VelaShape III & UltraShape Power for Thigh Circumference Reduction

Circumference Reduction Clinical Trial

Official title:

Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for Thigh Circumference Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03430245
• Other study ID #: DHF24451
• Status: Completed
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: July 3, 2019

Study information

• Verified date: December 2019
• Source: Syneron Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, one-arm, baseline-controlled pilot study for the evaluation of the VelaShape III combined with UltraShape Power treatment for non-invasive circumference reduction to the thighs.

Description:

Eligible subjects will receive 3 bi-weekly treatments to the thighs at 2-week intervals, with the VelaShape III and UltraShape Power devices according to the study protocol.

Each subject will return for 3 follow up visits: four weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment (Tx.3), for total expected study duration of 16 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 3, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent to participate in the study.

2. Female and male subjects, 18 and 60 years of age at the time of enrollment.

3. Fitzpatrick Skin Type I to VI.

4. Fat thickness of at least 1.5 cm (measured by calibrated caliper).

5. BMI interval: 22 = BMI = 30 (normal to overweight, but not obese).

6. Female subjects 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. In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with child-bearing potential (e.g. not menopausal).

8. General good health confirmed by medical history and skin examination of the treated area.

9. Willing to follow the treatment and follow-up schedule and post-treatment care instructions.

10. Willingness to refrain from a change in diet/ exercise/medication regimen for the entire course of the study.

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. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism.

2. Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease.

3. Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.

4. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.

5. Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone.

6. Having undergone any other surgery in the treated areas within 12 months of treatment or during the study, including liposuction.

7. Previous body contouring procedures in the treatment area within 12 months.

8. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing.

9. Known photosensitivity.

10. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.

11. Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment area.

12. Very poor skin quality (i.e., severe laxity).

13. Abdominal wall diastasis or hernia on physical examination.

14. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months.

15. Obesity (BMI > 30).

16. Pregnant, childbirth within the last 12 months or breastfeeding women.

17. Any acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study.

18. Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months).

19. Inability to comply with circumference measurement procedure (e.g., inability to hold breath for the required duration).

20. Abdominal fat thickness lower than 2.5 cm after strapping.

21. Participation in another clinical study within the last 6 months.

22. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Related Conditions & MeSH terms

• Circumference Reduction

Intervention

Device:
• VelaShape III
The VelaShape III device combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum.
• UltraShape Power
The UltraShape Power device uses focused ultrasound energy for lipolysis (breakdown of fat) via a non-thermal mechanism of action.

Locations

Country	Name	City	State
United States	Skin Laser & Surgery Specialist of NY/NJ	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Syneron Medical

Country where clinical trial is conducted

United States, 

References & Publications (1)

Coleman WP 3rd, Coleman W 4th, Weiss RA, Kenkel JM, Ad-El DD, Amir R. A Multicenter Controlled Study to Evaluate Multiple Treatments With Nonthermal Focused Ultrasound for Noninvasive Fat Reduction. Dermatol Surg. 2017 Jan;43(1):50-57. doi: 10.1097/DSS.0000000000000918. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements	Circumference change of thigh midline post combined VelaShape III and UltraShape Power treatments. Negative change represent reduction in thigh circumference.	At 12 weeks after the third treatment (week 16) for each subject
Secondary	Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits	The thighs circumference change (at midline) after combined treatment with VelaShape III and UltraShape Power treatments compared to baseline.; The changed of thighs circumference was calculated at 2, 4, 8 and 12 weeks after baseline (which are second treatment , third treatment, 4 and 8 week follow-up visits, respectively).; Negative change represent reduction in thigh circumference.	At 2, 4, 8 and 12 weeks after baseline
Secondary	Investigator Satisfaction	Investigator satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (4, 8 and 12 weeks after the last treatment)	At 4, 8 and 12 weeks follow-up visits
Secondary	Subject Satisfaction	Subject satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (at 4, 8 and 12 weeks after the last treatment visit).	At 4, 8 and 12 week follow-up visits