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

March 28, 2016 updated by: Ellman International

A Prospective, Randomized, Open-Label, 3-Arm Parallel Study Comparing the Safety and Efficacy of Single Therapy Versus Double and Triple Therapy Using the Surgitron® Dual RF™ S5 With the Pellevé™ Wrinkle Treatment Handpiece and Pellevé™ Treatment Gel for the Treatment of Moderate Facial Wrinkles in Fitzpatrick Skin Types I - IV

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will enroll and treat a total of 44 subjects (23 in treatment Group A receiving a single treatment and 21 in treatment Group B receiving two treatments) with moderate facial wrinkles corresponding to a grade of 4-6 on the validated Fitzpatrick Wrinkle Assessment Scale.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chichago, Illinois, United States, 60611
        • DeNova Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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 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 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.
  • 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, non¬compliance with medical treatment or unreliability.
  • Enrollment in any active study involving the use of investigational devices or drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Single Treatment
Treatment of facial wrinkle with one treatment only
Device: Pelleve Wrinkle Treatment System
comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
ACTIVE_COMPARATOR: Double Treatment
Treatment of facial wrinkle with two treatments
Device: Pelleve Wrinkle Treatment System
comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
ACTIVE_COMPARATOR: Triple treatment
Treatment of facial wrinkle with three treatments
Device: Pelleve Wrinkle Treatment System
comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fitzpatrick Wrinkle Assessment
Time Frame: change in Fitzpatrick Wrinkle Score between baseline and 90 days post treatment 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
Time Frame: 90 days post treatment
The rate of adverse events occurring in treatment subjects will be assessed.
90 days post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ellman International

Investigators

  • Principal Investigator: Steven H. Dayan, MD, DeNova Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

February 4, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (ESTIMATE)

February 18, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 15, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEL-10-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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