An open-label, prospective, comparative, double-arm clinical trial to evaluate the safety and effectiveness of minocycline extended-release formulation compared with minocycline immediate-release formulation in the management of patients with papulopustular acne

Abstract

Introduction: Minocycline because of its multiple advantages is considered as first-line therapy in the management of acne. However, conventional formulations of minocycline are associated with multiple side effects, thus limiting its use. Thus, extended-release formulation of minocycline was developed. Materials and Methods: This was an open-label, prospective, interventional, comparative, double-arm study. Patients with papulopustular acne were either received minocycline extended release (ER) 1 mg/kg/day or minocycline immediate release (IR) 100 mg/day for a period of 8 weeks. Safety was assessed by analyzing the adverse event (AE) profile in both the groups. Effectiveness was assessed by analyzing improvement in the mean inflammatory lesion count. Results: A total of 100 patients were included in the study, 50 in each group. A total of four AEs were reported by 2 (4.0%) patients in the ER group, whereas ten AEs were reported by 5 (10.0%) patients in the IR group. The mean inflammatory lesion count in the ER group at baseline was 14.95 ± 3.76, whereas in the IR group, it was 14.52 ± 3.38. Significant decrease in inflammatory lesion count was observed in both the groups during treatment period. Conclusion: The results of this study prove that ER formulation of minocycline is associated with better improvement in acne compared to IR formulation. The study also proves that ER formulation is associated with better safety profile compared to IR profile.