Rapid Acoustic Pulse Therapy for Cellulite

Overseen By Alison Akbari

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Zeltiq Aesthetics

Must not be taking: Anticoagulants

Disqualifiers: Metal implants, Electronic implants, Skin disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

14 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called Rapid Acoustic Pulse (RAP) to evaluate its effectiveness in reducing cellulite, the dimpled skin often found on thighs and buttocks. The RAP device aims to improve skin appearance by breaking the connections between the skin and underlying tissue. Individuals with moderate to severe cellulite on their thighs or buttocks, who haven't received certain treatments in the past year, might be suitable candidates. Participants will undergo three treatment sessions and attend regular clinic visits to monitor effects and side effects. As a Phase 4 trial, this research seeks to understand how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anticoagulant medication (blood thinners).

What is the safety track record for the Rapid Acoustic Pulse (RAP) device?

Research shows that the Rapid Acoustic Pulse (RAP) device is generally safe for treating cellulite. In earlier studies, participants handled the RAP device well, with most experiencing no serious side effects. Data supports the device's safety, indicating that negative effects were rare. The FDA has approved the RAP device for temporarily improving the appearance of cellulite on the buttocks and thighs, confirming its safety. This approval indicates sufficient testing to prove its safety for use in these areas.

Overall, RAP treatment is considered safe, with few side effects reported in past research. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Rapid Acoustic Pulse (RAP) therapy is unique because it uses sound waves to address cellulite, unlike traditional treatments like topical creams, laser therapy, or surgery. Researchers are excited about this treatment because it offers a non-invasive approach that can target cellulite more effectively without the need for downtime or recovery. The RAP device delivers rapid pulses that break down fibrous bands beneath the skin, which are responsible for the dimpled appearance of cellulite, potentially offering quicker and more noticeable results.

What evidence suggests that the Rapid Acoustic Pulse device is effective for cellulite?

Research has shown that the Rapid Acoustic Pulse (RAP) device effectively treats cellulite. One study found that 70.4% of participants experienced an improvement of more than 1 point in their cellulite, and all participants noticed an enhanced appearance. The treatment was manageable and resulted in significant long-term improvements in cellulite appearance. The FDA has approved the RAP device for use on the buttocks and thighs, indicating strong evidence of its effectiveness in reducing cellulite appearance. Participants in this trial will undergo three separate RAP cellulite treatment sessions to further assess its effectiveness. ^{1 5 6 7 8}

Who Is on the Research Team?

Zeltiq Aesthetics

Principal Investigator

Zeltiq Aesthetics

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have significant cellulite on your thighs and/or buttocks, rated as grades 2 or 3 based on photos taken in similar lighting conditions to those used in the trial.

I haven't used any cellulite creams for the last 3 months and won't use them during the trial.

I haven't used spray-on tans for the last 3 months and won't during the trial.

Exclusion Criteria

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

Active electronic implants such as pacemakers, defibrillators

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 separate RAP cellulite treatment sessions delivered to bilateral thigh and/or buttock areas

24 weeks

Regular visits at a clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment, including medical assessments and questionnaires

48 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rapid Acoustic Pulse (RAP) Device

Trial Overview 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.

How Is the Trial Designed?

Group I: Rapid Acoustic Pulse (RAP) Experimental Treatment 1 Intervention

Participants will receive 3 separate RAP cellulite treatments sessions.

Who Is Running the Clinical Trial?

Zeltiq Aesthetics

Lead Sponsor

Trials

41

Recruited

1,800+

Published Research Related to This Trial

In a clinical trial with 17 patients, Acoustic Wave Therapy (AWT) showed significant improvements in cellulite treatment, including reduced dimples and improved skin texture, with a statistically significant effect size (MW = 0.6706).

The study found no side effects associated with AWT, indicating that it is a safe treatment option for patients dealing with cellulite.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo controlled, prospectively randomized, double-blinded study for the investigation of the effectiveness and safety of the acoustic wave therapy (AWT(®)) for cellulite treatment. Russe-Wilflingseder, K., Russe, E., Vester, JC., et al.[2015]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38091485/

Improvement in Cellulite Appearance After a Single ... 70.4% of participants had a >1-point reduction in cellulite score, 100% reported improved appearance, and the treatment significantly improved ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05664581

A Study to Assess the Adverse Events and Effectiveness of ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10833180/

Improvement in Cellulite Appearance After a Single ... Rapid acoustic pulse treatment significantly improved the long-term appearance of cellulite and was well-tolerated. Cellulite is a dermatologic ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04065711

Study of the Soliton Rapid Acoustic Pulse (RAP) Device for ... To evaluate the safety, and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the temporary improvement in the appearance of cellulite. Detailed ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K222629.pdf

K2 - accessdata.fda.gov The Resonic device is also indicated for long-term improvement in the appearance of cellulite as supported by clinical data demonstrating.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05199506

Study to Evaluate the Safety and Effectiveness of the RAP ... The purpose of this single site clinical study is to evaluate the safety and effectiveness of the Soliton Rapid Acoustic Pulse (RAP) device for the improvement ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04065711

Study of the Soliton Rapid Acoustic Pulse (RAP) Device for ... Participant will not have used topical based cellulite treatments for prior 6 months and will not use during the trial. Will not undergo any other cellulite ...

8. resonic.com resonic.com/

Rapid Acoustic Pulse™: Cellulite Reduction | RESONIC™ RESONIC should not be used over areas with metal or plastic implants/devices, such as vascular stents or hip or knee implants and should not be placed in ...