What is the recommended treatment regimen for mild to moderate acne and rosacea using azelaic acid?

From the Guidelines

For mild to moderate acne and rosacea, azelaic acid is typically recommended as a 15% formulation applied twice daily to clean, dry skin, as supported by the most recent evidence from 2024 1.

Treatment Regimen

• Azelaic acid should be applied as a thin layer over the entire affected area, not just individual lesions.
• Treatment should continue for at least 12 weeks to see optimal results.
• For acne, azelaic acid works by reducing inflammation and killing Propionibacterium acnes bacteria while normalizing skin cell turnover to prevent pore blockage.
• For rosacea, it decreases inflammation and reduces the redness and swelling characteristic of the condition.

Application and Combination Therapy

• Patients should follow azelaic acid application with a non-comedogenic moisturizer and sunscreen during daytime use.
• Azelaic acid can be used alone for mild cases or combined with other treatments like topical retinoids or oral antibiotics for more moderate cases.

Safety and Side Effects

• Common side effects include mild irritation, redness, dryness, or peeling, which typically subside after the first few weeks of use.
• If irritation persists, reducing application to once daily temporarily may help.
• Azelaic acid is pregnancy-safe (category B), making it an excellent option for women who are pregnant or planning pregnancy, as noted in guidelines from 2016 1.

Recommendation Basis

• The recommendation for azelaic acid use in mild to moderate acne and rosacea is based on moderate certainty evidence from recent studies, including those published in 2024 1.
• These studies support the efficacy and safety of azelaic acid in improving symptoms of acne and rosacea, with a favorable side effect profile.

From the FDA Drug Label

After the skin is thoroughly washed and patted dry, a thin film of AZELEX® Cream should be gently but thoroughly massaged into the affected areas twice daily, in the morning and evening. The duration of use of AZELEX® Cream can vary from person to person and depends on the severity of the acne. Improvement of the condition occurs in the majority of patients with inflammatory lesions within four weeks. AZELEX® Cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.

The recommended treatment regimen for mild to moderate acne using azelaic acid is to apply a thin film of the cream to the affected areas twice daily, in the morning and evening. For rosacea, there is no direct information in the provided drug labels. 2 2

From the Research

Treatment Regimen for Mild to Moderate Acne and Rosacea using Azelaic Acid

• The recommended treatment regimen for mild to moderate acne and rosacea using azelaic acid is a topical application of 15% gel, as approved by the FDA in 2002 3.
• Azelaic acid 15% gel has been shown to be effective and safe in the treatment of inflammatory papulo-pustular rosacea, with high efficacy and minimal local irritation 3.
• Commercially available topical formulations of azelaic acid contain 5% to 20% azelaic acid in the form of gels and creams, and are well tolerated with limited side effects 4.
• A systematic review of 43 RCTs found that azelaic acid is more effective than vehicle for improving erythema severity, inflammatory lesion counts, and overall improvement in rosacea, and is also effective in reducing acne severity and improving global assessments in acne vulgaris 5.
• A double-blind, randomized clinical trial found that 20% azelaic acid gel is effective in reducing total lesion count and acne severity index in mild to moderate acne vulgaris, with a reduction of 60.6% and 65.2% respectively 6.
• Azelaic acid can be used as a topical treatment for rosacea, either alone or in combination with other treatments, and has been shown to be effective in reducing symptoms and improving quality of life 7.

Dosage and Application

• The recommended dosage of azelaic acid for mild to moderate acne and rosacea is 15% gel, applied topically twice a day 3.
• Azelaic acid can be applied to all skin types, and is suitable for long-term use 3.
• The use of liposomal technology has enabled the development of formulations with improved pharmacokinetics and pharmacodynamics, allowing for greater control over the delivery of azelaic acid to the skin 4.

Safety and Efficacy

• Azelaic acid has been shown to be safe and well tolerated, with minimal local irritation and no significant differences in adverse events compared to vehicle 5.
• Azelaic acid has anti-inflammatory, antioxidant, and antimicrobial properties, making it an effective treatment for acne and rosacea 4.
• Azelaic acid has also been shown to be effective in reducing hyperpigmentation and improving skin texture, making it a useful treatment for melasma and post-inflammatory hyperpigmentation 4.