TR-987 0.1% active gel (Glucoprime) vs. placebo Gel following fractionated CO2 laser resurfacing of the chest

INTRODUCTION: Fractionated CO2 laser for photodamage, rhytides and scarring is associated with less pain, a shorter downtime and less intensive postoperative care compared to traditional ablative laser resurfacing. TR‐987 0.1% gel is an investigational gel that activates cellular pattern recognition receptors, which defend against pathogenic microorganisms and accelerate tissue repair. OBJECTIVE: The goal of this study is to determine the safety and efficacy of TR‐987 0.1% gel in accelerating wound healing after fractional CO2 laser resurfacing of the chest for treatment of photodamage and rhytides. MATERIALS AND METHODS: This is a single‐site, double‐blinded, randomized, placebocontrolled study. Forty adult subjects with chest wrinkling class of II or greater and elastosis Score of 6 or greater will be enrolled. All subjects will be treated using fractionated CO2 laser with standardized settings. After the procedure, the study coordinator will apply a postoperative gel, either TR‐987 or placebo. A total of 5 applications of post‐operative gel are applied daily. Blinded investigator and subject self‐assessments evaluating healing are performed daily and subjects are followed daily until healing is achieved. Long term assessment of wrinkling and elastosis are performed at day 28 and day 104. RESULTS AND CONCLUSION: At present, investigators are still blinded to the treatment each subject received. Forty subjects have been treated. Data from the second set of 20 patients is pending statistical analysis. On subject assessments, subjects rated less pain and itching with lot A compared to lot B. At day 28, lot A showed a 27% change in wrinkling and a 34% change in elastosis while lot B showed a 17% change in wrinkling and 30% change in elastosis. At day 60, lot A showed a 30% change in wrinkling and a 26% change in elastosis while lot B showed a 23% change in wrinkling and 26% change in elastosis.