benzoyl peroxide
Regulatory sources consulted
Approved indications
- Cutaneous wash for symptomatic treatment of moderate acne vulgaris.
Contraindications
Absolute
- Hypersensitivity to benzoyl peroxide or the excipients.
Clinical warnings
- Major warning · It may cause burning, erythema, scaling, edema, or blisters; reduce frequency or stop for severe irritation and discontinue if edema or blisters occur. — CIMA/AEMPS, ficha técnica 61387
- For external use only. Do not apply to damaged skin; avoid the eyes, mouth, nostrils, mucous membranes, sunlight, and UV light. It may bleach hair and fabrics. — CIMA/AEMPS, ficha técnica 61387
- Major warning · Facial swelling and allergic reactions, including local hypersensitivity and anaphylaxis, have been reported with unknown frequency. — CIMA/AEMPS, ficha técnica 61387
Drug interactions
- ModerateTretinoin, resorcinol, salicylic acid, sulfur, and other peeling, irritating, or drying products
Mechanism: Local effects may be additive.
Recommendation: Do not use them simultaneously on the same area.
CIMA/AEMPS, ficha técnica 61387https://cima.aemps.es/cima/dochtml/ft/61387/FT_61387.html
Adverse events
Common (≥1%)
Skin dryness · Erythema · Scaling · Burning sensation · Itching · Skin pain or irritation
Pregnancy and lactation
During pregnancy, use only if clearly necessary. During breastfeeding, use cautiously and do not apply to the breast to avoid accidental 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
There is ambiguity regarding the topical cosmetic ingredients preferred for common skin complaints. To determine which topical ingredients are frequently recommended by cosmetic dermatologists for fine lines and wrinkles, acne, redness, dark spots, large pores, dry skin, and oily skin. Literature review to develop long list of ingredients. Reduced by expert panel to most salient ingredients. Two rounds of Delphi consensus survey with second expert panel of clinicians and teachers. Comparative literature review to summarize published evidence supporting each consensus ingredient. List of 318 ingredients reduced by a panel of 17 dermatologists to 83. Two Delphi rounds completed by 62 dermatologists at 43 centers. Consensus achieved for 23 ingredients, including the following: azelaic acid (acne, dark spots); benzoyl peroxide (acne, oily skin); glycolic acid (acne, dark spots); mineral sunscreen (fine lines and wrinkles, redness); niacinamide (redness, dark spots); retinoids (fine lines and wrinkles, acne, dark spots, large pores, oily skin); salicylic acid (acne, oily skin); vitamin C (fine lines and wrinkles, dark spots). Most consensus ingredients supported by level 1b or 2b evidence. Some ingredients based on expert opinion. Consensus exists among expert cosmetic dermatologists regarding ingredients most useful for common dermatologic concerns. Topical benzoyl peroxide has not been studied during breastfeeding. Because only about 5% is absorbed following topical application, it is considered a low risk to the nursing infant.[1,2] Ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[3]
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.