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.

Xeroderma Pigmentosum: General Aspects and Management

“…These molecules have demonstrated to exert a protective role against the development of cutaneous precancerous lesions. In particular, the oral administration of isotretinoin (Roaccutane) is considered as the most effective to prevent BCC and SCC, due to its control on the proliferation of keratinocytes [7,120,121].…”

Adverse Events in Isotretinoin Therapy: A Single-Arm Meta-Analysis

“…Depending on patient tolerance, the initial dose should be 0.5 mg/kg/day, and should then be gradually increased to 1.0 mg/kg/day for a 15- to 20-week course. The label-recommended cumulative dose, maintained in clinical trials, consensuses, and dermatological practice, ranges from 120–150 mg/kg [ 2 , 3 ].…”

“…While the exact mechanism is unknown among patients suffering from acne, isotretinoin inhibits infundibular hyperkeratinization and the formation of comedones and induces apoptosis in sebocytes, which in turn decreases sebum production. Thus, 13-cis retinoic acid reduces the size of sebum ducts, making the microenvironment less hospitable to bacteria and alters immune mechanisms and chemotaxis of polymorphonuclears and monocytes [ 3 , 4 , 5 ].…”

“…Thus, all women must use contraception agents. Other conditions that ISO can cause are inflammatory bowel disease by its interaction with intestinal epithelium, and dry eyes by the impact on meibomian cells [ 1 , 3 ].…”

Isotretinoin-Induced Inflammatory Bowel Disease: Is There a Real Association?

“…To date, isotretinoin has been the mainstay of AV treatment since its Food and Drug Administration (FDA) approval in 1982 [9]. Isotretinoin's side effects include growth retardation, abnormal healing, and depression; yet, they are rare and should not contraindicate drug use [10]. Nevertheless, isotretinoin has been controversially associated with the development of IBD [11].…”