BodyAesthetic Research Center (B.A.R.C.)
Jamie Archer, RN, BSN, Patient Coordinator:
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 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.
- 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.
BodyAesthetic Research Center employs 1 Clinical Certified Research Coordinator (CCRC) and 2 Registered Nurses both with their BSN. 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
- Phase I trial of injected drug to help reduce the formation of scars.
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
Some of Our Sponsors
- Allergan, Inc.
- Excaliard Pharmaceuticals
- Kimberly-Clark Corporation
- Kythera Biopharmaceuticals
- Medicis Aesthetics, Inc.
- Mentor Corporation
- Renovo Ltd.
- RXI Pharmaceuticals
Ongoing and Completed Clinical Trials
Kythera Biopharmaceuticals - 2/11 (Not Enrolling) 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 (Not Enrolling) Breast Implant Follow-up Study
Allergan, Inc. - 11/03 (Not Enrolling) McGhan Medical Corporation [Allergan] Silicone-Filled Breast Implant Adjunct Clinical Study
RXI-109-1201 - 5/11 (Not Enrolling)
A Phase 1 Single Center, Randomized, Double-Blind, Ascending Dose, Within-Subject Controlled Dose Escalation Study of RXI-109 for the Treatment of Incision Scars Made in the Pannus of Healthy Women Who Will Later Undergo Elective Abdominoplasty
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06473871 IN REDUCING HYPERTROPHIC SKIN SCARRING IN FEMALE SUBJECTS
Kimberly-Clark Corporation (11/12-12/13)
A Prospective, Multi-Center, Randomized, Open Label Controlled Trial Using a Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy.
Kythera Biopharmaceuticals - 4/11 (Not Enrolling)
ATX-101-11-23; Multicenter, randomized, double-blind, placebo-controlled, Phase 3 study ofáATX-101 (sodium deoxycholate injection) versus placebo for the reduction of localized subcutaneous fat in the submental area.
Cohera Medical Inc., - 5/11 - 12/13
A Prospective, Randomized, Controlled, Single-blind, Multicenter Clinical Trial Evaluating the Safety and Efficacy of the Cohera TissuGlu« Surgical Adhesive in the Management of Wound Drainage as Compared to the Standard of Care Closure Techniques Following Abdominolplasty.
Excaliard Pharmaceuticals - 05/11 to 5/12
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 6/12
Understanding Patient Satisfaction and Quality of Life Following Facial Aesthetic Surgery: Development of a New Patient-Reported Outcome Measure a survey study
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/100┬ÁL/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/100┬ÁL/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