Safety and Efficacy of Single Therapy Versus Double and Triple Therapy of the Pellevé™ Wrinkle Treatment System for the Treatment of Moderate Facial Wrinkles

NCT01299103 | Completed Results

• 1 other identifier: PEL-10-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study will enroll and treat a patients to assess improvement in the appearance of facial wrinkles.

Conditions

Appearance of Facial Wrinkles

Keywords

wrinkle; rhytide

Outcome Measures

Primary Outcomes (2)

• Fitzpatrick Wrinkle Assessment

  Subject photos will be evaluated using the 9-point Fitzpatrick Wrinkle Assessment Scale at all follow up visits. An improvement is noted by a decrease in the numeric Fitzpatrick Wrinkle score. The Fitzpatrick Wrinkle Assessment ranges from 1-9. Wrinkle Score between baseline and 90 days post treatment assessment. Positive values indicates an increase in score, while negative values indicate a decrease

  change in Fitzpatrick Wrinkle Score between baseline and 90 days post treatment assessment.

• Adverse Events

  The rate of adverse events occurring in treatment subjects will be assessed.

  90 days post treatment

Study Arms (3)

Single Treatment

ACTIVE COMPARATOR

Treatment of facial wrinkle with one treatment only

Device: Pelleve Wrinkle Treatment System

Double Treatment

ACTIVE COMPARATOR

Treatment of facial wrinkle with two treatments

Device: Pelleve Wrinkle Treatment System

Triple treatment

ACTIVE COMPARATOR

Treatment of facial wrinkle with three treatments

Device: Pelleve Wrinkle Treatment System

Interventions

Pelleve Wrinkle Treatment System DEVICE

comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System

Double Treatment; Single Treatment; Triple treatment

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females 35-60 years of age with Fitzpatrick Skin Color Type I-IV.
• Subjects with clinical evidence of facial wrinkles mild to moderate in severity as specified by a grade 4-6 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 facial rhytids in the 6 months preceding study enrollment through the duration of the study.
• Subjects who have had a prior cosmetic procedure to improve facial rhytids (i.e., rhytidectomy, periorbital or eyelid/eyebrow surgery, brow lift, 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.
• Ablative skin resurfacing on the glabellar area within the previous 6 months or during the study.
• Retinoid, 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.
• Any existing skin disease.
• 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.

Sponsors & Collaborators

• Ellman International: lead

Study Sites (1)

DeNova Research Institute

Chichago, Illinois, 60611, United States

Location

Results Point of Contact

• Title: Dr. Steven Dayan
• Organization: Chicago Center for Facial Plastic Surgery

sdayan@drdayan.com

(312) 335-2070

Study Officials

• Steven H. Dayan, MD

  DeNova Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 18, 2011
• Study Start: April 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 15, 2016
• Results First Posted: April 15, 2016

Record last verified: 2016-03

Locations

US (1)