Efficacy and safety of isotretinoin Lidose®

Abstract

Introduction. Acne is a common chronic inflammatory disease, which is accompanied by severe social stress and reduces the quality of life of patients. Isotretinoin is the gold standard for the treatment of severe and moderate forms of acne, and is also used when there is a risk of developing a post-acne symptom complex and when previous treatment methods are ineffective.Purpose of the study. To determine the effectiveness and safety of various isotretinoin regimens at a dose of 0.4–0.8 mg/kg in patients with moderate to severe acne vulgaris and in patients with adult acne.Materials and methods. A single-center, prospective, parallel, controlled study involved 139 patients with acne vulgaris and adult acne, who were divided into 3 groups. 72 patients with acne vulgaris of moderate severity according to the IGA scale (group A1) and 37 patients with adult acne (group B) received isotretinoin (Accutane) at a dose of 0.4 mg/kg/day (cumulative dose 100 mg/kg) for 8 months. 30 patients with severe forms of acne vulgaris (group A1) received Accutane at a dose of 0.8 mg/kg/day (cumulative dose 120 mg/kg) for 8 months. The study lasted 24 months. and consisted of 4 visits (1st visit, 4, 8 and 24 months), at each visit photocontrol was performed, the number of inflammatory and non-inflammatory elements was calculated, the DAI index and the degree on the IGA scale were determined.Results. All 139 patients achieved ‘clear’ or almost ‘clear’ skin according to the IGA scale after 8 months of therapy. There was also a statistically significant decrease in non-inflammatory and inflammatory elements in all groups after 4 and 8 months. (p < 0.001). The total DIA score after 8 months was reduced in group A1 by 89.2%, in group A2 by 83.78% and in group B by 80.3%. Acne recurrence after 24 months was determined in five patients.Conclusions. Various regimens of Accutane for moderate and severe acne vulgaris, as well as adult acne, have demonstrated high efficacy and a favorable safety profile.