Trial Outcomes & Findings for A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device for the Appearance of Cellulite in Adult Participants (NCT NCT05664581)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

Baseline, 12 weeks post-final treatment

Results posted on

2025-07-18

Participant Flow

Fourteen participants were enrolled at 1 study site in the United States.

The Full Analysis Set (FAS) included all participants who received three assigned treatments with the device and completed the 12-week follow-up visit per the protocol (N=14). The Safety Analysis Set included all enrolled participants who received any treatments (N=14).

Participant milestones

Participant milestones
Measure	All Participants Participants received 3 separate transdermal Rapid Acoustic Pulse (RAP) cellulite treatment sessions on weeks 1, 4, and 16 delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides.
Overall Study STARTED	14
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants Participants received 3 separate transdermal Rapid Acoustic Pulse (RAP) cellulite treatment sessions on weeks 1, 4, and 16 delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device for the Appearance of Cellulite in Adult Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=14 Participants Participants received 3 separate transdermal Rapid Acoustic Pulse (RAP) cellulite treatment sessions on weeks 1, 4, and 16 delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides.
Age, Continuous	39.5 Years STANDARD_DEVIATION 5.06 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks post-final treatment

Population: Full Analysis Set

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.

Outcome measures

Outcome measures
Measure	All Participants n=14 Photographs Participants received 3 separate transdermal Rapid Acoustic Pulse (RAP) cellulite treatment sessions on weeks 1, 4, and 16 delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides.
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 % of images identified correctly Interval 41.9 to 91.6

PRIMARY outcome

Timeframe: Week 1 up to 52 weeks post-final treatment

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	All Participants n=14 Participants Participants received 3 separate transdermal Rapid Acoustic Pulse (RAP) cellulite treatment sessions on weeks 1, 4, and 16 delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides.
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 AEs	2 Participants
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 SAEs	0 Participants
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 ADEs	2 Participants
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 SADEs	0 Participants
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 Unanticipated AEs	2 Participants
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 Unanticipated ADEs	0 Participants

SECONDARY outcome

Timeframe: Baseline, 12 weeks post-final treatment

Population: Full Analysis Set

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.

Outcome measures

Outcome measures
Measure	All Participants n=14 images Participants received 3 separate transdermal Rapid Acoustic Pulse (RAP) cellulite treatment sessions on weeks 1, 4, and 16 delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides.
Number of Participants With "Agree" or "Strongly Agree" Responses to the Participant Satisfaction Survey in the Improvement in Appearance of Cellulite	5 participants

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants n=14 participants at risk Participants received 3 separate transdermal Rapid Acoustic Pulse (RAP) cellulite treatment sessions on weeks 1, 4, and 16 delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides, and then were followed for up to 52 weeks post-last treatment.
General disorders Application Site Discoloration	14.3% 2/14 • Number of events 2 • All-cause mortality and adverse event tables include events reported from first treatment up to 52 weeks post-final treatment.
Skin and subcutaneous tissue disorders Blister	14.3% 2/14 • Number of events 2 • All-cause mortality and adverse event tables include events reported from first treatment up to 52 weeks post-final treatment.

Additional Information

Global Medical Services

AbbVie

Phone: 001 8006339110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patentor proprietary protection.
Publication restrictions are in place

Restriction type: OTHER