Trial Outcomes & Findings for A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device in Adult Participants for the Appearance of Cellulite (NCT NCT05730335)

Last Updated: 2025-06-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

59 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2025-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Rapid Acoustic Pulse (RAP) Participants received Transdermal RAP cellulite treatments on Week 1 and Week 4. Each treatment session consisted of RAP treatment delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides.
Overall Study STARTED	59
Overall Study Received at Least 1 Study Treatment	59
Overall Study Completed 12-Week Post-Final Treatment Visit	51
Overall Study Completed 26-Week Post-Final Treatment Visit	48
Overall Study Completed 52-Week Post-Final Treatment Visit	45
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Rapid Acoustic Pulse (RAP) Participants received Transdermal RAP cellulite treatments on Week 1 and Week 4. Each treatment session consisted of RAP treatment delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides.
Overall Study Lost to Follow-up	8
Overall Study Withdrawal by Subject	6

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rapid Acoustic Pulse (RAP) n=59 Participants Participants received Transdermal RAP cellulite treatments on Week 1 and Week 4. Each treatment session consisted of RAP treatment delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides.
Age, Continuous	39.4 years STANDARD_DEVIATION 7.65 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The evaluable population included all treated participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Rapid Acoustic Pulse (RAP) n=51 images Participants received Transdermal RAP cellulite treatments on Week 1 and Week 4. Each treatment session consisted of RAP treatment 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	54.9 % of images identified correctly Interval 40.3 to 68.9

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The evaluable population included all treated participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Rapid Acoustic Pulse (RAP) n=51 Participants Participants received Transdermal RAP cellulite treatments on Week 1 and Week 4. Each treatment session consisted of RAP treatment 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 Left side	26 Participants
Number of Participants With "Agree" or "Strongly Agree" Responses to the Participant Satisfaction Survey in the Improvement in Appearance of Cellulite Right side	21 Participants

SECONDARY outcome

Timeframe: Week 1 up to Week 12

Population: The Safety Population consists of all enrolled participants who received at least one treatment session (started or completed).

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.

Outcome measures

Outcome measures
Measure	Rapid Acoustic Pulse (RAP) n=59 Participants Participants received Transdermal RAP cellulite treatments on Week 1 and Week 4. Each treatment session consisted of RAP treatment 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 ADEs	1 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	1 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
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

Adverse Events

Rapid Acoustic Pulse (RAP)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rapid Acoustic Pulse (RAP) n=59 participants at risk Participants received Transdermal RAP cellulite treatments on Week 1 and Week 4. Each treatment session consisted of RAP treatment delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	1.7% 1/59 • From date of first treatment up to Week 52 The Safety Population consists of all enrolled participants who received a treatment session (started or completed).
Musculoskeletal and connective tissue disorders Arthralgia	1.7% 1/59 • From date of first treatment up to Week 52 The Safety Population consists of all enrolled participants who received a treatment session (started or completed).
Musculoskeletal and connective tissue disorders Tendon disorder	1.7% 1/59 • From date of first treatment up to Week 52 The Safety Population consists of all enrolled participants who received a treatment session (started or completed).

Other adverse events

Other adverse events
Measure	Rapid Acoustic Pulse (RAP) n=59 participants at risk Participants received Transdermal RAP cellulite treatments on Week 1 and Week 4. Each treatment session consisted of RAP treatment delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides.
Infections and infestations Furuncle	1.7% 1/59 • From date of first treatment up to Week 52 The Safety Population consists of all enrolled participants who received a treatment session (started or completed).
Skin and subcutaneous tissue disorders Papule	1.7% 1/59 • From date of first treatment up to Week 52 The Safety Population consists of all enrolled participants who received a treatment session (started or completed).
Respiratory, thoracic and mediastinal disorders Cough	1.7% 1/59 • From date of first treatment up to Week 52 The Safety Population consists of all enrolled participants who received a treatment session (started or completed).
Investigations SARS-CoV-2 test positive	1.7% 1/59 • From date of first treatment up to Week 52 The Safety Population consists of all enrolled participants who received a treatment session (started or completed).
Injury, poisoning and procedural complications Contusion	1.7% 1/59 • From date of first treatment up to Week 52 The Safety Population consists of all enrolled participants who received a treatment session (started or completed).
Injury, poisoning and procedural complications Chemical burns of eye	1.7% 1/59 • From date of first treatment up to Week 52 The Safety Population consists of all enrolled participants who received a treatment session (started or completed).

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

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 60 days 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 patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER