Performance of the ePrime System for Cellulite
Primary Purpose
Cellulite
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ePrime
Sponsored by
About this trial
This is an interventional treatment trial for Cellulite
Eligibility Criteria
Inclusion Criteria:
- Subjects seeking treatment of cellulite in the upper thighs and buttocks areas.
- Subject have cellulite stage II or III as graded using Nurnberger-Muller scale clasification (Appendix III)
- Healthy female subjects ages 25 to 60 years of age
- Informed consent process completed and subject signed consent
- Willing to receive the proposed ePrime treatment and follow-up protocol
- 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)
- Willing to have photographs taken of the treated areas to be used de-identified in evaluations, publications and presentations
Exclusion Criteria:
- Subject had surgery or any other procedure for cellulite in the last 6 months
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
- Known allergy to lidocaine or epinephrine or antibiotics
- Active malignancy or history of malignancy in the past 5 years
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
- 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)
- 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)
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
- Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen
- History of significant lymphatic drainage problems
- History of cancer which required lymph node biopsy or dissection
- 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
- History of keloid scarring, abnormal wound healing and / or prone to bruising
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders
- Use of isotretinoin (Accutane®) within 6 months of treatment or during the study
- Subject on systemic corticosteroid therapy 6 months prior to and throughout the course of the study
- Dysplastic nevi in the area to be treated
- 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
- Subject has palpable lymphadenopathy at any visit. Standard palpation techniques will be used
- Subjects with history of severe edema
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
Sites / Locations
- Bowes Leyda
- David Goldberg
- Macrene Alexiades
- Girish Munavalli
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
all subjects
Arm Description
Treatment with the ePrime radiofrequency microneedling device in the upper thighs and buttocks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Investigator satisfaction - by questionnaire
Evaluate Investigator satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale
Subject satisfaction - by questionnaire
Evaluate subject satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02489994
Brief Title
Performance of the ePrime System for Cellulite
Official Title
Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of Cellulite
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Syneron Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of Cellulite.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulite
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
all subjects
Arm Type
Experimental
Arm Description
Treatment with the ePrime radiofrequency microneedling device in the upper thighs and buttocks
Intervention Type
Device
Intervention Name(s)
ePrime
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs
Description
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.
Time Frame
Baseline and 3 months post treatment visit
Secondary Outcome Measure Information:
Title
Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs
Description
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.
Time Frame
Baseline and 6 months post treatment visit
Title
Number of Participants with Adverse Events
Description
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.
Time Frame
day 0 up to 7 months
Title
Improvement in cellulite compared to baseline
Description
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.
Time Frame
Baseline, 1 month, 3 and 6 months post treatment visit.
Title
Investigator satisfaction - by questionnaire
Description
Evaluate Investigator satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale
Time Frame
1, 3, and 6 months post-treatment visit
Title
Subject satisfaction - by questionnaire
Description
Evaluate subject satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale
Time Frame
1, 3, and 6 months post-treatment visit
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects seeking treatment of cellulite in the upper thighs and buttocks areas.
Subject have cellulite stage II or III as graded using Nurnberger-Muller scale clasification (Appendix III)
Healthy female subjects ages 25 to 60 years of age
Informed consent process completed and subject signed consent
Willing to receive the proposed ePrime treatment and follow-up protocol
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)
Willing to have photographs taken of the treated areas to be used de-identified in evaluations, publications and presentations
Exclusion Criteria:
Subject had surgery or any other procedure for cellulite in the last 6 months
Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
Known allergy to lidocaine or epinephrine or antibiotics
Active malignancy or history of malignancy in the past 5 years
Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
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)
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)
History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen
History of significant lymphatic drainage problems
History of cancer which required lymph node biopsy or dissection
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
History of keloid scarring, abnormal wound healing and / or prone to bruising
History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders
Use of isotretinoin (Accutane®) within 6 months of treatment or during the study
Subject on systemic corticosteroid therapy 6 months prior to and throughout the course of the study
Dysplastic nevi in the area to be treated
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
Subject has palpable lymphadenopathy at any visit. Standard palpation techniques will be used
Subjects with history of severe edema
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Macrene Alexiades, MD
Organizational Affiliation
Dermatology and Laser Surgery Center 955 Park Avenue, New York, NY, 10028
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leyda Bowes, MD
Organizational Affiliation
Bowes Dermatology, 3659 South Miami Avenue, Suite # 6008, Miami, FL 33133
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Goldberg, MD
Organizational Affiliation
Skin Laser & Surgery Specialist of NY/NJ
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Girish Munavalli, MD
Organizational Affiliation
Laser & Vein Specialists of the Carolinas, 1918 Randolph Road, Suite 550, Charlotte, NC 28270
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bowes Leyda
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
David Goldberg
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Macrene Alexiades
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Girish Munavalli
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28270
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18489274
Citation
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.
Results Reference
background
PubMed Identifier
11204512
Citation
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.
Results Reference
background
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Performance of the ePrime System for Cellulite
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