Cellulite
Conditions
Keywords
Rapid Acoustic Pulse, RAP, Cellulite
Brief 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. 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.
Interventions
DEVICERapid Acoustic Pulse
Transdermal Rapid Acoustic Pulse Treatments
Sponsors
Zeltiq Aesthetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, 12 weeks post-final treatment | 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. |
| 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 | Week 1 up to 52 weeks post-final treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Agree or Strongly Agree Responses to the Participant Satisfaction Survey in the Improvement in Appearance of Cellulite | Baseline, 12 weeks post-final treatment | 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. |
Countries
United States
Participant flow
Recruitment details
Fourteen participants were enrolled at 1 study site in the United States.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 39.5 Years STANDARD_DEVIATION 5.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 2 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
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
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All 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 |
| All 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 |
| All 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 |
| All 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 |
| All 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 |
| All 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 |
Primary
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
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 % of images identified correctly |
Secondary
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
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Number of Participants With Agree or Strongly Agree Responses to the Participant Satisfaction Survey in the Improvement in Appearance of Cellulite | 5 participants |