filler injections on periorbital skin within 12 months prior to study participation; ever underwent blepharoplasty or cosmetic surgery affecting the periorbital skin, as well as those who were currently on hormone replacement therapy or who had been treated in the past year with hormone replacement therapy.
Upon the screening visit (day 14 to baseline), participants provided written informed consent and signed a Health Insurance Portability and Accountability Act (HIPAA) form. Medical history was reviewed including a review of current medications. Patients were advised of the potential adverse events associated with the study intervention including skin irritation, skin redness (erythema), edema (swelling due to the buildup of fluids), dryness or scaling skin, itchiness/pruritis, burning/stinging, and skin tenderness. Participants signed the consent document, their medical and surgical history was reviewed. Each participant was assessed by the study physician for fine lines/wrinkles around their eye area, the presence of dark areas around the eyes and the skin texture around the eyes and eyelids.
Study Intervention
Enrolled participants were instructed on how to treat their skin during the study intervention period, specifically to only use the skin care products provided by the study investigator. They were instructed to wash their face twice daily with a gentle cleanser (eg, Cerave) prior to applying the study intervention.
Participants were supplied with a 15 gm bottle with pump containing Emepelle Eye Cream at the baseline visit and given a daily diary to record the date and the time of their twice daily (ie, morning and evening) application. Participants were instructed to gently apply a pea-sized amount of the eye cream to both periorbital eye areas each morning of the study period immediately after washing/cleansing and drying the face. Participants were also instructed to apply the provided facial sunscreen (EltaMD UV Clear, SPF 30 or higher) approximately 15 minutes after applying the eye cream. Participants who were in direct sunlight or had significant window exposure (eg, driving car, work by window, or under skylights) were instructed to diligently reapply the facial sunscreen every 2 hours throughout the day.
Primary Efficacy Assessments
The quality of the periorbital skin areas assessed by the clinician
