isotretinoin
Sources réglementaires consultées
Indications approuvées
- Acné sévère nodulaire ou conglobata, ou à risque de cicatrices permanentes, résistant à un traitement antibactérien systémique et topique adéquat.
Contre-indications
Absolues
- Grossesse, projet de grossesse, allaitement ou femme en âge de procréer ne respectant pas le programme de prévention de la grossesse.
- Insuffisance hépatique, hyperlipidémie excessive, hypervitaminose A, traitement par tétracyclines ou hypersensibilité ; allergie à l’arachide ou au soja pour cette présentation.
Mises en garde cliniques
- Mise en garde majeure · Tératogène humain puissant : contraception efficace dès 1 mois avant, pendant et jusqu’à 1 mois après ; tests de grossesse avant, idéalement chaque mois pendant le traitement et 1 mois après. Arrêter et orienter immédiatement en cas de grossesse. — CIMA/AEMPS, ficha técnica 82566
- Mise en garde majeure · Surveiller l’état mental et arrêter ou évaluer en cas de dépression, idées suicidaires, agressivité ou psychose ; surveiller les lipides et la fonction hépatique et rechercher pancréatite, hypertension intracrânienne et troubles visuels. Les idées ou comportements suicidaires et la psychose sont de fréquence indéterminée. — CIMA/AEMPS, ficha técnica 82566
- Ne pas donner de sang pendant le traitement ni pendant 1 mois après. Éviter l’épilation à la cire, la dermabrasion agressive et le laser cutané pendant le traitement et pendant au moins 6 mois après. — CIMA/AEMPS, ficha técnica 82566
Interactions médicamenteuses
- SévèreTétracyclines
Mécanisme: Elles augmentent le risque d’hypertension intracrânienne bénigne.
Recommandation: L’usage concomitant est contre-indiqué.
CIMA/AEMPS, ficha técnica 82566https://cima.aemps.es/cima/dochtml/ft/82566/FT_82566.html
- SévèreVitamine A ou autres rétinoïdes
Mécanisme: Ils augmentent le risque d’hypervitaminose A et de toxicité des rétinoïdes.
Recommandation: Ne pas utiliser simultanément.
CIMA/AEMPS, ficha técnica 82566https://cima.aemps.es/cima/dochtml/ft/82566/FT_82566.html
- ModéréeKératolytiques ou exfoliants topiques antiacnéiques
Mécanisme: Ils peuvent augmenter l’irritation locale.
Recommandation: Éviter l’usage concomitant.
CIMA/AEMPS, ficha técnica 82566https://cima.aemps.es/cima/dochtml/ft/82566/FT_82566.html
Effets indésirables
Communs (≥1%)
Sécheresse cutanée · Chéilite · Épistaxis et sécheresse nasale · Conjonctivite et sécheresse oculaire
Rares mais graves
Réaction anaphylactique · Hypertension intracrânienne bénigne · Pancréatite · Hépatite
Grossesse et allaitement
Contre-indiquée pendant la grossesse et l’allaitement. L’exposition fœtale provoque de graves malformations et augmente les fausses couches ; arrêter et orienter en cas de grossesse.
Bibliographie récente (PubMed)
Acne vulgaris commonly affects adults, adolescents, and preadolescents aged 9 years or older. The objective of this study was to provide evidence-based recommendations for the management of acne. A work group conducted a systematic review and applied the Grading of Recommendations, Assessment, Development, and Evaluation approach for assessing the certainty of evidence and formulating and grading recommendations. This guideline presents 18 evidence-based recommendations and 5 good practice statements. Strong recommendations are made for benzoyl peroxide, topical retinoids, topical antibiotics, and oral doxycycline. Oral isotretinoin is strongly recommended for acne that is severe, causing psychosocial burden or scarring, or failing standard oral or topical therapy. Conditional recommendations are made for topical clascoterone, salicylic acid, and azelaic acid, as well as for oral minocycline, sarecycline, combined oral contraceptive pills, and spironolactone. Combining topical therapies with multiple mechanisms of action, limiting systemic antibiotic use, combining systemic antibiotics with topical therapies, and adding intralesional corticosteroid injections for larger acne lesions are recommended as good practice statements. Analysis is based on the best available evidence at the time of the systematic review. These guidelines provide evidence-based recommendations for the management of acne vulgaris.
Acne vulgaris is an inflammatory disease of the pilosebaceous unit of the skin that primarily involves the face and trunk and affects approximately 9% of the population worldwide (approximately 85% of individuals aged 12-24 years, and approximately 50% of patients aged 20-29 years). Acne vulgaris can cause permanent physical scarring, negatively affect quality of life and self-image, and has been associated with increased rates of anxiety, depression, and suicidal ideation. Acne vulgaris is classified based on patient age, lesion morphology (comedonal, inflammatory, mixed, nodulocystic), distribution (location on face, trunk, or both), and severity (extent, presence or absence of scarring, postinflammatory erythema, or hyperpigmentation). Although most acne does not require specific medical evaluation, medical workup is sometimes warranted. Topical therapies such as retinoids (eg, tretinoin, adapalene), benzoyl peroxide, azelaic acid, and/or combinations of topical agents are first-line treatments. When prescribed as a single therapy in a randomized trial of 207 patients, treatment with tretinoin 0.025% gel reduced acne lesion counts at 12 weeks by 63% compared with baseline. Combinations of topical agents with systemic agents (oral antibiotics such as doxycycline and minocycline, hormonal therapies such as combination oral contraception [COC] or spironolactone, or isotretinoin) are recommended for more severe disease. In a meta-analysis of 32 randomized clinical trials, COC was associated with reductions in inflammatory lesions by 62%, placebo was associated with a 26% reduction, and oral antibiotics were associated with a 58% reduction at 6-month follow-up. Isotretinoin is approved by the US Food and Drug Administration for treating severe recalcitrant nodular acne but is often used to treat resistant or persistent moderate to severe acne, as well as acne that produces scarring or significant psychosocial distress. Acne vulgaris affects approximately 9% of the pop
In 1982, the Food and Drug Administration (FDA) of the United States of America approved isotretinoin (13-cis-retinoic acid), a retinoid derivative of vitamin A, to treat severe recalcitrant acne vulgaris. Apart from its prescribed use for severe acne, evidence suggests that isotretinoin is commonly used off-label to treat mild-to-moderate acne, inflammatory skin conditions, genodermatoses, skin cancer, and other skin disorders. This is due to its anti-inflammatory, immunomodulatory, and antineoplastic properties. Some "off-label" use is successful, while others are ineffective. Therefore, this information is essential to clinicians for deciding on the appropriate use of isotretinoin. In this article, we aim to review the most updated evidence-based data about the use of oral isotretinoin in dermatology.
Perioral dermatitis is a common cutaneous condition characterized by acneiform facial eruptions often with an eczematous appearance. A granulomatous subtype exists in addition to the classic variant. While topical corticosteroids have been largely implicated in this condition, its etiology is not completely understood. Using the keywords "corticosteroids," "dermatology," "fusobacteria," "perioral dermatitis," and "periorificial dermatitis," we searched the databases PubMed, MEDLINE, and EMBASE to find the relevant literature. Only articles in English were chosen. The level of evidence was evaluated and selected according to the highest level working our way downwards using the Oxford Centre of Evidence-Based Medicine 2011 guidance. This systematic review found the strongest evidence to support topical corticosteroid misuse as the principal causative factor in the pathogenesis of perioral dermatitis. In terms of treatment, further research is required to robustly investigate promising treatment options including tetracyclines, topical metronidazole, topical azelaic acid, adapalene gel, and oral isotretinoin.
Acne vulgaris is very common and can have significant negative impact on people. While sometimes a transient problem, acne may persist for many years and often leads to permanent scars or pigment changes. Guidelines unanimously advise topical treatments as first-line, although differ in recommending either topical benzoyl peroxide or topical retinoid (mainly adapalene) alone or in combination. Guidance published by the National Institute for Health and Care Excellence advises counselling patients regarding avoidance of skin irritation when starting topical treatments and promoting adherence (treatments take 6-8 weeks to work). Oral antibiotics are currently overprescribed for acne but have a role when coprescribed with a non-antibiotic topical treatment. Hormonal treatments, such as the combined contraceptive pill, are also effective and there is growing evidence for the use of spironolactone for women with persistent acne. Recent guidance from the Medicines and Healthcare products Regulatory Agency regarding isotretinoin has implications for specialist prescribing and monitoring, and increasing public awareness of potential risks of mental health problems and sexual dysfunction. Although acne is associated with psychiatric disorder, the mental health effects of isotretinoin remain controversial.