RESUMO
OBJECTIVE: To demonstrate the effects of a new biphasic oral contraceptive (Oilezz) on cycle control as well as mild to moderate acne and facial seborrhea of healthy fertile Thai women. MATERIAL AND METHOD: The trial is a prospective, open, non-comparative, single center study. Fifty healthy, fertile Thai women with mild to moderate facial acne were recruited to study a specific drug (Oilezz) for 6 months. RESULTS: At the beginning, 66% of the subjects had mild acne and 34% had moderate acne. Significant improvements in facial seborrhea grades (as indicated by Sebutape assessments) were found after the first cycle. These improvements increased steadily and were much larger after the sixth cycle. There were no statistically significant changes in body weight or blood pressure during the study. No serious adverse events were reported. There were no mood changes, migraine, rash, abdominal discomfort, malaise, nausea and decrease in libido during the study period The premenstrual symptoms at initiation were 21 cases (42%). The symptoms were 4 (8%) with headache, 8 (16%) with breast tenderness, 5 (10%) with dysmenorrhea and one (2%) with bleeding irregularity. These symptoms were improved in the third and the sixth cycles. The percentage of women with spotting or bleeding increased after first cycle, compared with baseline and gradually decreased during subsequent cycles. After the sixth cycle of treatment, all subjects had improvement of acne. 80% of cases recovered from acne and there were only 20% had mild acne. CONCLUSION: Facial seborrhea and acne improved significantly with Oilezz. It is good to control cycle without change in body weight and blood pressure. Therefore, Oilezz can be used for treatment of seborrhea and acne and as a contraceptive.