An Open-Label Study Evaluating the Periorbital Skin Rejuvenation Efficacy of a Cosmeceutical Containing Methyl Estradiolpropanoate (MEP) in Women With Estrogen Deficient Skin (EDS)

Background: A cosmeceutical topical formulation containing a non-hormonal estrogen receptor activator, Methyl Estradiolpropanoate (MEP), has been developed to address periorbital skin aging in post-menopausal women with estrogen-deficient skin (EDS).Objective: The primary objective of the study was to evaluate the efficacy of Emepelle Eye Cream ® (Biopelle, Ferndale Pharma Group, Ferndale, MI, USA) for the rejuvenation of the periorbital skin areas in women EDS.The secondary objectives were to assess the tolerability and satisfaction with Emepelle Eye Cream as assessed by the clinical investigator and the participants.Methods: Clinical improvement (ie, change from baseline visit) to the end of study topical application in the periorbital areas were 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 self-evaluation of the quality of periorbital skin area questionnaire.Secondary objectives and endpoints were assessed using a subject Quality of Life (QoL) evaluation, a clinician-and a participant-evaluation of tolerability and side effects, and the C-GAIS and P-GAIS questionnaires.Baseline scores were compared to scores at the follow-up visits.Results: Clinician evaluations included a Global Aesthetic Improvement Scale (GAIS) rating of periorbital skin areas using a 6-point rating scale 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 averaged subject improvement results included improvements in each category at the primary endpoint.The subjects reported that their satisfaction with their periorbital appearance improved by 47% as compared to before treatment.The product was well tolerated by all subjects and no significant side effects were reported. Conclusion:In an open label study of 31 female subjects who had been amenorrheic for at least one year, topical application of Emepelle Eye Cream for periorbital skin rejuvenation was effective and well-tolerated.