Clinical Studies & Research

Dr. Cox completed work as principal investigator in this follow-up to a recently completed study.  The follow-up “An Open Label, Multi-Center Trial to Assess the Safety of Single and Repeat Treatments of [product] for Injection for Treatment of Moderate to Severe Glabellar Lines” is an unblinded study with multiple treatments.   This new, Botox-like product is seeking registration for treatment of vertical lines between the eyebrows, and may eventually be the sixth injectable used to treat facial wrinkles and lines.  Each will be unique in some way, patients working with skilled injectors will benefit from the ability to match product characteristics to individual anatomy. It’s an interesting time in aesthetic medicine!   This study started in June 2017 and ended in December 2018.

Dr. Cox recently completed work as principal investigator for the study “A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of [product] for Injection to Treat Moderate to Severe Glabellar Lines”  This is another new, Botox-like product seeking registration for treatment of vertical lines between the eyebrows.  This is the third new product in as many years looking to displace market leader Botox in the treatment of facial lines.  Adding already registered Dysport and Xeomin to the mix means we’ll eventually have six (or more) injectables for treating facial lines.  Each of the products is unique in some way, and we’ve really enjoyed working with the manufacturers to identify which patients will most benefit from the characteristics of their product.  It’s an interesting time in aesthetic medicine!   This study began in November 2016 and just finished in December 2017.

Dr. Cox is serving as principal investigator in the study “Randomized Double Blind Phase 3 Study to Assess the Efficacy and Safety of [product] in the Treatment of Glabellar Lines in Comparison With Placebo Followed by an Open Label Extension Study.” This study is evaluating a new Botox-like product for treatment of vertical lines between the eyebrows.  We expect this will come to market in the next year or so.  As companies develop similar products with slightly different characteristics, there’s opportunity for skilled injectors to tailor treatments by selecting products best matched to an individual’s unique facial anatomy.  It’s customized aesthetic medicine and we’re excited about the possibilities.  The study began in October 2016 and is nearing completion.

Dr. Cox was a site clinician for the study “Qualitative Work on the Facial Lines Satisfaction Questionnaire (FLSQ) in Select Age Groups.”   This work continued the development of tools to assess patient satisfaction with treatment of facial lines.  In this case we applaud Allergan for supporting objective measurement of patient satisfaction.  Although we know the products work long before they come to market, the proof is whether patients agree once they’re out and in use.  The study was performed August through December 2016.

Dr. Cox was principal investigator in the study “A Multi-Center, Open Label, Multiple Dose, Phase II Trial to Demonstrate the Safety of [product] in Adult Subjects for Treatment of Moderate-to-Severe Glabellar Lines.”  This was a follow-up to an earlier study, evaluating multiple treatments in an unblinded study.  The product is coming to market soon, and when it arrives, the most experienced injector in the southeast will be right here in Chapel Hill!  Thank you to all the Triangle residents who helped us bring this exciting new Botox-like product to market.  The study was performed April 2014 to March 2017.

Dr. Cox was principal investigator for the study “A Multi-center, Randomized, Double-Blinded, Placebo-Controlled  Study Evaluating the Safety and Efficacy of [product] for the Reduction of Central Abdominal Bulging.”  This is the second study (different product) we’ve done evaluating an injectable treatment for belly fat.  We keep hoping one will come to market cause a few of us could use a little help !    The product has not been approved for this use, though we understand research on the molecule for injectable treatment of fat continues.  Stay tuned, we’ll keep you posted if we get any updates.  The study was performed April through August 2015.

Dr. Cox was principal investigator for the study A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Single Dose, Phase III Pivotal Trial to Demonstrate the Safety and Efficacy of [product] in Adult Subjects for Treatment of Moderate-to-Severe Glabellar Lines.”   This new product, similar to Botox, will be introduced soon.  With companies developing similar products with slightly different characteristics, the skill and experience of the injector will become even more important in getting the results you want in the most economical manner.  Our thanks to the Triangle residents who participated in this study.  You got an early look at this exciting new product, and hopefully learned a bit about clinical research in the aesthetic industry.  The study was performed October 2014 through November 2016.

Dr. Cox was principal investigator in the study “A Controlled, Randomized, Double-Blinded, Within-Subject, Multicenter, Prospective Clinical Study of [product] vs versus Perlane-L® in the Treatment of Moderate to Severe Nasolabial Folds.”  The study compared a new filler with an already marketed product for treatment of the nasolabial fold.  This new filler is expected soon, and when it hits the market, the most experienced injector will be right here at Aesthetic Solutions!  The study was active from August 2014 to August 2015.

Dr. Cox was principal investigator in the study “A Safety and Efficacy Study to Compare Dapsone Dermal Gel with Vehicle Control in Patients with Acne Vulgaris.”  The study evaluated a topical gel for treatment for acne, and was active from May 2014 to December 2016.

Dr. Cox was principal investigator in the study “A Prospective, Randomized, Controlled, Multi-Center, Study of the Safety and Effectiveness of JUVÉDERM® Ultra XC Injectable Gel versus Belotero Balance® for Perioral Lines.”  The study compared two fillers used to treat lines around the mouth.  The study was active from October 2013 through August 2015.