Vollure for the Correction of Atrophic Facial Scarring
Vollure for the Correction of Atrophic Facial Scarring
Subjects will be randomized to receive up to 1cc of Juvéderm Vollure on one side of their
 face and up to 1cc of Saline on the other. On Day 30, this treatment with the same left-right
 assignment can be repeated. Subjects will return 24-48 hours after their first treatment to
 fill out questionnaires, take pictures, and to be assessed by blinded evaluators regarding
 short term adverse events. Subjects will fill out a 30 day subject diary and also return 30
 and 90 days after their last treatment to fill out questionnaires, take pictures, complete
 the Global Aesthetic Improvement Scale (GAIS), and to be assessed on the QGSGS and for
 long-term adverse events by blinded evaluators. At 12 months, 18 months, and 24 months, the
 subjects will return to fill out questionnaires, take pictures, and to be assessed by blinded
 evaluators for long-term efficacy.
Subjects with grades ranging from 4-55 on the Quantitative Global Scarring Grading System
 (QGSGS)1 will be randomized to receive up to 1cc of Juvéderm Vollure on one side of their
 face and up to 1cc of Saline on the other. On Day 30, this treatment with the same left-right
 assignment can be repeated if optimal correction on the active intervention side has not been
 achieved according to the treating investigator. Subjects will return 24-48 hours after their
 first treatment to fill out questionnaires, take pictures, and to be assessed by blinded
 evaluators regarding short term adverse events. Subjects will fill out a 30 day subject diary
 and also return 30 and 90 days after their last treatment to fill out questionnaires, take
 pictures, complete the Global Aesthetic Improvement Scale (GAIS), and to be assessed on the
 QGSGS and for long-term adverse events by blinded evaluators. The subjects will be eligible
 to receive treatment with Juvéderm Vollure 90 days after their last treatment on the
 placebo-controlled side if they choose. In addition, at 12 months, 18 months, and 24 months,
 the subjects will return to fill out questionnaires, take pictures, and to be assessed by
 blinded evaluators for long-term efficacy.
Inclusion Criteria:

 -  In good general health as evidenced by medical history

 -  For females of reproductive potential: use of highly effective contraception and a
 negative urine pregnancy test at screening and all injection visits.

 -  Score of 4-55 on a validated scarring grading system

 Exclusion Criteria:

 -  Subjects with allergies to hyaluronic acid filler, gram positive bacteria or
 lidocaine.

 -  Subjects with auto-immune conditions

 -  Subjects with diabetes

 -  Subjects with a history of sever anaphylactic reactions

 -  Subjects with cancer, or other life-threatening medical condition

 -  Subjects taking anti---coagulants, chemotherapy, immunosuppressive agents,
 immunomodulatory agents, diuretics, anti---histamines, or anti---inflammatory
 medications in the 2 weeks prior to the study or who will need to take these
 medications at any time during the first 120 days of the study.

 -  Subjects with any scheduled laser, light, or surgical procedures during the study,
 including dental surgery.

 -  Subjects who had neuromodulators in the past 6 months or hyaluronic acid fillers in
 the previous year on the face

 -  Subjects who at any time had surgery or more permanent fillers in the face such as
 Bellafill or Radiesse

 -  Subjects with tattoos or many skin growths on the face that would obscure
 visualization of the scars

 -  Subjects with a history of keloid or hypertrophic scar on the face

 -  Subjects unwilling or unable to sit still while an injector places Juvéderm Vollure in
 the face

 -  Subjects unwilling or unable to keep their head still during the photos

 -  Subjects who are pregnant or nursing

 -  Female subjects of child-bearing potential unable to take or use some form of birth
 control

 -  Subjects with any facial bruising or swelling

 -  Subjects with current skin infections, tumors, herpes outbreak or dermatitis on the
 face

 -  Subjects using skin-irritating topical preparations, pigmenting agents (self-tanning
 or bleaching creams), in the past two weeks or for the first 120 days of the study on
 the face

 -  Any medical condition that in the opinion of the Investigator would make the subject
 unsuitable for inclusion

 -  Women who are pregnant or breast feeding, or women of childbearing potential who are
 not practicing adequate contraception or planning to become pregnant during the study
 period.

 -  Study site personnel, close relatives of the study site personnel (e.g. parents,
 children, siblings, or spouse), employees, or close relatives of employee.