Facial Asymmetrical Clinical Evaluation Study

Status unconfirmed

Conditions studied: Loss of Facial Adipose Tissue

In brief

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

Key facts

Study ID: NCT03347747
Run by: McDaniel Institute of Anti-Aging Research
People needed: 400
Starts: 2017-06-09
Expected to finish: 2018-07-31
Last updated by the study team: 2017-11-20

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.
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.
Subjects must sign a written informed consent. 4. Subjects must agree to be photographed with the 3D camera system and sign a photo release.
Subjects must agree to fill out the study questionnaire completely and to the best of their knowledge.
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.

You may not qualify if…

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.
Concurrent therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study.
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.
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).
Subjects who are unwilling or unable to comply with the requirements of the protocol.
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.
Subjects with visible (or excessive vellus) facial hair (facial hair interferes with the 3D imaging capture and analysis).
Subject's weight has ever been more than 30 lbs above or below current weight (does not include weight gain associated with pregnancy)

Where it is running

McDaniel Institute of Anti-Aging Research — Virginia Beach, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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