A randomized, open-label, comparative study of efficacy of low-dose continuous versus low-dose intermittent oral isotretinoin therapy in moderate-to-severe acne vulgaris

Abstract

Background: Acne vulgaris is a chronic inflammatory disease of pilosebaceous units. Oral isotretinoin is recommended for patients with 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. Aims and Objectives: The aim of this study was to assess and compare the efficacy of oral isotretinoin in low-dose continuous and intermittent treatment of moderate-to-severe acne vulgaris. Materials and Methods: This was a prospective, randomized, open-labeled, comparative, efficacy study carried out at Outpatient Clinic in the Department of Dermatology in Mandya Institute of Medical Sciences, Mandya. Out of 120 patients screened, 100 patients were selected. Patients with moderate-to-severe acne were assigned equally (50 patients each) to one of the two treatment regimens using block randomization technique, Group A was given lowdose continuous regimen -20 mg of oral isotretinoin once daily for 4 months and Group B was given low-dose intermittent regimen -20 mg of oral isotretinoin once daily for 1 week out of every 4 weeks. The patients were followed up every 4 th week during the treatment period. A 6-month follow-up evaluation after the end of treatment was performed. The outcome of the therapy was based on the improvement in the global acne grading system (GAGS) score and patients' satisfaction with the treatment in the 4-point scale. Results: This study showed statistically significant clinical improvement and difference in GAGS score between Group A and Group B (P < 0.005). Conclusion: This study suggests that, considering clinical efficacy, low-dose continuous treatment is most suitable for patients with moderate-to-severe acne vulgaris.

Consensus on the use of oral isotretinoin in dermatology - Brazilian Society of Dermatology

“… 40 It was approved for severe acne (conglobata and nodular-cystic), but evidence demonstrated in controlled randomized clinical trials (CRCTs) since 1980, in systematic reviews (SRs), consensuses, and recommendations of dermatology societies allowed to expand the indication for nodular-cystic and moderate papulopustular forms resistant to other treatments, with tendency to scarring, and emotional and social functional impairment. 1 , 2 , 36 , 38 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 A single course of the drug leads to cure in two-thirds of patients. Recurrences may take place, but they are milder and manageable with topical treatments.…”

Low‐dose oral isotretinoin for the treatment of adult patients with mild‐to‐moderate acne vulgaris: Systematic review and meta‐analysis

“…Severe acne patients may be refractory to response, in particular, on lower doses. Five studies in the analysis included patients known to have mild-to-moderate acne, 21,[25][26][27]29 whereas severe acne patients in the other five studies 17,[22][23][24]28 was not excluded. Additionally, previous evidence has shown that acne patients with hormonal abnormalities or who take medications known to induce acne often respond differently to isotretinoin.…”

“…Study participants were followed during the treatment period for 6-8 months, [21][22][23][24][25][26][27] but the length of follow-up in three studies was only 4 months. 17,25,28 Study participants were followed after the end of the treatment for 6-12 months, 21,23,24,28,29 the length of the follow-up on the other hand, in three studies was only 2-3 months 17,22,26 and in two studies 25,27 they did not follow the participants up post-treatment. However, because it was clinically meaningful, relapse was investigated as a secondary meta-analytic outcome.…”

Isotretinoin for Treating Acne Vulgaris

“…Initially, isotretinoin is only indicated for nodulocystic AV cases. However, it is recently used for moderate to severe AV that does not respond well to topical combination therapy or systemic antibiotics [24]. Table 3 outlines some of the results from clinical trials of isotretinoin.…”

“…Prior to therapy, assessments include liver function tests, fasted lipid profile (including triglyceride level), blood glucose, creatinine, and complete blood count with differential counts. Screening for mood changes, psychosis, aggression, suicidal thoughts, skin changes, and visual changes can also be conducted prior to therapy [23,24].…”