What is the mechanism of action of this treatment?

Common treatments for cellulite, such as Rapid Acoustic Pulse (RAP), radiofrequency (RF), and ultrasound, work by targeting the structural issues beneath the skin. RAP uses electrohydraulic pulses to disrupt the connections between the skin and underlying tissue, reducing dimples and ridges. RF induces tissue contraction, and ultrasound enhances blood flow and promotes tissue regeneration. These mechanisms are important for cellulite patients as they address the root causes of cellulite, potentially improving skin texture and appearance.

What side effects are associated with this type of intervention?

The Rapid Acoustic Pulse (RAP) device, an FDA-approved treatment for cellulite, works by disrupting the connection between the skin and underlying tissue. Known side effects of similar treatments, such as focused ultrasound, include erythema (skin redness) and occasional mild discomfort. However, these treatments are generally well-tolerated with no significant adverse events reported. Other cellulite treatments, like aminophylline cream and endermologie, have shown minimal effectiveness and no significant side effects. Overall, non-invasive treatments for cellulite are considered safe with few reported adverse effects.

What prior FDA approvals exist?

The Rapid Acoustic Pulse (RAP) device is an FDA-approved treatment for the short-term improvement of cellulite appearance on the buttocks and thighs. This electrohydraulic device works by causing microscopic disruption of the connection between the skin and underlying tissue, reducing the severity of dimples and ridges. Other FDA-approved treatments for cellulite include various topical creams and mechanical devices, but RAP is notable for its specific mechanism of action involving acoustic pulses.

What other types of research exist?

Promising, novel alternatives to Rapid Acoustic Pulse (RAP) for cellulite treatment in 2024 include: 1) Acoustic Wave Therapy (AWT), which uses sound waves to break down cellulite and improve skin elasticity; 2) Laser treatments, such as Cellulaze, which target the fibrous bands under the skin and stimulate collagen production; 3) Radiofrequency (RF) treatments, like Venus Legacy, which use RF energy to heat the skin and underlying tissues, promoting collagen production and reducing cellulite; and 4) Injectable treatments, such as Qwo, which enzymatically break down the fibrous septae causing cellulite.

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Electrohydraulic Device

Rapid Acoustic Pulse Therapy for Cellulite

Phase 4

Waitlist Available

Research Sponsored by Zeltiq Aesthetics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Any surgical procedure in the treatment areas in the prior 3 months or planned during the duration of the study

Medical disorder that would hinder wound healing or immune response

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 weeks

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is testing a device called RAP that uses sound waves to improve the look of cellulite. It targets adults aged 18-50 who want to reduce cellulite on their thighs and buttocks. The sound waves break up tiny fibers under the skin, making it look smoother. Ultrasound is efficacious for skin rejuvenation, body contouring, and reduction of cellulite.

Who is the study for?

Adults aged 18-50 with moderate to severe cellulite on thighs or buttocks can join this trial. They shouldn't have had any tanning treatments, invasive cellulite procedures, or used topical cellulite treatments for the past 3 months. Those with metal/plastic implants, electronic devices like pacemakers, blood clotting issues, skin disorders in the area, or recent surgeries are excluded.

What is being tested?

The Rapid Acoustic Pulse (RAP) device is being tested for its effectiveness in improving the appearance of cellulite on the thighs and buttocks. Participants will undergo three treatment sessions and be monitored over a period of up to 72 weeks through medical assessments and questionnaires.

What are the potential side effects?

Potential side effects may include discomfort at the treatment site, bruising, swelling, redness or changes in skin sensation. The study aims to assess these adverse events thoroughly during regular clinic visits.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had surgery in the treatment area in the last 3 months and don't plan to during the study.

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I do not have any health conditions that could affect wound healing or my immune system.

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I have a blood clotting disorder or am on blood thinners.

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I have skin conditions like infections, rashes, or psoriasis in the areas to be treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Adverse Events

Percentage of Participants with Improvement in the Appearance of Cellulite as Determined by Blinded Independent Physician Reviewers (IPR)

Secondary study objectives

Percentage of Participants with "Agree" or "Strongly Agree" Responses to the Participant Satisfaction Survey in the Improvement in Appearance of Cellulite

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Rapid Acoustic Pulse (RAP)Experimental Treatment1 Intervention

Participants will receive 3 separate RAP cellulite treatments sessions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rapid Acoustic Pulse

2023

Completed Phase 4

~80

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cellulite, such as Rapid Acoustic Pulse (RAP), radiofrequency (RF), and ultrasound, work by targeting the structural issues beneath the skin. RAP uses electrohydraulic pulses to disrupt the connections between the skin and underlying tissue, reducing dimples and ridges. RF induces tissue contraction, and ultrasound enhances blood flow and promotes tissue regeneration. These mechanisms are important for cellulite patients as they address the root causes of cellulite, potentially improving skin texture and appearance.

Effects of ultrasound and trolamine salicylate phonophoresis on delayed-onset muscle soreness.Effect of different intensity pulsed ultrasound on the restoration of rat skeletal muscle contusion.Ultrasound modulates the inflammatory response and promotes muscle regeneration in injured muscles.