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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid Acoustic Pulse (RAP) | Experimental | Participants will receive 2 separate RAP cellulite treatments sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid Acoustic Pulse | Device | Transdermal Rapid Acoustic Pulse Treatments |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zeltiq Aesthetics | Zeltiq Aesthetics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicago Cosmetic Surgery and Dermatology | Chicago | Illinois | 60654 | United States | ||
| Skin and Laser Surgery Center of New England |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 20, 2024 | Jun 3, 2025 |
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| 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. | Week 1 up to Week 12 |
| Nashua |
| New Hampshire |
| 03060 |
| United States |
| Union Derm | New York | New York | 10003 | United States |
| Bellaire Dermatology | Bellaire | Texas | 77401 | United States |
| Received at Least 1 Study Treatment |
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| Completed 12-Week Post-Final Treatment Visit |
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| Completed 26-Week Post-Final Treatment Visit |
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| Completed 52-Week Post-Final Treatment Visit |
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| COMPLETED |
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| NOT COMPLETED |
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The Safety Population consists of all enrolled participants who received a treatment session (started or completed).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 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. | The evaluable population included all treated participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | % of images identified correctly | Baseline, Week 12 | images | images |
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| 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 split per response to photographs on the left and right side of the body. | The evaluable population included all treated participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline, Week 12 |
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| Secondary | 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. | The Safety Population consists of all enrolled participants who received at least one treatment session (started or completed). | Posted | Count of Participants | Participants | Week 1 up to Week 12 |
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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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 59 | 3 | 59 | 6 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 26.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Furuncle | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Papule | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Chemical burns of eye | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 1, 2023 | Oct 11, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000071697 | Cellulite |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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