Loss of Facial Adipose Tissue Clinical Trial
— FACEOfficial title:
Asymmetrical Facial Volume Loss From Disproportionate Light Exposure: A Clinical Validation Study
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
| Status | Recruiting |
| Enrollment | 400 |
| Est. completion date | July 31, 2018 |
| Est. primary completion date | June 30, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 45 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Subjects must be 45 to 80 years of age with no known medical conditions that, in the investigator's opinion, may interfere with study participation. 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: - Any dermatologic disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's facial skin. Examples of such disorders include severe acne vulgaris, acne conglobata, acne fulminans, facial seborrheic dermatitis, and lupus erythematosus. 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | McDaniel Institute of Anti-Aging Research | Virginia Beach | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| McDaniel Institute of Anti-Aging Research | Allergan, Merz Aesthetics Inc., ThermiGen, LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Study Photos and Questionnaire Data Processing | The questionnaire data will be entered into a central spreadsheet for future analysis. The images will be uploaded directly to Canfield Scientific for image review and analyzed using software based on a "best fit" algorithm designed using 1000 facial images to determine any volume differences between the right and left sides of the face. Statistical significance will be generated for the data and applied to the general population of 300,000,000 with a 95% confidence interval (based on a study population of 400 subjects). Detailed statistics may be performed utilized using an online statistics calculator as required. The full complement of images and data from each site, will be returned to the McDaniel Institute of Anti-Aging Research. | June 2018 |