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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ellman International
ClinicalTrials.gov Identifier:
NCT01299103
First received: February 4, 2011
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

This study compares the safety and efficacy of single therapy versus double therapy using the Pellevé™ Wrinkle Treatment System for the treatment of mild to moderate facial wrinkles in Fitzpatrick Skin Types I - IV. Safety is assessed by analysis of adverse events. Efficacy is assessed by change in Fitzpatrick score for facial wrinkles.


Condition Intervention
Facial Rhytides
Device: Pelleve Wrinkle Treatment System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Ellman International:

Primary Outcome Measures:
  • Fitzpatrick Wrinkle Assessment [ Time Frame: 90 days post treatment ] [ Designated as safety issue: No ]
    Subject photos will be evaluated using the 9-point Fitzpatrick Wrinkle Assessment Scale at all follow up visits.

  • Adverse Events [ Time Frame: 90 days post treatment ] [ Designated as safety issue: Yes ]
    The rate of adverse events occurring in treatment subjects will be assessed.


Secondary Outcome Measures:
  • Blinded Fitzpatrick Assessment [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Three physicians blinded to study timepoints will score standardized photography for facial wrinkles using the Fitzpatrick Scale.


Enrollment: 54
Study Start Date: April 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single Treatment Device: Pelleve Wrinkle Treatment System
comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
Active Comparator: Double Treatment Device: Pelleve Wrinkle Treatment System
comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
Active Comparator: Triple Treatment Device: Pelleve Wrinkle Treatment System
comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01299103

Locations
United States, Illinois
DeNova Research Institute
Chichago, Illinois, United States, 60611
Sponsors and Collaborators
Ellman International
Investigators
Principal Investigator: Steven H. Dayan, MD DeNova Research
  More Information

No publications provided

Responsible Party: Ellman International
ClinicalTrials.gov Identifier: NCT01299103     History of Changes
Other Study ID Numbers: PEL-10-02
Study First Received: February 4, 2011
Last Updated: April 18, 2012
Health Authority: United States: Independent Review Board

Keywords provided by Ellman International:
wrinkle
rhytide

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014