Status:
UNKNOWN
Facial Asymmetrical Clinical Evaluation Study
Lead Sponsor:
McDaniel Institute of Anti-Aging Research
Collaborating Sponsors:
Allergan
Merz Aesthetics Inc.
Conditions:
Loss of Facial Adipose Tissue
Eligibility:
All Genders
45-80 years
Brief Summary
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 ca...
Detailed Description
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 occ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 9 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2018
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03347747
Start Date
June 9 2017
End Date
July 31 2018
Last Update
November 20 2017
Active Locations (1)
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1
McDaniel Institute of Anti-Aging Research
Virginia Beach, Virginia, United States, 23462