COSTA MESA, Calif., March 20, 2015 /PRNewswire-iReach/ -- WCCT Global, a contract research organization headquartered in Orange County, CA, successfully completed a Phase 2 ophthalmology clinical trial for a topical investigational product labeled XAF5 created by Topokine Therapeutics to treat a condition known as steatoblepharon (commonly referred to as “eye bags”) by reducing subcutaneous fat. The study was a randomized, double-masked placebo controlled trial conducted at WCCT Global’s Ophthalmology center located in Santa Ana, CA. The study consisted of 90 adult patients, applying either the XAF5 ointment (60 patients) or a placebo (30 patients) once daily for ten weeks. The study was spearheaded by WCCT’s Director of Ophthalmology and Aesthetics, Dr. Michael A. Sheety, whose clinical trial expertise and Ophthalmology center’s resources were responsible for the success of the program. Dr. Sheety has conducted over 50 ophthalmology clinical trials, with a focus on the fields of Cosmetology/Aesthetics, and will be presenting the ophthalmology research results of the Topokine study at the America Academy of Dermatology on Saturday, March 21 during the “Late Breaking Research” Session during their annual meeting.
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The study was done on a condition -- common in adults over the age of 45 -- which affects 40 million Americans, and causes the face to appear visibly tired and worn. The study assessed results as reported by both physicians and patients, meeting its pre-specified primary endpoint of at least a 1-point improvement on the 5 point Lower Eyelid Steatoblepharon Severity (LESS) scale, created specifically for the study by a panel of physicians. Over half of the patients in the XAF5 group showed a bilateral improvement of at least 1 point.
The clinical trial was successful with a 100% completion rate and minimal adverse experiences, all of which were mild and reversible. If approved, the XAF5 Ointment will be the first in a novel class of topical medications aimed at treating subcutaneous fat. Jon Rojas, WCCT Global’s Chief Operating Officer, is optimistic about XAF5’s future, saying “I feel that this product will be an innovative new way of treating patients with this condition. The administering method for XAF5 is so novel and unique to the aesthetics fieldimagine being able to remove excess eyelid fat without any surgical procedures. The benefits to patients are huge: no hospital visits, the procedure is non-invasive, and recovery time is virtually non-existent; WCCT is very excited to be a part of this ground-breaking advancement.” For WCCT Global, this study marks the contract research organization’s entry into this particular field of research, and is looking forward to the potential for conducting similar ophthalmology clinical trials in the future.
More About WCCT Global:
WCCT Global is a multi-site, full service CRO of outsourced early drug development and late phase services to the pharmaceutical, biotechnology and medical device industries. As a drug development partner, WCCT Global collaborates with domestic and foreign innovator companies who need regulatory, program management, patient recruitment, data management and strategic consulting support, with an emphasis on overseeing and executing trials in special disease populations, pediatric populations, ethno-bridging, and cardiac safety. WCCT has extensive experience with healthy volunteer studies including First-in-Human (FIH), as well as specific therapeutic expertise in Allergy, Asthma, HCV, Ophthalmology, Renal, and Vaccines.
Media Contact:Matt Miller, WCCT Global, 714.668.1500 ext.2029, Matt.Miller@wcct.com
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SOURCE WCCT Global
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