Back to resultsA Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device in Adult Participants for the Appearance of Cellulite
Primary Purpose
Cellulite
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rapid Acoustic Pulse
Sponsored by
About this trial
This is an interventional treatment trial for Cellulite focused on measuring Cellulite, Rapid Acoustic Pulse, RAP
Eligibility Criteria
Inclusion Criteria: Participants seeking treatment of cellulite in the thigh and/or buttock areas. Areas of moderate to severe cellulite on bilateral thigh and/or buttock using the Cellulite Dimple - At Rest Scale at Baseline with grades of 2 or 3 based on review of photos taken under the same lightening conditions planned for the trial. Participant will not have had invasive or energy-based cellulite (liposuction, subcision, RF, laser, ESWT, cryo-lipolysis, muscle stimulation, etc.) treatments in the treatment areas in the prior 12 months. Participant will not have used topical based cellulite treatments for prior 3 months and will not use during the trial Participant will not have used spray-on tanning treatments for 3 months prior to or during the term of the trial. Exclusion Criteria: Metal or plastic implants (vascular stent, or implants in the hips, knees, etc.) in the treatment areas. Active electronic implants such as pacemakers, defibrillators History of coagulopathy and/or on anticoagulant medication Skin disorders (skin infections or rashes, psoriasis, etc.) in the treatment areas. Medical disorder that would hinder wound healing or immune response. Any surgical procedure in the treatment areas in the prior 3 months or planned during the duration of the study. Any other condition/disease/situation which, as deemed by the PI, would preclude participant from safely participating in or completing the study visits or that may confound study results.
Sites / Locations
- Chicago Cosmetic Surgery and Dermatology
- Skin and Laser Surgery Center of New England
- Union Derm
- Bellaire Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rapid Acoustic Pulse (RAP)
Arm Description
Participants will receive 2 separate RAP cellulite treatments sessions.
Outcomes
Primary Outcome Measures
Percentage of Participants with Improvement in the Appearance of Cellulite as Determined by Blinded Independent Physician Reviewers (IPR)
The number of before and after side-by-side photographs correctly identified by at least 2 of 3 blinded reviewers from the IPR panel.
Secondary Outcome Measures
Percentage of Participants with "Agree" or "Strongly Agree" Responses to the Participant Satisfaction Survey in the Improvement in Appearance of Cellulite
The study participant demonstrates improvement by selecting ''Agree" or "Strongly Agree" as answers to the Participant Satisfaction Survey statement - 'In comparison to the pre-treatment photo, the 12 week photograph of the treatment area appears improved.'
Number of Participants with Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered by a medical device which does not necessarily have a causal relationship with the treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05730335
Brief Title
A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device in Adult Participants for the Appearance of Cellulite
Official Title
A Multi-Center, Prospective Study to Evaluate the Safety and Effectiveness of Multi-Treatment Regimen With Zeltiq Aesthetics, Inc. Rapid Acoustic Pulse (RAP)™ Device for the Improvement in the Appearance of Cellulite
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
October 21, 2023 (Anticipated)
Study Completion Date
July 14, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeltiq Aesthetics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cellulite is the rippling or dimpling of the skin most commonly located on the thighs and buttocks of women. Its appearance and texture are often likened to that of "cottage cheese" or an orange peel. Rapid Acoustic Pulse (RAP) is an electrohydraulic (EH) device developed to improve the appearance of cellulite through microscopic disruption of the connection between the skin and underlying tissue leading to a reduction in the severity of dimples and ridges. The purpose of this study is to assess adverse events and effectiveness of RAP in adults seeking treatment of cellulite.
RAP is an FDA approved device for the long-term improvement in the appearance of cellulite in the buttocks and thighs. Participants 18-50 years of age seeking treatment of cellulite will be enrolled. Up to 60 participants will be enrolled in the study at 4 sites in the United States.
Participants will receive 2 separate cellulite treatment sessions. Each treatment session will consist of RAP treatment delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides. The study duration is up to 60 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulite
Keywords
Cellulite, Rapid Acoustic Pulse, RAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rapid Acoustic Pulse (RAP)
Arm Type
Experimental
Arm Description
Participants will receive 2 separate RAP cellulite treatments sessions.
Intervention Type
Device
Intervention Name(s)
Rapid Acoustic Pulse
Other Intervention Name(s)
RAP
Intervention Description
Transdermal Rapid Acoustic Pulse Treatments
Primary Outcome Measure Information:
Title
Percentage of Participants with Improvement in the Appearance of Cellulite as Determined by Blinded Independent Physician Reviewers (IPR)
Description
The number of before and after side-by-side photographs correctly identified by at least 2 of 3 blinded reviewers from the IPR panel.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants with "Agree" or "Strongly Agree" Responses to the Participant Satisfaction Survey in the Improvement in Appearance of Cellulite
Description
The study participant demonstrates improvement by selecting ''Agree" or "Strongly Agree" as answers to the Participant Satisfaction Survey statement - 'In comparison to the pre-treatment photo, the 12 week photograph of the treatment area appears improved.'
Time Frame
Week 16
Title
Number of Participants with Adverse Events
Description
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered by a medical device which does not necessarily have a causal relationship with the treatment.
Time Frame
60 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants seeking treatment of cellulite in the thigh and/or buttock areas.
Areas of moderate to severe cellulite on bilateral thigh and/or buttock using the Cellulite Dimple - At Rest Scale at Baseline with grades of 2 or 3 based on review of photos taken under the same lightening conditions planned for the trial.
Participant will not have had invasive or energy-based cellulite (liposuction, subcision, RF, laser, ESWT, cryo-lipolysis, muscle stimulation, etc.) treatments in the treatment areas in the prior 12 months.
Participant will not have used topical based cellulite treatments for prior 3 months and will not use during the trial
Participant will not have used spray-on tanning treatments for 3 months prior to or during the term of the trial.
Exclusion Criteria:
Metal or plastic implants (vascular stent, or implants in the hips, knees, etc.) in the treatment areas.
Active electronic implants such as pacemakers, defibrillators
History of coagulopathy and/or on anticoagulant medication
Skin disorders (skin infections or rashes, psoriasis, etc.) in the treatment areas.
Medical disorder that would hinder wound healing or immune response.
Any surgical procedure in the treatment areas in the prior 3 months or planned during the duration of the study.
Any other condition/disease/situation which, as deemed by the PI, would preclude participant from safely participating in or completing the study visits or that may confound study results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeltiq Aesthetics
Organizational Affiliation
Zeltiq Aesthetics
Official's Role
Study Director
Facility Information:
Facility Name
Chicago Cosmetic Surgery and Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Skin and Laser Surgery Center of New England
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Union Derm
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Bellaire Dermatology
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device in Adult Participants for the Appearance of Cellulite
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