Inthesafety study, a 52-week open-labeltrial, Dr.Wortzman andcolleaguesreportedclindamycin-tretinoingel to be safe and well tolerated in 655 patients (meanage, 20years).
Obviously, an unblinded trial design (also known as an open-label trial) represents a particularly high-risk approach when the outcome involves a subjective assessment by either the patient or the physician.
Despite some limitations of trial design, including the open label nature of the study, RECORD remains the only randomized trial of cardiovascular outcomes for Avandia at this time.