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Research Center

BodyAesthetic Research Center (B.A.R.C.)

Phone: 314.628.8200
Fax: 314.880.0506

Niki Buettner, CCRC
nbuettner@bodyaesthetic.com

Jill Baum, RN, BSN, RNFA, CCRC
jbaum@bodyaesthetic.com

The BodyAesthetic Research Center was incorporated in 2008 as a way to create an infrastructure of people and processes that can support clinical trials without the overhead costs and bureaucracy associated with universities and large research organizations. The advantages of our smaller size and clinical trial experience make BodyAesthetic Research Center attractive to drug and device manufacturers who are seeking an independent study site associated with a private plastic surgery practice.

The Center's President, V. Leroy Young, MD, has been a board-certified plastic surgeon for more than 30 years. In the early 1990s, he incorporated basic and clinical research into his regular surgical duties at Washington University School of Medicine. Early projects were funded by small grants but eventually grew in size and complexity until additional staff and space were required. Dr. Young's partner in private practice and also a board-certified plastic surgeon, C.B. Boswell, MD, has also become increasingly involved in research studies as either a Principal Investigator or sub-investigator.

For the past 15 years, Dr. Young has played major leadership roles in the national plastic surgery professional societies and become part of a nationwide movement to improve the quality of clinical research related to plastic surgery. These connections with other plastic surgeons, who are also interested in conducting clinical trials, are viewed by study sponsors as an important benefit of working with our Center.

The Center typically uses national institutional review boards and has experience preparing and submitting IRB applications for single- and multi-center sites. We have also worked with the FDA to obtain Investigational New Drug (IND) approval to conduct a study of fat reduction injections based on a protocol we designed.

Currently Enrolling

Please call or email our Research Coordinators (listed at the top of this page) to find out about a current clinical trial we are conducting with women who are planning on having breast reconstruction. This study involves an investigational device which may make the reconstructive process better for the patient. More detail for this study will be posted soon.

COMING SOON

An investigational injectable medication that may help patients get rid of "CHIN FAT"-more information will be available in the near future but feel free to call our Research Coordinators listed at the top of this page if you may be interested in participating or would like more information. We would be able to take your name and contact information and get back with you when the enrollment begins for this trial

Facilities

The Research Center adjoins the BodyAesthetic Plastic Surgery & Skincare Center office, which means that at least one surgeon is nearly always available to research staff, study sponsors, and study subjects.

In the fall of 2010, the number of ongoing clinical trials at BodyAesthetic Research Center required expansion into an additional 2,600 sq. ft. space that is dedicated to research only. Features of the new Center include:

Examination and procedure rooms
A room for highly specialized photography with complex cameras and protocols, including 3-dimensional equipment
Several Private areas for obtaining informed consent
A properly CLIA-certified laboratory for drawing and processing blood, including a centrifuge
Certified training in Dangerous Goods Regulations (DGR) for shipping according to International Air Transport Association (IATA) guidelines
A locked storage room with refrigerators and a -20C freezer for safekeeping of study drugs
Dry ice storage capability
A large work surface for study monitors
A private conference room

For patient convenience, the BodyAesthetic Research Center is located in an area of St. Louis with a large medical services presence, including three hospitals (one across the street) and multiple diagnostic entities within 2 miles.

Staff

BodyAesthetic Research Center employs 2 Certified Clinical Research Coordinators (CCRCs), one of which is an RN/BSN who also functions as an RNFA (RN First Assistant) in the Operating Room. A coordinator with primary responsibility is assigned to every study, but each is also cross-trained in all study protocols and procedures. A medical writer is available to develop study protocols and consent documents.

Our clinical research coordinators are experienced in recruitment of subjects, IRB submissions, protocol and source document development, drawing and processing blood on-site, assisting with surgical procedures, reconstitution of IMP with multifaceted combinations per study cohort, using complex photographic equipment, scheduling off-site testing, and successfully managing the multitude of small details and considerable paperwork associated with clinical trials.

Clinical Trial Experience

The Center has experience conducting Phase I, II, III, and IV clinical trials, including randomized, blinded, controlled, and dose-ranging studies. Some are briefly described:

Phase II trials of injected drugs intended to improve the appearance of surgical scars (5 trials)
Phase II trials of a new injected drug designed to prevent keloid recurrence after their removal (3 trials with 1-year follow-up)
Phase II trial of an injected device to replace mid-face volume loss following massive weight loss (48-week follow-up)
Pilot study of an implanted device intended to improve the appearance of the nasolabial fold (12-month follow-up)
Phase II, III, and IV trials of silicone gel breast implants (4 studies with 10-year or 5-year follow-up)
Phase II trials of an injectable drug for reducing the amount of submental (chin) fat as measured with photography and MRI (9-month follow-up)
Pilot study of the safety and efficacy of injection lipolysis with phosphatidylcholine and deoxycholate acid for reducing subcutaneous fat in the abdomen as measured with MRI and tissue biopsies (submitted an IND application and received FDA approval)
Prospective, controlled study examining the effects of large-volume liposuction on insulin sensitivity, adipocyte metabolism, and body composition

In other experience, Dr. Young helped found the Center for Device Retrieval and Analysis at Washington University to study how silicone gel and saline breast implants fail by comparing the mechanical and physical properties of removed and never-implanted devices. He also played a leading role in establishing the National Breast Implant Registry, a growing database for tracking implants over time.

Other Features of BodyAesthetic Research Center

Large office facility dedicated to research only next to surgical practice
Central IRB's utilized - no Internal IRB necessary at our facility.
Prompt start-up time after sponsor approves study protocol
Experience with Electronic Data Capture (EDC) and Interactive Voice Response System (IVRS)
Good Clinical Practice and CITI training of investigators and coordinators
1st or 2nd in enrollment and retention for all multi-site studies undertaken since 2007
A primary research coordinator assigned to manage every trial
Research coordinator and Principal Investigator available for all monitoring visits
On-site phlebotomy and experience working with local or central laboratories
Good working relationships with nearby diagnostic imaging, pathology, and ECG facilities
Experience with various types of rating scales and quality-of-life instruments

Ongoing and Completed Clinical Trials

Ongoing

Excaliard Pharmaceuticals - 05/11 to Present
Protocol Number: EXC 001-204: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF VARIOUS DOSES AND REGIMENS OF EXC 001 FOR THE AMELIORATION OF SCARRING FOLLOWING REVISION OF SCARS FROM PRIOR BREAST SURGERY IN ADULT SUBJECTS

The New School for Social Research - 10/11 to Present
Understanding Patient Satisfaction and Quality of Life Following Facial Aesthetic Surgery: Development of a New Patient-Reported Outcome Measure a survey study

Kythera Biopharmaceuticals - 2/11 - present
Protocol (ATX-101-08-12) long-term follow-up study of subjects who completed Kythera-sponsored trials of ATX-101 (sodium deoxycholate injection) for the reduction of localized subcutaneous fat in the submental area

Allergan, Inc. - 2008 - present
Breast Implant Follow-up Study

Allergan, Inc. - 11/03 - present
McGhan Medical Corporation [Allergan] Silicone-Filled Breast Implant Adjunct Clinical Study

Completed

Excaliard Pharmaceuticals - 12/09 - 3/11
A Phase 2, Randomized, Double-Blind, Within-Subject Controlled Study to Evaluate Efficacy and Safety of EXC 001 for the Amelioration of Scarring Following Revision of Medial Scars Resulting from Prior Breast Reduction or Mastopexy Surgery in Adult Female Subjects

Allergan CED2009 - 11/10 - 12/10
A non-interventional observational and medical records review of patient outcomes with bimatoprost ophthalmic solution 0.03% (Latisse) for the treatment of hypotrichosis of the eyelashes

Allergan Inc., Protocol #: 19162-099 - 11/10 - 2/11
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex in Subjects with Facial Rhytides (Crow's Feet Lines and Glabellar Lines)" ("Study"). Principal Investigator. Chosen as the number one back-up site if recruitment was difficult.

Kythera Biopharmaceuticals - 12/09 - 12/10
Multicenter, randomized, double-blind, placebo-controlled study of ATX-101 (sodium deoxycholate injection) versus placebo for the reduction of localized subcutaneous fat in the submental area (SMF) using magnetic resonance imaging (MRI) and a battery of clinician- and subject-reported measurements

Excaliard Pharmaceuticals - 12/09 - 9/10
A Phase 2, Randomized, Double-Blind, Within-Subject Controlled Study to Evaluate Efficacy and Safety of EXC 001 for the Amelioration of Scarring of the Surgical Incision in Subjects Undergoing an Elective Abdominoplasty

Excaliard Pharmaceuticals - 11/09 - 9/10
A Phase 2, Randomized, Double-Blind, Within-Subject Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of EXC 001 for the Treatment of Incision Scars in the Pannus of Subjects Undergoing an Elective Abdominoplasty

Renovo Ltd. - 10/09 - 11/10
A Double Blind, Within Patient, Placebo Controlled Trial To Assess The Efficacy Of Juvista (Avotermin) In Conjunction With Scar Revision Surgery For The Improvement Of Disfiguring Scars

University of Pennsylvania, Dept. of Surgery - 06/09 - 6/10
Body Contouring Surgery Following Bariatric Surgery (sub-investigator site)

Renovo Ltd. - 2/09 - 11/10
A Single-Centre, Double Blind, Randomized, Exploratory Study to Explore the Efficacy and Safety of Juvista 250ng/100µL/linear cm When Administered Following Excision of Ear Lobe Keloids

Excaliard Pharmaceuticals - 09/08 - 04/09
An Observational Study to Delineate the Natural History of Scar Development, Evolution, and Resolution in Healthy Human Volunteers Undergoing an Elective Abdominoplasty

Renovo Ltd. - 07/08 - 11/09
A Single-Centre, Double Blind, Randomised, Tolerance Study to Investigate the Safety of Juvista 500ng/100µL/linear cm when Administered Following Excision of Ear Lobe Keloids

Aesthetic Surgery Education Foundation - 04/08 - 04/10
Metabolic and Structural Effects of Phosphatidylcholine and Deoxycholate Injections (lipodissolve) on Subcutaneous Fat

Medicis Aesthetics - 12/06 - 07/08
A Prospective, Open Label, Baseline- and No-Treatment-Controlled, Multi-Center Study of the Safety and Efficacy of Restylane® SubQ in the Temporary Soft Tissue Correction of Midfacial Volume Loss Related to Massive Weight Loss Following Bariatric Surgery

Renovo Ltd. - 11/06 - 3/09
A Single-Centre, Double Blind, Randomised, Rising Dose Tolerance Study To Investigate the Safety of Juvista When Administered Following Excision of Ear Lobe Keloids

Cook Biotech - 09/07 - 10/09
Surgisis Acellular Collagen Matrix Nasolabial Fold Soft Tissue Augmentation

Mentor Corporation - 09/05 - 09/08
Adjunct Study for Mentor H/S Silicone Gel-filled Mammary Prostheses

Allergan, Inc. - 11/99 - 04/10
McGhan Medical Corporation [Allergan] Silicone-Filled Breast Implant Core Clinical Study