If you’ve ever wondered how and on whom cosmetic procedure trials are conducted, now is your chance to find out. Ulthera, Inc., the company that developed the popular ultrasound skin treatment, is currently recruiting volunteers for a clinical trial. The official title of the trial, although a mouthful, says it all:
“Evaluation of the Ulthera System for Lifting and Tightening the Face and Neck Following Sculptra Treatment.”
Basically, the trial’s purpose is to see what kind of results can be achieved by using Ulthera’s Ultherapy treatment right after administering Sculptra.
Sculptra is a long-lasting dermal filler approved by the FDA in 2009. Injected directly into the face, it helps to plump the skin and correct wrinkles on the forehead and around the mouth.
Ultherapy, more commonly known as Ulthera, is a skin and tissue treatment which uses ultrasound to deliver energy beneath the skin, rejuvenating it from within. It’s not difficult to see why scientists would want to see how firm and lifted the skin could become if the two treatments were used together.
The trial will consist of up to 30 subjects, each randomly assigned to one of three groups:
• Group A will be treated with the Ulthera System device
• Group B will receive two Sculptra injection treatments spaced six weeks apart
• Group C will have two Sculptra sessions 6 weeks apart, followed by Ultherapy four months later.
To be eligible for the trial, subjects must meet all of the following criteria:
– In good health
– Between the ages of 35 and 60
– Have loose skin in the lower face and neck
– Grade 1 and 2 on the Knize Scale
Those ineligible for the trial include individuals with:
– Diseases that might affect wound healing
– Facial acne
– Scarring in the treatment areas
– Open wounds or lesions on the face
– Excessively loose skin on the face and neck
– Excessive subcutaneous fat in the face and neck
– Severe solar elastosis
– Metal stents or implants in the treatment area
– Hypersensitivity to injectable poly-L-lactic acid (found in Sculptra)
– A history of keloid formation or hypertropic scarring
The study began in May 2011 and is being conducted in Texas. The results will be examined in January 2012, with the entire study concluding in June 2012.
If you are interested in volunteering for the trial, please contact Stephanie Holden (firstname.lastname@example.org) or Laurie Grizzard (email@example.com) by e-mail or phone (214-370-9270). Additional information about the trial can be found at http://clinicaltrials.gov/show/NCT01422538.
ADDITIONAL ULTHERA TRIALS
Ulthera, Inc. is also conducting other clinical trials at this time. More commonly, they are before-and-after trials, measuring results based on the differences before and after treatment. Examples which fall into this category include studies on Ulthera’s effectiveness on darker skin and for treating eye wrinkles (expected completion for both is October 2011).
This trial wilth Sculptra is different because it is a comparative study, comparing the results from different groups subjected to different treatments. Ulthera also conducted another trial of this kind (completed July 2011), comparing the pain experience between patients who have never undergone dermatologic procedures and those who have.