Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
400 participants
OBSERVATIONAL
2017-06-09
2018-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Photoaged Male Subjects
45-80 year old males with visible photoaging and the desired exposure profile/driving history and who also has 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 is an multi-center trial, and study sites will range from northern to southern latitudes in North America, Australia and potentially other international sites. Study Photography + Personal \& Medical History Collection via a study questionnaire will be obtained.
Study Photography + Personal & Medical History Collection
3D facial images taken and complete a detailed study questionnaire
Photoaged Female Subjects
45-80 year old females with visible photoaging and the desired exposure profile/driving history and who also has 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 is an multi-center trial, and study sites will range from northern to southern latitudes in North America, Australia and potentially other international sites. Study Photography + Personal \& Medical History Collection via a study questionnaire will be obtained.
Study Photography + Personal & Medical History Collection
3D facial images taken and complete a detailed study questionnaire
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Study Photography + Personal & Medical History Collection
3D facial images taken and complete a detailed study questionnaire
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2\. Subjects must have spent, at minimum, an average of at least 30 minutes per day/ 5 days per week (as the driver) in an automobile for greater than or equal to 15 years of their adult life.
3\. Subjects must sign a written informed consent. 4. Subjects must agree to be photographed with the 3D camera system and sign a photo release.
5\. Subjects must agree to fill out the study questionnaire completely and to the best of their knowledge.
6\. Subjects must agree that the de-identified data and 3D images may be used for data mining to answer future study questions or assist in new investigations and discoveries.
Exclusion Criteria
2\. Concurrent therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study.
3\. Subjects who have had performed procedures which, in the study doctor's opinion, may interfere with the study data (for example: face lift, facial liposuction or facial volume fillers in the last 2 years) 4. Subjects whose primary automobile (used in the average drive estimate) has dark tinted window glass or UV filter applied to the driver's side window glass.
5\. Subjects who have spent a large portion of their lives at two very different latitude/locations (eg. Alternate 6 months of the year at a summer home in Maine and a winter home in Florida).
6\. Subjects who are unwilling or unable to comply with the requirements of the protocol.
7\. Subject has any disorder that may prevent compliance, such as history of chronic alcohol or drug abuse, significant mental or nervous disorder or other illness that would, in the evaluator's opinion, interfere with the study.
8\. Subjects with visible (or excessive vellus) facial hair (facial hair interferes with the 3D imaging capture and analysis).
9\. Subject's weight has ever been more than 30 lbs above or below current weight (does not include weight gain associated with pregnancy)
45 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allergan
INDUSTRY
Merz Aesthetics Inc.
INDUSTRY
ThermiGen, LLC
INDUSTRY
McDaniel Institute of Anti-Aging Research
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daivd H. McDaniel, MD
Role: STUDY_DIRECTOR
MIAAR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
McDaniel Institute of Anti-Aging Research
Virginia Beach, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Charmaine L Griffin
Role: primary
Chris Mazur
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FCLVOL-2017
Identifier Type: -
Identifier Source: org_study_id