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Why Were Only 10 Patients Studied in the Cellulaze Clinical Trial?

Doesn't the FDA need a larger sample size to deem this as being effective for cellulite? Are there any other documented clinical trials for Cellulaze? I have battled cellulite my entire life and had a really bad experience with an invasive procedure called "lipodissolve" that was supposed to cure cellulite but instead caused me major bruising and pain. Hopefully this isn't similar to that.

Doctor Answers (5)

There Were not 10 Patients in the Clinical Trial

+1

I should anser this question since I performed bith this 10 patient initial "proof of Concept" study as well as the 57 patient trial performed at 6 centers nationwide for the final FDA data.  In the last paer as well as the first, there maintained an extremely high patient satisfaction.  The current paper was accpeted last week for publication in the Aesthetic Surgery Journal as well as been presented to plastic surgeon worldwide in the last year. thank you for your interest in Cellulaze and its developement

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Montclair Plastic Surgeon
4.0 out of 5 stars 36 reviews

Cellulaze Studies

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Cellulaze has been thoroughly investigated to ensure safer, more effective results. A clinical study showed that a single Cellulaze treatment improved the appearance of cellulite for one year with few side effects. Further, 93% of patients surveyed were satisfied or very satisfied with their results one year post-procedure, and all would recommend the Cellulaze treatment to a friend. The data also indicate compelling improvements in skin quality. Thicker, more elastic skin can help improve the appearance of cellulite. Cellulaze was shown to increase skin thickness by 25%, and skin elasticity by 29% even after 1 year —significant claims that other anti-cellulite treatments don't make.

Daniel Shapiro, MD
Scottsdale Plastic Surgeon
5.0 out of 5 stars 100 reviews

Why Were Only 10 Patients Studied in the Cellulaze Clinical Trial?

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That was ONLY the initial study. More studies are presently underway. The common denominator result is the greater than 80% subjective improvement of the treated patients. Again realistic expectations are very important and allowing 6 months post treatment before final analysis is done. Regards Dr. B, MIAMI 

Darryl J. Blinski, MD
Miami Plastic Surgeon
4.5 out of 5 stars 64 reviews

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The FDA Cellulaze trial included nearly 200 patients

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It is sometimes difficult to gather valid data on a new procedure, but I would recommend reading about Cellulaze in more detail.    I have been involved in cellulite treatment since 1999 and I have never seen anything that could produce lasting results with one treatment, and Cellulaze does.  Moreover, the clinical trial lasted two years and the results have been stable for that period.

 

Mario Diana, MD
Plano Plastic Surgeon
4.5 out of 5 stars 25 reviews

Clinical Trials & Laser Cellulite Treatment

+1
Thank you very much for your thoughtful question.  One of the most rewarding aspects of practicing Plastic Surgery is interacting with well informed patients who take the time to learn about treatments and ask pertinent questions. Real Self has been an extremely valuable forum.This leads to improved patient satisfaction and a gratifying doctor patient relationship. 
The laser wavelengths and technologies used to treat cellulite have been around and approved forsome time for treating the components of cellulite...fibrous attachement, thin skin and bulging fat.  When an approved technology is shown to be helpful in treating another condition, the process can be accelerated. The FDA and doctors have a responsibility to balance patient safety and the availability of treatments that affect patients. That being said, there is significant evidence that lasers can improve the components of cellulite significantly.  Best wishes in your fact finding.

Robert F. Centeno, MD, FACS
Fairfax Plastic Surgeon
5.0 out of 5 stars 38 reviews

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.