Performance of the ePrime System for Cellulite

NCT ID: NCT02489994

Last Updated: 2016-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-10-31

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.

Conditions

Cellulite

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

all subjects

Treatment with the ePrime radiofrequency microneedling device in the upper thighs and buttocks

Group Type: EXPERIMENTAL

ePrime

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Syneron Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Macrene Alexiades, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology and Laser Surgery Center 955 Park Avenue, New York, NY, 10028

Leyda Bowes, MD

Role: PRINCIPAL_INVESTIGATOR

Bowes Dermatology, 3659 South Miami Avenue, Suite # 6008, Miami, FL 33133

David Goldberg, MD

Role: PRINCIPAL_INVESTIGATOR

Skin Laser & Surgery Specialist of NY/NJ

Girish Munavalli, MD

Role: PRINCIPAL_INVESTIGATOR

Laser & Vein Specialists of the Carolinas, 1918 Randolph Road, Suite 550, Charlotte, NC 28270

Locations

Bowes Leyda

Miami, Florida, United States

David Goldberg

Hackensack, New Jersey, United States

Macrene Alexiades

New York, New York, United States

Girish Munavalli

Charlotte, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18489274 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11204512 (View on PubMed)

Other Identifiers

DHF15911

Identifier Type: -

Identifier Source: org_study_id