Performance of the ePrime System for Cellulite

Cellulite Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02489994
• Other study ID #: DHF15911
• Status: Active, not recruiting
• Phase: N/A
• First received: June 25, 2015
• Last updated: March 17, 2016
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: March 2016
• Source: Syneron Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cellulite

Intervention

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.

Locations

Country	Name	City	State
United States	Girish Munavalli	Charlotte	North Carolina
United States	David Goldberg	Hackensack	New Jersey
United States	Bowes Leyda	Miami	Florida
United States	Macrene Alexiades	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Syneron Medical

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Rossi AB, Vergnanini AL. Cellulite: a review. J Eur Acad Dermatol Venereol. 2000 Jul;14(4):251-62. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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.	No
Secondary	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	No
Secondary	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	No