adapalene
Regulatory sources consulted
Approved indications
- Cutaneous treatment of acne vulgaris with predominant comedones, papules, and pustules on the face, chest, or back.
Contraindications
Absolute
- Hypersensitivity to adapalene or excipients; pregnancy or plans to become pregnant.
Clinical warnings
- Major warning · Reduce frequency or stop temporarily or permanently if sensitivity or severe irritation occurs. Do not apply to cuts, abrasions, sunburn, eczema, or severe acne over large areas. — CIMA/AEMPS, ficha técnica 61066
- Avoid the eyes, mouth, sides of the nose, and mucous membranes, as well as excessive sunlight or UV exposure; use sunscreen and protective clothing. — CIMA/AEMPS, ficha técnica 61066
- Major warning · Anaphylactic reaction, angioedema, and application-site burns, including second-degree or severe burns, have been reported with unknown frequency. — CIMA/AEMPS, ficha técnica 61066
Drug interactions
- HighOther retinoids or medicines with a similar mechanism
Mechanism: The combination may increase irritation and is not supported.
Recommendation: Do not use together.
CIMA/AEMPS, ficha técnica 61066https://cima.aemps.es/cima/dochtml/ft/61066/FT_61066.html
- ModeratePeeling, astringent, or irritating agents
Mechanism: They may cause additive local irritation.
Recommendation: Separate treatments; erythromycin, clindamycin, or benzoyl peroxide may be used in the morning when adapalene is used at night.
CIMA/AEMPS, ficha técnica 61066https://cima.aemps.es/cima/dochtml/ft/61066/FT_61066.html
Adverse events
Common (≥1%)
Skin dryness · Skin irritation · Burning sensation · Erythema
Pregnancy and lactation
Contraindicated during pregnancy and in women planning pregnancy. It may be used during breastfeeding, but must not be applied to the breast to avoid infant exposure.
Recent literature (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.