Facial Asymmetrical Clinical Evaluation Study

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.

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)