Prospective Pellevé™ Neck Wrinkle Study
Prospective Pellevé™ Neck Wrinkle Study
Use of RF device to treat wrinkles of the neck
This is a prospective study evaluating the safety and efficacy of two treatments, spaced at
 30 day intervals, using the Surgitron® Dual RF™ S5 with the Pellevé™ wrinkle treatment
 handpiece and Pellevé™ treatment gel for the treatment of neck wrinkles.
Inclusion Criteria:

 -  30-70 years of age

 -  Subjects with clinical evidence of neck wrinkles moderate to severe in severity as
 specified by a grade 4-9 on the Fitzpatrick Wrinkle Assessment Scale.

 -  Willingness and ability to comply with protocol requirements, including returning for
 follow-up visits and abstaining from exclusionary procedures for the duration of the
 study.

 -  Willingness and ability to provide written photo consent and adherence to photography
 procedures(i.e., removal of jewelry and makeup).

 -  Willingness and ability to provide written informed consent prior to performance of
 any study related procedure.

 Exclusion Criteria:

 -  Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a
 reliable form of birth control.

 -  Subjects who have had prior exposure to any hyaluronic acid, or any other filler,
 injection for any purpose in the 12 months preceding study enrollment through the
 duration of the study.

 -  Subjects who have had prior exposure to any botulinum toxin for rhytids in the
 treatment area in the 6 months preceding study enrollment through the duration of the
 study.

 -  Subjects who have had a prior cosmetic procedure to improve rhytids in the treatment
 area (i.e.,rhytidectomy, CO2/erbium laser resurfacing, Thermage/Thermacool
 radiofrequency treatment)within 12 months or who have visible scars that may affect
 evaluation of response and/or quality of photography.

 -  Microdermabrasion, or prescription level glycolic acid treatments within 3 months
 prior to study participation or during the study.

 -  Active cut, wound, or infection on the skin.

 -  Oral Isotretinon within the past 12 months.

 -  Active HSV-1.

 -  History of keloids or hypertrophic scarring.

 -  Existing or history of skin malignancy in the treatment area during the past 12
 months.

 -  Existing or history of skin disease in the treatment area during the past 12 months.

 -  History of collagen or vascular disease.

 -  Subjects who have implantable pacemaker, automatic implantable defibrillator/
 cadioversor (AICD), or any other implantable electric device.

 -  Subjects who have used, within 30 days, any medication that can cause dermal
 hypersensitivity or affect skin characteristics.

 -  History of autoimmune disease.

 -  History of any disease that inhibits pain sensation.

 -  History of Diabetes I or II.

 -  Concurrent therapy that, in the investigator's opinion, would interfere with the
 evaluation of the safety or efficacy of the study medication.

 -  Subjects who anticipate the need for surgery or overnight hospitalization during the
 study.

 -  Subjects who, in the Investigator's opinion, have a history of poor cooperation,
 noncompliance with medical treatment or unreliability.

 -  Enrollment in any active study involving the use of investigational devices or drugs.