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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Rapid Acoustic Pulse (RAP) treatment for cellulite?

Research shows that a noninvasive acoustic subcision device using rapid acoustic pulses can significantly improve the appearance of cellulite after just one treatment. Additionally, a study on Acoustic Wave Therapy, which is similar, demonstrated improvements in skin firmness and texture, and a reduction in cellulite dimples. ^{1 2 3 4 5}

Is Rapid Acoustic Pulse Therapy safe for treating cellulite?

Studies show that Rapid Acoustic Pulse Therapy, also known as acoustic subcision or Acoustic Wave Therapy, is generally safe for treating cellulite, with no reported side effects in clinical trials. ^{1 2 3 4 6}

How does Rapid Acoustic Pulse Therapy for Cellulite differ from other treatments?

Rapid Acoustic Pulse Therapy is unique because it uses noninvasive acoustic waves to improve cellulite appearance in just one treatment session, unlike other methods that may require multiple sessions. This therapy works by delivering rapid acoustic pulses to the skin, which is different from treatments like Acoustic Wave Therapy that require several weekly sessions. ^{1 2 3 4 7}

Research Team

Zeltiq Aesthetics

Principal Investigator

Zeltiq Aesthetics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A randomized, controlled multicenter study evaluating focused ultrasound treatment for fat reduction in the flanks. [2019]

2. England 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. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Comparing safety and efficacy of acoustic subcision at two different rapid acoustic pulse rates to improve the appearance of cellulite. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Improvement in Cellulite Appearance After a Single Treatment Visit With Acoustic Subcision: Long-Term Findings From a Multicenter Clinical Trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

High-frequency ultrasound evaluation of cellulite treated with the 1064 nm Nd:YAG laser. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety, tolerability, and efficacy evaluation of the SlimME device for circumference reduction. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A Review of the Use of Ultrasound for Skin Tightening, Body Contouring, and Cellulite Reduction in Dermatology. [2018]