Cellulite
Conditions
Brief summary
Clinical Study to Evaluate the Performance of the Profound System for the Treatment of Cellulite.
Detailed description
Up to 60 healthy female volunteers, seeking cellulite treatment, 18 to 60 years of age from up to 3 investigational sites. Prospective, open-label, baseline-controlled, two arms, randomized, clinical study to evaluate the Profound device using the Dermal and SubQ Cartridges for minimally-invasive treatment of the upper thighs and buttocks cellulite appearance. The treatment areas of the study subjects will be divided into two arms: 1. Arm 1 - the upper thigh/buttock on the left or right side of the body will undergo a single Profound treatment utilizing the Dermal and SubQ Cartridges 2. Arm 2 - the contralateral upper thigh/buttock side of the body will undergo a single Profound treatment utilizing the SubQ Cartridge only. Methodology described in protocol to evaluate efficacy of treatments will be carried out at each visit.
Interventions
DEVICEProfound
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.
Sponsors
Syneron Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Signed informed consent to participate in the study. 2. Female subjects, ≥ 18 and ≤ 60 years of age at the time of enrollment 3. Fitzpatrick Skin Type I to VI. 4. Subjects seeking treatment of cellulite in the upper thighs and buttocks areas. 5. Subject cellulite stage II or III as graded using Nurnberger-Muller scale classification (Appendix III). 6. 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). 7. 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). 8. General good health confirmed by medical history and skin examination of the treated area. 9. Willing to receive the proposed Profound treatment. 10. Willing to follow the treatment and follow-up schedule and post-treatment care instructions. 11. Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.
Exclusion criteria
1. Subject cellulite stage 0 or I as graded using Nurnberger-Muller scale classification (Appendix III). 2. Subject had surgery or any other procedure for cellulite in the last 6 months. 3. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding. 4. Known allergy to lidocaine or epinephrine or antibiotics. 5. Active malignancy or history of malignancy in the past 5 years. 6. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator. 7. 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). 8. Having a known anti-coagulative 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). 9. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications. 10. Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen. 11. History of significant lymphatic drainage problems. 12. History of cancer which required lymph node biopsy or dissection. 13. 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. 14. History of keloid scarring, abnormal wound healing and / or prone to bruising. 15. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders. 16. Use of isotretinoin (Accutane) within 6 months of treatment or during the study. 17. Subject on systemic corticosteroid therapy 6 months prior to and throughout the course of the study. 18. Dysplastic nevi in the area to be treated. 19. Participation in a study of another device or drug within 3 month prior to enrollment or during this study. 20. Subject has palpable lymphadenopathy at any visit. Standard palpation techniques will be used. 21. Subjects with history of severe edema. 22. As per the Investigator's discretion, any physical or mental condition that might make it unsafe for subject to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations | 1,3 and 6 months post-treatment | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations | 1, 3 and 6 months post treatment visit. | Evaluate the improvement in skin tightening in treated areas following a single dermal and/or subcutaneous treatment with Profound, as assessed by study investigators at 1 and 6 months post treatment visit. Investigators used the following scale: (0) No tightening/firmness; (1) Slightly visible tightening/firmness; (2) Visible tightening/firmness; (3) Very visible tightening/firmness. The analysis calculates the skin tightening improvement graded: (2) Visible tightening/firmness and (3) Very visible tightening/firmness |
| Investigator Satisfaction - by Questionnaire | 1, 3, and 6 months post-treatment visit | Evaluate Investigator satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale \[(-2) Very dissatisfied, (-1) Dissatisfied, (0) No opinion, (1) Satisfied, (2) Very satisfied\]. The analysis quantify investigator satisfaction (grades 1-2) |
| Subject Satisfaction and Improvement - by Questionnaire | 1, 3, and 6 months post-treatment visit | Evaluate subject satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction and improvement scale \[(-2) Very dissatisfied, (-1) Dissatisfied, (0) No opinion, (1) Satisfied, (2) Very satisfied\]. The analysis quantify subject satisfaction (grades 1-2) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treated on the Suprapatellar Subjects treated with the Profound Dermal, SubQ or both cartridges above the knees areas (on both the left and the right side) | 17 |
| Treated on the Suprapatellar Subjects treated with the Profound Dermal, SubQ or both cartridges above the knees areas (on both the left and the right side) | 34 |
| Treated on the Upper Arms Subjects treated with the Profound Dermal, SubQ or both cartridges on the upper arms (on both the left and the right side) | 11 |
| Treated on the Upper Arms Subjects treated with the Profound Dermal, SubQ or both cartridges on the upper arms (on both the left and the right side) | 22 |
| Treated on the Braline Subjects treated with the Profound Dermal, SubQ or both cartridges on the braline areas (on both the left and the right side) | 3 |
| Treated on the Braline Subjects treated with the Profound Dermal, SubQ or both cartridges on the braline areas (on both the left and the right side) | 6 |
| Total | 93 |
Baseline characteristics
| Characteristic | Treated on the Suprapatellar | Treated on the Upper Arms | Treated on the Braline | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 11 Participants | 3 Participants | 31 Participants |
| Age, Continuous | 49.4 years STANDARD_DEVIATION 8.8 | 53.8 years STANDARD_DEVIATION 6.8 | 46.7 years STANDARD_DEVIATION 14.6 | 50.7 years STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 11 Participants | 3 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 11 Participants | 3 Participants | 31 Participants |
| Region of Enrollment United States | 17 participants | 11 participants | 3 participants | 31 participants |
| Sex: Female, Male Female | 17 Participants | 11 Participants | 3 Participants | 31 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 11 | 0 / 3 |
| other Total, other adverse events | 1 / 17 | 0 / 11 | 0 / 3 |
| serious Total, serious adverse events | 0 / 17 | 0 / 11 | 0 / 3 |
Outcome results
Primary
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)
Time frame: 1,3 and 6 months post-treatment
Population: Suprapatellar areas- 17 subjects, 8 subjects (16 areas) had one assessment for both sides treated with the same parameters.~Upper Arms- 10 Subjects had one assessment for both sides treated with same parameters (1 subject dropped after 1 wk FU).~Braline areas- 3 subjects, one subject had one assessment for both sides treated with same parameters
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Treated on the Suprapatellar | Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations | Over 25% Improvement at 3 month FU | 16 Investigator Assessments |
| Treated on the Suprapatellar | Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations | Over 25% Improvement at 1 month FU | 11 Investigator Assessments |
| Treated on the Suprapatellar | Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations | Over 25% Improvement at 6 month FU | 15 Investigator Assessments |
| Treated on the Upper Arms | Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations | Over 25% Improvement at 3 month FU | 10 Investigator Assessments |
| Treated on the Upper Arms | Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations | Over 25% Improvement at 1 month FU | 7 Investigator Assessments |
| Treated on the Upper Arms | Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations | Over 25% Improvement at 6 month FU | 9 Investigator Assessments |
| Treated on the Braline | Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations | Over 25% Improvement at 1 month FU | 4 Investigator Assessments |
| Treated on the Braline | Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations | Over 25% Improvement at 6 month FU | 4 Investigator Assessments |
| Treated on the Braline | Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations | Over 25% Improvement at 3 month FU | 5 Investigator Assessments |
Secondary
Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations
Evaluate the improvement in skin tightening in treated areas following a single dermal and/or subcutaneous treatment with Profound, as assessed by study investigators at 1 and 6 months post treatment visit. Investigators used the following scale: (0) No tightening/firmness; (1) Slightly visible tightening/firmness; (2) Visible tightening/firmness; (3) Very visible tightening/firmness. The analysis calculates the skin tightening improvement graded: (2) Visible tightening/firmness and (3) Very visible tightening/firmness
Time frame: 1, 3 and 6 months post treatment visit.
Population: Suprapatellar areas- 17 subjects, 8 subjects (16 areas) had one assessment for both sides treated with the same parameters.~Upper Arms- 10 Subjects had one assessment for both sides treated with same parameters (1 subject dropped after 1 wk FU).~Braline areas- 3 subjects, one subject had one assessment for both sides treated with same parameters
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Treated on the Suprapatellar | Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations | Visible + very visible tightening at 6-month FU | 15 Investigator Assessments |
| Treated on the Suprapatellar | Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations | Visible + very visible tightening at 3-month FU | 14 Investigator Assessments |
| Treated on the Suprapatellar | Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations | Visible + very visible tightening at 1-month FU | 9 Investigator Assessments |
| Treated on the Upper Arms | Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations | Visible + very visible tightening at 6-month FU | 8 Investigator Assessments |
| Treated on the Upper Arms | Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations | Visible + very visible tightening at 1-month FU | 3 Investigator Assessments |
| Treated on the Upper Arms | Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations | Visible + very visible tightening at 3-month FU | 8 Investigator Assessments |
| Treated on the Braline | Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations | Visible + very visible tightening at 6-month FU | 4 Investigator Assessments |
| Treated on the Braline | Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations | Visible + very visible tightening at 3-month FU | 4 Investigator Assessments |
| Treated on the Braline | Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations | Visible + very visible tightening at 1-month FU | 4 Investigator Assessments |
Secondary
Investigator Satisfaction - by Questionnaire
Evaluate Investigator satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale \[(-2) Very dissatisfied, (-1) Dissatisfied, (0) No opinion, (1) Satisfied, (2) Very satisfied\]. The analysis quantify investigator satisfaction (grades 1-2)
Time frame: 1, 3, and 6 months post-treatment visit
Population: Suprapatellar areas- 17 subjects, 8 subjects (16 areas) had one assessment for both sides treated with the same parameters.~Upper Arms- 10 Subjects had one assessment for both sides treated with same parameters (1 subject dropped after 1 wk FU).~Braline areas- 3 subjects, one subject had one assessment for both sides treated with same parameters
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Treated on the Suprapatellar | Investigator Satisfaction - by Questionnaire | Investigator Satisfaction Grades 1-2 at 3mo FU | 21 Investigator Assessments |
| Treated on the Suprapatellar | Investigator Satisfaction - by Questionnaire | Investigator Satisfaction Grades 1-2 at 1mo FU | 13 Investigator Assessments |
| Treated on the Suprapatellar | Investigator Satisfaction - by Questionnaire | Investigator Satisfaction Grades 1-2 at 6mo FU | 17 Investigator Assessments |
| Treated on the Upper Arms | Investigator Satisfaction - by Questionnaire | Investigator Satisfaction Grades 1-2 at 3mo FU | 10 Investigator Assessments |
| Treated on the Upper Arms | Investigator Satisfaction - by Questionnaire | Investigator Satisfaction Grades 1-2 at 1mo FU | 8 Investigator Assessments |
| Treated on the Upper Arms | Investigator Satisfaction - by Questionnaire | Investigator Satisfaction Grades 1-2 at 6mo FU | 9 Investigator Assessments |
| Treated on the Braline | Investigator Satisfaction - by Questionnaire | Investigator Satisfaction Grades 1-2 at 1mo FU | 4 Investigator Assessments |
| Treated on the Braline | Investigator Satisfaction - by Questionnaire | Investigator Satisfaction Grades 1-2 at 6mo FU | 4 Investigator Assessments |
| Treated on the Braline | Investigator Satisfaction - by Questionnaire | Investigator Satisfaction Grades 1-2 at 3mo FU | 4 Investigator Assessments |
Secondary
Subject Satisfaction and Improvement - by Questionnaire
Evaluate subject satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction and improvement scale \[(-2) Very dissatisfied, (-1) Dissatisfied, (0) No opinion, (1) Satisfied, (2) Very satisfied\]. The analysis quantify subject satisfaction (grades 1-2)
Time frame: 1, 3, and 6 months post-treatment visit
Population: Suprapatellar areas- 17 subjects, 8 subjects (16 areas) had one assessment for both sides treated with the same parameters.~Upper Arms- 10 Subjects had one assessment for both sides treated with same parameters (1 subject dropped after 1 wk FU).~Braline areas- 3 subjects, one subject had one assessment for both sides treated with same parameters
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Treated on the Suprapatellar | Subject Satisfaction and Improvement - by Questionnaire | Subject Satisfaction Grades 1-2 at 3mo FU | 20 Subject Assessments |
| Treated on the Suprapatellar | Subject Satisfaction and Improvement - by Questionnaire | Subject Satisfaction Grades 1-2 at 1mo FU | 13 Subject Assessments |
| Treated on the Suprapatellar | Subject Satisfaction and Improvement - by Questionnaire | Subject Satisfaction Grades 1-2 at 6mo FU | 17 Subject Assessments |
| Treated on the Upper Arms | Subject Satisfaction and Improvement - by Questionnaire | Subject Satisfaction Grades 1-2 at 3mo FU | 10 Subject Assessments |
| Treated on the Upper Arms | Subject Satisfaction and Improvement - by Questionnaire | Subject Satisfaction Grades 1-2 at 1mo FU | 8 Subject Assessments |
| Treated on the Upper Arms | Subject Satisfaction and Improvement - by Questionnaire | Subject Satisfaction Grades 1-2 at 6mo FU | 10 Subject Assessments |
| Treated on the Braline | Subject Satisfaction and Improvement - by Questionnaire | Subject Satisfaction Grades 1-2 at 1mo FU | 2 Subject Assessments |
| Treated on the Braline | Subject Satisfaction and Improvement - by Questionnaire | Subject Satisfaction Grades 1-2 at 6mo FU | 4 Subject Assessments |
| Treated on the Braline | Subject Satisfaction and Improvement - by Questionnaire | Subject Satisfaction Grades 1-2 at 3mo FU | 2 Subject Assessments |