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.

Tags:

Comment on this

5 Doctor Answers | Asked by ihatecellulite

Doctor Answers (5)
Community Comments (0)

There Were not 10 Patients in the Clinical Trial

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... more

Clinical Trials & Laser Cellulite Treatment

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... more

Cellulaze Studies

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... more

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

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

The FDA Cellulaze trial included nearly 200 patients

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.