Patients and study design
CIN
DEL, CIN
In order to evaluate and compare the long-term efficacy and safety of topical IFNα2b and MMC for CIN therapy, a phase IIb, randomized, double-blind clinical trial with a two-year follow-up was conducted. Institutional Review Board (IRB)/Ethics Committee approval from the Instituto Mexicano del Seguro Social (IMSS), Centro Medico Nacional de Occidente, was obtained before enrollment of patients (IMSS Register Number R-2012-785-094). Written informed consent was obtained from all subjects before enrollment. All procedures related to the implementation of this study were supported in the tenets of the Declaration of Helsinki. Sample size was calculated using the Sample Size for Randomized Controlled Trials formula for which an alpha value of 0.05 and a power of 80% were chosen [