adapalene
Fuentes regulatorias consultadas
Indicaciones aprobadas
- Tratamiento cutáneo del acné vulgar con predominio de comedones, pápulas y pústulas en cara, pecho o espalda.
Contraindicaciones
Absolutas
- Hipersensibilidad a adapaleno o a los excipientes; embarazo o planificación del embarazo.
Advertencias clínicas
- Advertencia mayor · Reducir la frecuencia o suspender temporal o definitivamente ante sensibilidad o irritación grave. No aplicar sobre cortes, abrasiones, quemadura solar, eccema ni acné grave en superficies extensas. — CIMA/AEMPS, ficha técnica 61066
- Evitar ojos, boca, alas de la nariz y mucosas, así como exposición solar o UV excesiva; usar fotoprotección y ropa protectora. — CIMA/AEMPS, ficha técnica 61066
- Advertencia mayor · Se han notificado reacción anafiláctica, angioedema y quemaduras en el lugar de aplicación, incluidas quemaduras de segundo grado o graves, con frecuencia no conocida. — CIMA/AEMPS, ficha técnica 61066
Interacciones medicamentosas
- SeveraOtros retinoides o medicamentos con un mecanismo similar
Mecanismo: La combinación puede aumentar la irritación y no está respaldada.
Recomendación: No usar conjuntamente.
CIMA/AEMPS, ficha técnica 61066https://cima.aemps.es/cima/dochtml/ft/61066/FT_61066.html
- ModeradaAgentes exfoliantes, astringentes o irritantes
Mecanismo: Pueden producir irritación local aditiva.
Recomendación: Separar los tratamientos; eritromicina, clindamicina o peróxido de benzoilo pueden usarse por la mañana si adapaleno se usa por la noche.
CIMA/AEMPS, ficha técnica 61066https://cima.aemps.es/cima/dochtml/ft/61066/FT_61066.html
Eventos adversos
Comunes (≥1%)
Sequedad cutánea · Irritación cutánea · Sensación de quemazón · Eritema
Embarazo y lactancia
Contraindicado durante el embarazo y en mujeres que planean quedar embarazadas. Puede utilizarse durante la lactancia, pero no debe aplicarse sobre el pecho para evitar la exposición del bebé.
Bibliografía reciente (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
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.
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. Topical adapalene has not been studied during breastfeeding. Because it is poorly absorbed after topical application, and blood levels are less than 0.25 mcg/L with long-term use, it is probably a low risk to the nursing infant.[1] Absorption should be minimized by applying it to the smallest possible surface area of the body for the shortest time possible. Do not apply to the nipple area and ensure that the infant’s skin does not come into direct contact with the areas of skin that have been treated.