A Phase 4 interventional study of Rapid Acoustic Pulse in Cellulite, sponsored by Zeltiq Aesthetics. Completed at 4 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Zeltiq Aesthetics (part of AbbVie) · Phase 4, Interventional, and Treatment
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.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 59 is above the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →Zeltiq Aesthetics is the lead sponsor of 39 studies on the registry; none are open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 29 (100%) have results posted.
First submitted after Zeltiq Aesthetics became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will receive 2 separate RAP cellulite treatments sessions.
Device: Rapid Acoustic Pulse
Transdermal Rapid Acoustic Pulse Treatments
Also known as: RAP
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.
Time frame: Baseline, Week 12
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.
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
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.
Time frame: Week 1 up to Week 12
| Milestone | Rapid Acoustic Pulse (RAP) |
|---|---|
| Started | 59 |
| Received at least 1 study treatment | 59 |
| Completed 12-week post-final treatment visit | 51 |
| Completed 26-week post-final treatment visit | 48 |
| Completed 52-week post-final treatment visit | 45 |
| Completed | 45 |
| Not completed | 14 |
| Withdrew: Lost to follow-up | 8 |
| Withdrew: Withdrawal by subject | 6 |
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.
| % of images identified correctly | Rapid Acoustic Pulse (RAP) |
|---|---|
| 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 | 54.9 (40.3 to 68.9) |
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.
| Participants | Rapid Acoustic Pulse (RAP) |
|---|---|
| Left side | 26 |
| Right side | 21 |
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.
| Participants | Rapid Acoustic Pulse (RAP) |
|---|---|
| AEs | 2 |
| SAEs | 0 |
| ADEs | 1 |
| SADEs | 0 |
| Unanticipated AEs | 1 |
| Unanticipated ADEs | 0 |
Collected over From date of first treatment up to Week 52. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rapid Acoustic Pulse (RAP) | 0/59 (0%) | 3/59 (5.1%) | 6/59 (10.2%) |
| Event | Rapid Acoustic Pulse (RAP) |
|---|---|
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/59 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/59 |
| Tendon disorderMusculoskeletal and connective tissue disorders | 1/59 |
| Event | Rapid Acoustic Pulse (RAP) |
|---|---|
| FuruncleInfections and infestations | 1/59 |
| PapuleSkin and subcutaneous tissue disorders | 1/59 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/59 |
| SARS-CoV-2 test positiveInvestigations | 1/59 |
| ContusionInjury, poisoning and procedural complications | 1/59 |
| Chemical burns of eyeInjury, poisoning and procedural complications | 1/59 |
The Safety Population consists of all enrolled participants who received a treatment session (started or completed).
| Age, Continuous(years) | Rapid Acoustic Pulse (RAP) |
|---|---|
| Mean | 39.4 ± 7.65 |
| Sex: Female, Male(Participants) | Rapid Acoustic Pulse (RAP) |
|---|---|
| Female | 59 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Rapid Acoustic Pulse (RAP) |
|---|---|
| Hispanic or Latino | 13 |
| Not Hispanic or Latino | 46 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Rapid Acoustic Pulse (RAP) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 46 |
| More than one race | 1 |
| Unknown or Not Reported | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2023 to primary completion in Nov 2023, 8 months.
Results were first posted in Dec 2024, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.