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

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ClinicalTrials.gov Identifier: NCT01299103
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : April 15, 2016
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Ellman International

Study Description
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Brief Summary:
The study will enroll and treat a patients to assess improvement in the appearance of facial wrinkles.

Condition or disease Intervention/treatment Phase
Appearance of Facial Wrinkles Device: Pelleve Wrinkle Treatment System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : April 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Adverse Events [ Time Frame: 90 days post treatment ]
    The rate of adverse events occurring in treatment subjects will be assessed.


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299103


Locations
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United States, Illinois
DeNova Research Institute
Chichago, Illinois, United States, 60611
Sponsors and Collaborators
Ellman International
Investigators
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Principal Investigator: Steven H. Dayan, MD DeNova Research
More Information
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Responsible Party: Ellman International
ClinicalTrials.gov Identifier: NCT01299103    
Other Study ID Numbers: PEL-10-02
First Posted: February 18, 2011    Key Record Dates
Results First Posted: April 15, 2016
Last Update Posted: April 15, 2016
Last Verified: March 2016
Keywords provided by Ellman International:
wrinkle
rhytide
Additional relevant MeSH terms:
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Facies
Disease Attributes
Pathologic Processes