A Phase 4 interventional study of Rapid Acoustic Pulse in Cellulite, sponsored by Zeltiq Aesthetics. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-07-18.
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 short-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 15 participants will be enrolled in the study at 1 site in the United States.
Participants will receive 3 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 72 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 14 is below 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 3 separate RAP cellulite treatments sessions.
Device: Rapid Acoustic Pulse
Transdermal Rapid Acoustic Pulse Treatments
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 post-final 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, 12 weeks post-final treatment
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 adverse event (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 52 weeks post-final treatment
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 for response to photographs on the left and right side of the body.
Time frame: Baseline, 12 weeks post-final treatment
Fourteen participants were enrolled at 1 study site in the United States.
| Milestone | All Participants |
|---|---|
| Started | 14 |
| Completed | 12 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
Photographs of the treatment areas were taken at baseline, and at 12-weeks after post-final 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 | All Participants |
|---|---|
| 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 | 71.4 (41.9 to 91.6) |
An adverse event (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 | All Participants |
|---|---|
| AEs | 2 |
| SAEs | 0 |
| ADEs | 2 |
| SADEs | 0 |
| Unanticipated AEs | 2 |
| Unanticipated ADEs | 0 |
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 for response to photographs on the left and right side of the body.
| participants | All Participants |
|---|---|
| Number of Participants With "Agree" or "Strongly Agree" Responses to the Participant Satisfaction Survey in the Improvement in Appearance of Cellulite | 5 |
Collected over All-cause mortality and adverse event tables include events reported from first treatment up to 52 weeks post-final treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | 0/14 (0%) | 0/14 (0%) | 2/14 (14.3%) |
| Event | All Participants |
|---|---|
| Application Site DiscolorationGeneral disorders | 2/14 |
| BlisterSkin and subcutaneous tissue disorders | 2/14 |
Safety Population
| Age, Continuous(Years) | All Participants |
|---|---|
| Mean | 39.5 ± 5.06 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 14 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 12 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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