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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05730335
Other study ID # M24-262
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date February 7, 2023
Est. completion date July 14, 2024

Study information

Verified date November 2023
Source Zeltiq Aesthetics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 59
Est. completion date July 14, 2024
Est. primary completion date November 3, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Rapid Acoustic Pulse
Transdermal Rapid Acoustic Pulse Treatments

Locations

Country Name City State
United States Bellaire Dermatology Bellaire Texas
United States Chicago Cosmetic Surgery and Dermatology Chicago Illinois
United States Skin and Laser Surgery Center of New England Nashua New Hampshire
United States Union Derm New York New York

Sponsors (1)

Lead Sponsor Collaborator
Zeltiq Aesthetics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants with Improvement in the Appearance of Cellulite as Determined by Blinded Independent Physician Reviewers (IPR) The number of before and after side-by-side photographs correctly identified by at least 2 of 3 blinded reviewers from the IPR panel. Week 16
Secondary Percentage of Participants with "Agree" or "Strongly Agree" Responses to the Participant Satisfaction Survey in the Improvement in Appearance of Cellulite The study participant demonstrates improvement by selecting ''Agree" or "Strongly Agree" as answers to the Participant Satisfaction Survey statement - 'In comparison to the pre-treatment photo, the 12 week photograph of the treatment area appears improved.' Week 16
Secondary Number of Participants with Adverse Events An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered by a medical device which does not necessarily have a causal relationship with the treatment. 60 Weeks
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