Polycaprolactone for the correction of nasolabial folds: a 24-month, prospective, randomized, controlled clinical trial.

ABSTRACT

BACKGROUND: In this study, we examined two polycaprolactone (PCL)-based dermal filler formulas (PCL-1; PCL-2) for safety, patient satisfaction, likelihood to return, efficacy, and duration of correction. OBJECTIVE: This 40-patient, 24-month, prospective, randomized, controlled study evaluated the efficacy, safety, longevity, and volume of two PCL formulas for correction of nasolabial folds. METHODS: Patients enrolled in a medical clinic in Europe received two injections 1 month apart and returned at 3, 6, 9, 12, 15, 18, and 24 months for blinded patient evaluation using accepted aesthetic rating scales. RESULTS: At 12 months, the efficacy outcomes on Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale (GAIS) of PCL-1 and PCL-2 were consistently maintained, with sustained improvement in 90% and 91.4% of patients, respectively. At 24 months, PCL-2 was found to be more effective than PCL-1 with respect to GAIS and WSRS, showing sustained improvement for the entire 2-year study period (linear p = .52; quadratic p > .99). Patient satisfaction at 24 months was 72.4% for PCL-1 and 81.7% for PCL-2. Both products were found to be safe and well tolerated. CONCLUSIONS: PCL-1 and PCL-2 are safe and have sustained efficacy and high patient satisfaction, with PCL-2 demonstrating longer-lasting results than PCL-1.