azelaic acid
Regulatory sources consulted
Approved indications
- Relief of mild-to-moderate facial papulopustular acne and topical treatment of papulopustular rosacea.
Contraindications
Absolute
- Hypersensitivity to azelaic acid or excipients.
Clinical warnings
- Major warning · Avoid the eyes, mouth, and mucous membranes; rinse thoroughly with water after contact. Worsening asthma has rarely been reported. — CIMA/AEMPS, ficha técnica 65365
Drug interactions
- ModerateAlcoholic cleansers, tinctures, astringents, abrasives, or peeling agents
Mechanism: They may increase irritation, especially in rosacea.
Recommendation: Avoid concomitant use on the treated area.
CIMA/AEMPS, ficha técnica 65365https://cima.aemps.es/cima/dochtml/ft/65365/FT_65365.html
Adverse events
Common (≥1%)
Application-site burning · Application-site pain · Application-site itching · Local rash, paresthesia, dryness, or edema
Rare but serious
Hypersensitivity with possible angioedema or dyspnea · Worsening asthma
Pregnancy and lactation
Systemic absorption after topical use is minimal and fetal exposure is not expected. Azelaic acid is naturally present in human milk; when used as directed, clinically relevant skin absorption that would change its milk concentration or milk production is unlikely, so exposure of the breastfed infant is not expected.
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.
AZA is a non-phenolic, saturated dicarboxylic acid with nine carbon atoms, naturally produced by the yeast Malassezia. It has diverse physiological activities, including antibacterial, anti-keratinizing, antimelanogenic, antioxidant and anti-inflammatory effects. AZA is widely used in dermatology and is FDA-approved for treating papulopustular rosacea. It also shows significant efficacy in acne vulgaris and melasma. This review summarizes the mechanisms of action and clinical applications of AZA, aiming to provide theoretical support for its clinical and cosmetic use and to facilitate further research.
Azelaic acid has numerous pharmacological uses in dermatology. Its anti-inflammatory and anti-oxidant properties are thought to correlate with its efficacy in papulopustular rosacea and acne vulgaris, amongst other cutaneous conditions. We conducted a review of the literature on the use of azelaic acid in dermatology using key terms 'acne', 'azelaic acid', 'dermatology', 'melasma', 'rosacea', searching databases such as MEDLINE, EMBASE and PubMed. Only articles in English were chosen. The level of evidence was evaluated and selected accordingly listing the studies with the highest level of evidence first using the Oxford Center of Evidence-Based Medicine 2011 guidance.This review found the strongest evidence supporting the use of azelaic acid in rosacea, followed by its use off-label in melasma followed by acne vulgaris. Weaker evidence is currently available to support the use of azelaic acid in several other conditions such as hidradenitis suppurativa, keratosis pilaris and male androgenic alopecia.Azelaic acid, as a monotherapy or in combination, could be an effective first-line or alternative treatment, which is well-tolerated and safe for a range of dermatological conditions.