Clinical trial NCT05730335: A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device in Adult Participants for the Appearance of Cellulite
Official title: A Multi-Center, Prospective Study to Evaluate the Safety and Effectiveness of Multi-Treatment Regimen With Zeltiq Aesthetics, Inc. Rapid Acoustic Pulse (RAP)™ Device for the Improvement in the Appearance of Cellulite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cellulite
Keywords: Cellulite
Rapid Acoustic Pulse
RAP
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2023-02-15
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Number of Participants With "Agree" or "Strongly Agree" Responses to the Participant Satisfaction Survey in the Improvement in Appearance of Cellulite
timeFrame: Baseline, Week 12
measure: 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
timeFrame: Week 1 up to Week 12
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Chicago Cosmetic Surgery and Dermatology
state: Illinois
city: Nashua
country: United States
facility: Skin and Laser Surgery Center of New England
state: New Hampshire
city: New York
country: United States
facility: Union Derm
state: New York
city: Bellaire
country: United States
facility: Bellaire Dermatology
state: Texas
Study officials:
affiliation: Zeltiq Aesthetics
name: Zeltiq Aesthetics
role: STUDY_DIRECTOR
References: