Prospective Pellevé™ Neck Wrinkle Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ellman International
ClinicalTrials.gov Identifier:
NCT01299090
First received: February 4, 2011
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Facial and Neck Rhytides
Device: Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Pellevé™ Neck Wrinkle Study

Further study details as provided by Ellman International:

Primary Outcome Measures:
  • Change in Neck and Facial Wrinkles using the Fitzpatrick Wrinkle Assessment [ Time Frame: 90 days post treatment ] [ Designated as safety issue: No ]
    Three independent investigators blinded to photography time points will perform retrospective evaluations of photography from all visits using the 9-point Fitzpatrick Wrinkle Assessment Scale for assessment of neck and facial wrinkles at the culmination of the study.

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 90 days post treatment ] [ Designated as safety issue: Yes ]
    The rate of adverse events will be assessed throughout the duration of the study


Enrollment: 50
Study Start Date: November 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group
All subjects enrolled were in the treatment group.
Device: Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator
two treatments spaced 30 days apart

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299090

Locations
United States, California
Moy-Fincher-Chipps Facial Plastics/Dermatology
Beverly Hills, California, United States, 90210
Sponsors and Collaborators
Ellman International
Investigators
Principal Investigator: Lisa Chipps, MD Moy-Fincher-Chipps Facial Plastics/Dermatology
  More Information

No publications provided

Responsible Party: Ellman International
ClinicalTrials.gov Identifier: NCT01299090     History of Changes
Other Study ID Numbers: PEL-09-02
Study First Received: February 4, 2011
Last Updated: February 25, 2013
Health Authority: United States: Independent Review Board

Keywords provided by Ellman International:
wrinkles
rhytides

ClinicalTrials.gov processed this record on August 20, 2014