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Rapid Acoustic Pulse Therapy for Cellulite
Study Summary
This trial will evaluate a device to treat cellulite in adults, assessing effectiveness & adverse events. Participants will receive 2 treatments, with regular visits & assessments.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I haven't had any cellulite treatments like liposuction or laser in the past year.I haven't had surgery in the treatment area in the last 3 months and don't plan to during the study.I have a blood clotting disorder or am on blood thinners.I haven't used spray-on tan for 3 months and won't use it during the trial.I want treatment for cellulite on my thighs or buttocks.I haven't used any cellulite creams for the last 3 months and won't use them during the trial.I have skin issues like infections, rashes, or psoriasis in the areas to be treated.You have noticeable cellulite on your thighs and/or buttocks, graded as 2 or 3 using specific scale and photos.I am looking for treatment for cellulite on my thighs or buttocks.I haven't had any cellulite treatments in the last year.I do not have any health conditions that would affect wound healing or my immune system.I haven't used spray-on tanning treatments for the last 3 months.
- Group 1: Rapid Acoustic Pulse (RAP)
- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is participation restricted to individuals aged 45 or younger?
"This trial is seeking individuals aged 18 to 50 for enrollment."
Are there any U.S.-based sites conducting this research project?
"This trial is running at four different sites, with Skin and Laser Surgery Center of New England in Nashua, Bellaire Dermatology in Bellaire, Union Derm in New york being three prominent locations. Additionally, there are another 4 medical centres involved."
To what degree is Rapid Acoustic Pulse (RAP) a potential risk to human health?
"With Phase 4 trials denoting that RAP is approved, our team at Power has deemed its safety to be a score of 3."
Does this investigation offer any opportunities for participants?
"According to clinicaltrials.gov, recruitment for this medical trial has ended; it was initially posted on February 7th 2023 and last updated on the 6th of that month. Nonetheless, there are presently seven other trials which actively require participants."
May I apply to participate in this trial?
"This clinical research is enlisting 60 participants aged 18 - 50 who are afflicted with cellulite. To be considered, applicants must demonstrate the presence of moderate to severe dimpling in their thighs and/or buttocks using a Cellulite Dimple- At Rest Scale at Baseline (Grade 2 or 3). Additionally, those seeking entry into this trial cannot have had any invasive energy-based treatments for 12 months preceding the study nor can they use topical based products within three months before or during the duration of participation. Lastly, spray tanning should not be used prior to enrollment and throughout its course."
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