BackgroundAcne vulgaris, a chronic inflammatory disease of the pilosebaceous unit associated with socialisation and mental health problems, may a ect more than 80% of teenagers. Isotretinoin is widely recognised as a very e ective treatment for severe acne; however, it may cause adverse e ects. ObjectivesTo assess e icacy and safety of oral isotretinoin for acne vulgaris. Search methodsWe searched the following databases up to July 2017: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO and LILACS. We updated this search in March 2018, but these results have not yet been incorporated in the review. We also searched five trial registries, checked the reference lists of retrieved studies for further references to relevant trials, and handsearched dermatology conference proceedings. A separate search for adverse e ects of oral isotretinoin was undertaken in MEDLINE and Embase up to September 2013. Selection criteriaRandomised clinical trials (RCTs) of oral isotretinoin in participants with clinically diagnosed acne compared against placebo, any other systemic or topical active therapy, and itself in di erent formulation, doses, regimens, or course duration. Data collection and analysisWe used standard methodological procedures expected by Cochrane. Main resultsWe included 31 RCTs, involving 3836 participants (12 to 55 years) with mild to severe acne. There were twice as many male participants as females.Most studies were undertaken in Asia, Europe, and North America. Outcomes were generally measured between eight to 32 weeks (mean 19.7) of therapy.
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.
Acne is a chronic self-limited disease, which affects mostly teenagers, without gender difference. In recent years, the incidence has increased in female adults. The factors involved in this epidemiological observation are still under discussion in the literature. Clinically, acne is characterized by different types of lesions. The disease affects the regions rich in sebaceous glands (face, chest and upper back). The clinical lesions are: open and closed comedones, erythematous papules, pustules, nodules and different types of scars. Taking into consideration the general concept of inflammation (redness, pain, heat and loss of function), acne is traditionally classified as non-inflammatory (open and closed comedones) and inflammatory (other primary lesions). With the knowledge advancement this concept seems to be wrong and therefore acne would be an inflammatory disease even before the onset of their clinical lesions.
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