Prospective Pellevé™ Neck Wrinkle Study

NCT01299090 | Completed Results

• 1 other identifier: PEL-09-02
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Use of RF device to treat wrinkles of the neck

Conditions

Facial and Neck Rhytides

Keywords

wrinkles; rhytides

Outcome Measures

Primary Outcomes (2)

• Change in Neck and Facial Wrinkles Using the Fitzpatrick Wrinkle Assessment

  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. The measurement is for percentage of patients who showed improvement

  90 days post treatment

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  The rate of adverse events will be assessed throughout the duration of the study

  90 days post treatment

Study Arms (1)

Treatment Group

EXPERIMENTAL

All subjects enrolled were in the treatment group.

Device: Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator

Interventions

Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator DEVICE

two treatments spaced 30 days apart

Treatment Group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ellman International: lead

Study Sites (1)

Moy-Fincher-Chipps Facial Plastics/Dermatology

Beverly Hills, California, 90210, United States

Location

MeSH Terms

Conditions

Facies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Lisa Chipps, MD
• Organization: Moy, Fincher, Chipps Medical Group

lchipps@ucla.com

(310) 274-5372

Study Officials

• Lisa Chipps, MD

  Moy-Fincher-Chipps Facial Plastics/Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 18, 2011
• Study Start: November 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 27, 2016
• Results First Posted: November 21, 2014

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)