Performance of the ePrime System for Cellulite

Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of Cellulite

Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of Cellulite.

Study Overview

• Status: Unknown
• Conditions: Cellulite
• Intervention / Treatment: Device: ePrime

Detailed Description

Up to 60 healthy adult volunteers seeking cellulite treatment, females of 25 to 60 years of age, from multiple investigational sites.

This is an open-label, multi-center study. Subjects in this study will receive a single subcutaneous treatment with the ePrime device in one treatment session according to the study protocol.

Prior to treatments, tissue to be treated will be injected with tumescence or local dermal infiltration solution according to the protocol. Subjects will return for follow-up (FU) visits at: 1 week, 1 month, 3 months and 6 months following the treatment.

Methodology described in protocol to evaluate efficacy of treatments will be carried out at each visit.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33133
      • Bowes Leyda
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • David Goldberg
  • New York
    • New York, New York, United States, 10028
      • Macrene Alexiades
  • North Carolina
    • Charlotte, North Carolina, United States, 28270
      • Girish Munavalli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Subjects seeking treatment of cellulite in the upper thighs and buttocks areas.
2. Subject have cellulite stage II or III as graded using Nurnberger-Muller scale clasification (Appendix III)
3. Healthy female subjects ages 25 to 60 years of age
4. Informed consent process completed and subject signed consent
5. Willing to receive the proposed ePrime treatment and follow-up protocol
6. Not pregnant or lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence)
7. Willing to have photographs taken of the treated areas to be used de-identified in evaluations, publications and presentations

Exclusion Criteria:

1. Subject had surgery or any other procedure for cellulite in the last 6 months
2. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
3. Known allergy to lidocaine or epinephrine or antibiotics
4. Active malignancy or history of malignancy in the past 5 years
5. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
6. Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the Physician would interfere with the anesthesia, treatment, or healing process)
7. Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion)
8. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
9. Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen
10. History of significant lymphatic drainage problems
11. History of cancer which required lymph node biopsy or dissection
12. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course
13. History of keloid scarring, abnormal wound healing and / or prone to bruising
14. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders
15. Use of isotretinoin (Accutane®) within 6 months of treatment or during the study
16. Subject on systemic corticosteroid therapy 6 months prior to and throughout the course of the study
17. Dysplastic nevi in the area to be treated
18. Participation in a study of another device or drug within 3 month prior to enrollment or during this study, if treatments of cellulite were involved
19. Subject has palpable lymphadenopathy at any visit. Standard palpation techniques will be used
20. Subjects with history of severe edema
21. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: all subjects; Treatment with the ePrime radiofrequency microneedling device in the upper thighs and buttocks	Device: ePrime; The main intent of the ePrime for cellulite is to utilize a minimally-invasive approach to directly deliver RF energy into tissue through pairs of micro-electrode needles and use temperature sensors within the needles to reliably create fractional thermal injuries within the skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs	Evaluate the efficacy of a single dermal and subcutaneous treatment with ePrime for the upper thighs and buttocks cellulite as assessed by blinded evaluators at 3 months post treatment visit.	Baseline and 3 months post treatment visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs	Evaluate the efficacy of a single dermal and subcutaneous treatment with ePrime for the upper thighs and buttocks cellulite as assessed by blinded evaluators at 6 months post treatment visit.	Baseline and 6 months post treatment visit
Number of Participants with Adverse Events	evaluate the safety of a single dermal and subcutaneous treatment with ePrime for the upper thighs and buttocks cellulite at 1 week post treatment, 1 month, 3 and 6 months following the treatment.	day 0 up to 7 months
Improvement in cellulite compared to baseline	Improvement in cellulite compared to baseline, as assessed by study investigators, using Nurnberger-Muller scale at 1 month, 3 and 6 months post treatment visit.	Baseline, 1 month, 3 and 6 months post treatment visit.
Investigator satisfaction - by questionnaire	Evaluate Investigator satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale	1, 3, and 6 months post-treatment visit
Subject satisfaction - by questionnaire	Evaluate subject satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale	1, 3, and 6 months post-treatment visit

Collaborators and Investigators

• Sponsor: Syneron Medical
• Investigators: Principal Investigator: Macrene Alexiades, MD, Dermatology and Laser Surgery Center 955 Park Avenue, New York, NY, 10028; Principal Investigator: Leyda Bowes, MD, Bowes Dermatology, 3659 South Miami Avenue, Suite # 6008, Miami, FL 33133; Principal Investigator: David Goldberg, MD, Skin Laser & Surgery Specialist of NY/NJ; Principal Investigator: Girish Munavalli, MD, Laser & Vein Specialists of the Carolinas, 1918 Randolph Road, Suite 550, Charlotte, NC 28270

Publications and helpful links

General Publications

• Rawlings AV. Cellulite and its treatment. Int J Cosmet Sci. 2006 Jun;28(3):175-90. doi: 10.1111/j.1467-2494.2006.00318.x.
• Rossi AB, Vergnanini AL. Cellulite: a review. J Eur Acad Dermatol Venereol. 2000 Jul;14(4):251-62. doi: 10.1046/j.1468-3083.2000.00016.x.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: June 25, 2015
• First Submitted That Met QC Criteria: July 2, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Estimate): March 18, 2016
• Last Update Submitted That Met QC Criteria: March 17, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Cellulite
• Other Study ID Numbers: DHF15911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED