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

Abstract

Background: Isotretinoin is a synthetic retinoid, derived from vitamin A, with multiple mechanisms of action and highly effective in the treatment of acne, despite common adverse events, manageable and dose-dependent. Dose-independent teratogenicity is the most serious. Therefore, off-label prescriptions require strict criteria.

Objective: To communicate the experience and recommendation of Brazilian dermatologists on oral use of the drug in dermatology.

Methods: Eight experts from five universities were appointed by the Brazilian Society of Dermatology to develop a consensus on indications for this drug. Through the adapted DELPHI methodology, relevant elements were listed and an extensive analysis of the literature was carried out. The consensus was defined with the approval of at least 70% of the experts.

Results: With 100% approval from the authors, there was no doubt about the efficacy of oral isotretinoin in the treatment of acne, including as an adjunct in the correction of scars. Common and manageable common adverse events are mucocutaneous in nature. Others, such as growth retardation, abnormal healing, depression, and inflammatory bowel disease have been thoroughly investigated, and there is no evidence of a causal association; they are rare, individual, and should not contraindicate the use of the drug. Regarding unapproved indications, it may represent an option in cases of refractory rosacea, severe seborrheic dermatitis, stabilization of field cancerization with advanced photoaging and, although incipient, frontal fibrosing alopecia. For keratinization disorders, acitretin performs better. In the opinion of the authors, indications for purely esthetic purposes or oil control are not recommended, particularly for women of childbearing age.

Conclusions: Approved and non-approved indications, efficacy and adverse effects of oral isotretinoin in dermatology were presented and critically evaluated.

Keywords: Acne vulgaris; Dermatitis, seborrheic; Isotretinoin; Rosacea; Vitamin A.

Figure 1

18-year-old teenager, with moderate inflammatory acne on the face and trunk for four years, presenting scars, with a relevant negative impact on quality of life. The patient had been submitted to four cycles of oral cyclin, associated with topical combination of benzoyl peroxide and adapalene, with improvement and recurrence after two to three months. During the last cycle, the clinical picture worsened. The patient was treated with oral isotretinoin, 40 mg/kg/day (0.6 mg/kg/day), with total lesion regression after four months and maintenance for another month (total dose = 100 mg/kg/day) – regimen based on recent publications., , , Photos before and after treatment with oral isotretinoin. Maintenance treatment with adapalene 0.1% gel, for 12 months. There was no recurrence.

Figure 2

A 22-year-old patient with acne conglobata on the face alone for 15 months. Previously treated with oral antibiotics and topical products (whose names the patient was unable to report), without improvement. Treatment with isotretinoin 20 mg/day (0.3 mg/kg/day) and prednisone 40, 30, 20, and 10 mg/day every seven days was initiated. The duration of treatment, always with the same daily dose, was 18 months (160 mg/kg), until complete resolution of the lesions. A maintenance treatment with benzoyl peroxide 5% was maintained for 12 months. There was no recurrence.