The product was allowed to air dry for 60 minutes following application Selleckchem MK5108 and was Sotrastaurin removed by gentle washing in the morning. Subjects were monitored monthly in the study clinic, where blood was drawn to measure serum rapamycin concentrations, the study product was examined, and photographs were taken. The study product was replenished as needed. Rapamycin concentrations were analyzed at the University of Texas Medical School at Houston rapamycin laboratory, using an Architect i1000 analyzer (Abbott Laboratories, Abbott Park, IL, USA). The investigational product was manufactured at no cost by Biomedical Development Corporation (San Antonio, TX, USA) by combining sirolimus Poziotinib with
Skincerity®. The company randomized the investigational product. The researchers and study subjects were not provided with the randomization information until all data had been collected. Biomedical Development Corporation had no role in the design of the trial; in the collection, analysis, or interpretation of the data; or in the writing of this manuscript. The authors vouch for the accuracy and completeness of the reported data. Data Collection and Statistical Methods Upon completion of the trial, subjects were asked if they “got better on the treatment”, if they “got worse on the treatment”, or if “the treatment made
no difference”. Statistical analysis was performed using a two-sided Fischer’s exact test. At each study visit, blood was drawn to measure selleckchem serum rapamycin concentrations and complete blood counts to assess for systemic absorption of the study product. Results Patient Demographics A total of 28 patients met the criteria for enrollment in the study: 15 men (54%) and 13 women (46%). The mean patient age at the time of study enrollment was 23 years; 72% of the patients were non-Hispanic Whites, 7% were Hispanic, 10% were African American,
7% were Asian, and 4% were Native American (table II). No subject who was invited to participate refused. Two subjects withdrew from the study, secondary to discomfort with product application (a burning sensation with application). Two subjects were withdrawn by the investigators, secondary to poor compliance with study protocols. One subject was withdrawn following prolonged hospitalization unrelated to the study product. Twenty-three subjects completed the entire study protocol. Table II Patient demographic data Rapamycin Concentrations Blood was drawn at each study visit to measure serum rapamycin concentrations. The limit of quantitation of this immunoassay was 1.0 ng/mL, and no subject reached that concentration during treatment. Complete Blood Counts Complete blood counts were performed by Quest Laboratories. No subject demonstrated a significant change in the white blood cell count, hemoglobin level, or platelet count during treatment.