Facial Asymmetrical Clinical Evaluation Study

Overview

The primary objective of this study is to create digital 3D images of subjects using a Canfield VECTRA H1 digital imaging system and compile a medical, skin/sun exposure and sunscreen use, and skin care product history for a large number of subjects. This data will allow for image and statistical analysis to determine if facial volume loss is greater on one side, and what factors may be causing this. The data collected will also serve as a database for future lines of inquiry relating to data collected in this study. Your data (including 3D images) will be kept in this database and may be accessed in the future by any Sponsor or Investigator. Your data will be de-identified and your name will not be associated with the questionnaire responses

It has been long noted that facial volume loss is one of the primary visible components of aging. Asymmetrical volume loss has been noted as well, but there is no proven theory explaining why this occurs. This study will attempt to determine whether there is an association between greater facial volume loss on the drivers' window side of the face. This data will allow for image and statistical analysis to determine if a facial volume loss differential exists, and what factors may be isolated to determine causality The study population will be between 350-500 males or females aged 45-80 having visible photodamage and spent (or are spending) at least 30 minutes in a car per day (as the driver), 5 days per week for at least 15 years of their adult life to ensure they have the type of asymmetrical exposure required for hypothesis validation. This will be a multi-center trial, and study sites will range from northern to southern latitudes in North America, Australia and potentially other international sites. This study is to be conducted under the general supervision of PI(s) and will follow the general guidelines recommended in current Good Clinical Practices (cGCP). Individual sites will have a PI to supervise study related procedures and data collection and will be in contact with Dr. McDaniel and staff throughout the study. The study period for each subject will be approximately 1-2 visits. Consented and qualified subjects will be imaged using the Canfield VECTRA H1 digital imaging system as described above and then given the study questionnaire and completion instructions. Once the subject has had both the images and questionnaire reviewed by study personnel for completeness, their participation in this study is ended; unless the supplemental contact visit is determined to be required for data clarification or additional, IRB approved, follow up questions.