A randomized open label comparative study to determine the various side effects and patient satisfaction of low dose continuous versus low dose intermittent oral isotretinoin therapy in moderate to severe acne vulgaris

摘要

Background: Acne Vulgaris is chronic inflammatory disease of pilosebaceous units. Oral isotretinoin is recommended for moderate to severe acne vulgaris who are not responding satisfactorily to conventional therapies. Recent reports indicate that acne patients have been benefiting from the low dose treatment protocols. However, long term daily use of this drug results in frequent side effects such mucocutaneous and systemic side effects. Our aim was to assess and compare the various side effects and patient satisfaction of oral isotretinoin in low dose continuous and intermittent treatment of moderate to severe acne vulgaris. Methods: This was a prospective randomized open labeled comparative study carried out at outpatient department in the Department of Dermatology in Mandya Institute of Medical sciences, Mandya. Patients with moderate to severe acne were assigned equally (50 subjects each) to one of the two treatment regimens by using block randomization technique, Group A was given low dose continuous regimen-20 mg oral isotretinoin once daily for 4 months and Group B was given low dose intermittent regimen-20 mg oral isotretinoin once daily for 1 week out of every 4 weeks. The patients were followed up every 4th week during the treatment period. The patients were examined and side effects were noted in each visit. A six month follow-up evaluation was done to analyze patient satisfaction. Results: Muco-cutaneous dryness was most common adverse effect noted in both the groups A and B. Itching (42%), Alopecia (44%), Myalgia (36%) were seen most commonly in group A and Acne flaring (47%) was most common with group B. With regard to patient satisfaction, in group A 42% were satisfied and 20% were very satisfied, in group B 36% were satisfied and 14% were very satisfied. Conclusions: Study suggests that, Muco-cutaneous dryness was most common side effect in both treatment regimens. Side effects were more frequent with low dose continuous than low dose intermittent isotretinoin regimen. Patient satisfaction was better in continuous regimen.