CellulitePhase 4NCT05730335
A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device in Adult Participants for the Appearance of Cellulite
A Phase 4 study testing Rapid Acoustic Pulse in people with Cellulite, run by Zeltiq Aesthetics at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cellulite
- What is being tested?
- Rapid Acoustic Pulse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Feb 2023to 17 Jul 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Bellaire Dermatology
Bellaire, Texas, 77401
Chicago Cosmetic Surgery and Dermatology
Chicago, Illinois, 60654
Skin and Laser Surgery Center of New England
Nashua, New Hampshire, 03060
Union Derm
New York, New York, 10003
About this study
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
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.
Read more
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.
- Conditions
- Cellulite
- Being tested
- Rapid Acoustic Pulse
- Keywords
- Cellulite, Rapid Acoustic Pulse, RAP
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Acoustic PulseDevice
Also called RAP
Transdermal Rapid Acoustic Pulse Treatments
| Study group | Role | What they receive |
|---|---|---|
| Rapid Acoustic Pulse (RAP) | Experimental | Participants will receive 2 separate RAP cellulite treatments sessions. Receives: Device: Rapid Acoustic Pulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel
Photographs of the treatment areas were taken at baseline, and at 12-weeks after the first treatment to determine if the RAP treatment had the effect of improvement in the appearance of cellulite. The photographs were assessed by blinded independent reviewers (IPR) to correctly identify the 12-weeks post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers.
Measured: Baseline, Week 12
Secondary outcomes (2)
Number of Participants With "Agree" or "Strongly Agree" Responses to the Participant Satisfaction Survey in the Improvement in Appearance of Cellulite
The study participant responded to the Participant Satisfaction Survey statement, "In comparison to the pre-treatment photo, the 12 week photograph of the treatment area appears improved." Response choices to this statement were "Strongly Agree", "Agree", "Neutral", "Disagree", and "Strongly Disagree", with "Strongly Agree" representing the greatest perceived improvement in the appearance of cellulite. Reported here is the number of participants who responded with "Agree" or "Strongly Agree". Data are reported split per response to photographs on the left and right side of the body.
Measured: Baseline, Week 12
Number of Participants With Device-related or Treatment-related: Adverse Events (AEs), Serious AEs (SAEs), Adverse Device Events (ADEs), Serious ADEs (SADEs), Unanticipated AEs or Unanticipated ADEs
An AE was defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the participant to have occurred, or a worsening of a pre-existing condition. A SAE resulted in death, was life threatening, required hospitalization, was a persistent or significant disability/incapacity, a birth defect, or was an event that required medical intervention. An ADE was defined as any AE with a reasonable possibility (definitely, probably, possibly, or remotely related) that the event may have been caused by the study device only.
Measured: Week 1 up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start7 Feb 2023
- Primary completion3 Nov 2023
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CelluliteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeltiq Aesthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zeltiq Aesthetics, Study director, Zeltiq Aesthetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730335
- Sponsor's protocol ID
- M24-262
- Status last verified
- Jun 2025
- First submitted
- 6 Feb 2023
- Last updated
- 24 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05730335
- Acronym / sponsor ID
- M24-262
- Conditions
- Cellulite
- Keywords
- Cellulite, Rapid Acoustic Pulse, RAP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Zeltiq AestheticsIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapid Acoustic Pulse (RAP) | Experimental | Device: Rapid Acoustic PulseParticipants will receive 2 separate RAP cellulite treatments sessions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid Acoustic PulseAlso: RAPTransdermal Rapid Acoustic Pulse Treatments | Device | Rapid Acoustic Pulse (RAP) |
Primary outcome
Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel
Time frame: Baseline, Week 12
Photographs of the treatment areas were taken at baseline, and at 12-weeks after the first treatment to determine if the RAP treatment had the effect of improvement in the appearance of cellulite. The photographs were assessed by blinded independent reviewers (IPR) to correctly identify the 12-weeks post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers.
2 secondary outcomes
Number of Participants With "Agree" or "Strongly Agree" Responses to the Participant Satisfaction Survey in the Improvement in Appearance of Cellulite
Time frame: Baseline, Week 12
Number of Participants With Device-related or Treatment-related: Adverse Events (AEs), Serious AEs (SAEs), Adverse Device Events (ADEs), Serious ADEs (SADEs), Unanticipated AEs or Unanticipated ADEs
Time frame: Week 1 up to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeltiq Aesthetics study director
Zeltiq Aesthetics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rapid Acoustic Pulse in people with Cellulite, run by Zeltiq Aesthetics at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.