A Study Evaluating Blended Belotero for the Treatment of Etched-in Fine Facial Lines

This is a study to evaluate the effects of Belotero blended with 0.1 cc of 1% lidocaine with
epinephrine per 1.0 cc of Belotero in the treatment of etched-in fine facial lines. 30
adults scheduled to have blended Belotero injected into fine lines of the cutaneous lip,
and/or radial cheek area, and/or nasolabial folds, and/or melolabial folds, and/or forehead
will be evaluated. The blended Belotero will be injected intradermally into these etched-in
fine lines. The patients will be given diary cards to document potential adverse events. 2
weeks after receiving injections of the blended Belotero the subjects will return to have
photographs taken, have their treated fine lines evaluated, and complete a self assessment
questionnaire. Touch-up injections are common clinical practice and if additional touch-ups
would improve their result, those subjects can be re-treated at this visit. Those subjects
who are touched up will return to the clinic for an additional follow up visit and
photographs 2 weeks later. All subjects will return to the clinic 12 weeks and 24 weeks
after their last injection for photographs and evaluations. Improvement assessments will be
made by investigator ratings at each visit. Investigator ratings for the cutaneous lip and
the forehead area are based on the Merz Aesthetic Validated Assessment Scales. Investigator
ratings for the radial cheek area, nasolabial folds, and melolabial folds are based on the
Validated Lemperle Facial Wrinkle Scales.

Inclusion Criteria:

- Adult females and males, aged 25-75 years.

- Subjects must be seeking treatment for etched-in fine lines of the cutaneous lip
area, and/or radial cheek area, and/or nasolabial fold area, and/or melolabial fold
area, and/or forehead area.

- Subjects must have one or more etched-in fine line on the cutaneous lip area, and/or
radial cheek area, and/or nasolabial fold area, and/or melolabial fold area, and/or
forehead area.

- Subjects must have been deemed eligible by the treating physician and be scheduled
for treatment of etched-in fine facial lines with Belotero blended with lidocaine
with epinephrine.

- Subjects must be willing to defer any other cosmetic procedures in the treatment area
while in the study. They can continue using topicals with retinoids, retinol, beta
hydroxy acids, or alpha hydroxyl acids if they were previously using these topicals
for at least 3 months prior to starting the study, but they should not initiate
cosmetic treatments with new topicals during the study period. They should not have
cosmetic treatments such as chemical peels, microdermabrasion, microneedling
procedures, laser procedures, botulinum toxin injections, or other injectable filler
therapy in the treatment area during the study period.

- Subjects must be willing and able to provide written informed consent in English

- Subjects must be willing and able to follow the procedures outlined in this protocol.

Exclusion Criteria:

- Subjects who are pregnant.

- Subjects with previous permanent injectable filler therapy to the treatment area.

- Subjects with previous non-permanent injectable filler therapy to the treatment area
within the past year.

- Subjects with previous botulinum toxin injections in the treatment area within the
past 6 months.

- Subjects with severe baseline facial lines in the treatment area with a score of 5
based on the Validated Lemperle Facial Wrinkle Scales.

- Subjects with visible scars in the treatment area that may affect evaluation of
response and/or quality of photography in the opinion of the investigator.

- Known allergy or sensitivity to any of the treatment injections or their components,
including or known or suspected lidocaine hypersensitivity.

- Subjects with an infection in the treatment area.

- Subjects are not to undergo any additional cosmetic procedures in the treatment area
during the study period.

- Subjects with a history of poor cooperation, non-compliance with medical treatment,
or unrealiability.