Profound Dermal and SubQ Cartridges for the Treatment of Cellulite

NCT03078647 | Completed Results FDA Device

• 1 other identifier: DHF21711
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cellulite

Outcome Measures

Primary Outcomes (1)

• Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations

  Evaluate the improvement in global aesthetic appearance of cellulite in treated areas following a single dermal and/or subcutaneous treatment with Profound, as assessed by study investigators at 1,3 and 6 months post treatment visit. Investigators used the following scale: 0=No Change; 1= 1-24% improvement; 2=25-49% improvement; 3=50-74% improvement; 4=75-100% improvement. The analysis calculates the improvement over 25% (grades 2-4)

  1,3 and 6 months post-treatment

Secondary Outcomes (3)

• Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations

  1, 3 and 6 months post treatment visit.

• Investigator Satisfaction - by Questionnaire

  1, 3, and 6 months post-treatment visit

• Subject Satisfaction and Improvement - by Questionnaire

  1, 3, and 6 months post-treatment visit

Study Arms (1)

Profound treatment to small areas

EXPERIMENTAL

Single Profound treatment with the Dermal and/or SubQ cartridges to bra bulge, above the knees or upper arms

Device: Profound

Interventions

Profound DEVICE

The main intent of the Profound Dermal and Subdermal cartridges for cellulite treatment is to utilize a minimally-invasive approach to directly deliver radiofrequency (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.

Profound treatment to small areas

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent to participate in the study.
• Female subjects, ≥ 18 and ≤ 60 years of age at the time of enrollment
• Fitzpatrick Skin Type I to VI.
• Subjects seeking treatment of cellulite in the upper thighs and buttocks areas.
• Subject cellulite stage II or III as graded using Nurnberger-Muller scale classification (Appendix III).
• Not pregnant, 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).
• Negative urine pregnancy test as tested prior to each treatment and at the last visit for women of child bearing potential (e.g. not menopause).
• General good health confirmed by medical history and skin examination of the treated area.
• Willing to receive the proposed Profound treatment.
• Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
• Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.

You may not qualify if:

• Subject cellulite stage 0 or I as graded using Nurnberger-Muller scale classification (Appendix III).
• 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).
• 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 treatment 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.

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (2)

Macrene Alexiades

New York, New York, 10028, United States

Location

Girish Munavalli

Charlotte, North Carolina, 28270, United States

Location

Related Publications (5)

• 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.

  PMID: 18489274 BACKGROUND

• 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.

  PMID: 11204512 BACKGROUND

• Alexiades M, Berube D. Randomized, blinded, 3-arm clinical trial assessing optimal temperature and duration for treatment with minimally invasive fractional radiofrequency. Dermatol Surg. 2015 May;41(5):623-32. doi: 10.1097/DSS.0000000000000347.

  PMID: 25915628 BACKGROUND

• Alexiades M, Munavalli G, Goldberg D, Berube D. Prospective Multicenter Clinical Trial of a Temperature-Controlled Subcutaneous Microneedle Fractional Bipolar Radiofrequency System for the Treatment of Cellulite. Dermatol Surg. 2018 Oct;44(10):1262-1271. doi: 10.1097/DSS.0000000000001593.

  PMID: 30222637 BACKGROUND

• Alexiades M, Munavalli GS. Single Treatment Protocol With Microneedle Fractional Radiofrequency for Treatment of Body Skin Laxity and Fat Deposits. Lasers Surg Med. 2021 Oct;53(8):1026-1031. doi: 10.1002/lsm.23397. Epub 2021 Mar 25.

  PMID: 33764552 DERIVED

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Marketing
• Organization: Candela Corporation

doranr@candelamedical.com

(949) 599-7646

Study Officials

• Girish Munavalli, MD

  Laser & Vein Specialists of the Carolinas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 13, 2017
• Study Start: September 13, 2017
• Primary Completion: November 2, 2018
• Study Completion: January 31, 2019
• Last Updated: June 25, 2019
• Results First Posted: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)