What is the recommended treatment protocol for acne using azelaic acid gel?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: July 1, 2025View editorial policy

Personalize

Help us tailor your experience

Which best describes you? Your choice helps us use language that's most understandable for you.

From the Guidelines

The recommended treatment protocol for acne using azelaic acid gel involves applying a thin layer of 20% azelaic acid gel to clean, dry skin twice daily, in the morning and evening, as it is mildly effective as a comedolytic, antibacterial, and anti-inflammatory agent 1.

Key Considerations

  • Azelaic acid is particularly useful for patients with sensitive skin or of Fitzpatrick skin types IV or greater due to its lightening effect on dyspigmentation 1.
  • It is recommended to start with once-daily application for the first week to minimize irritation, then increase to twice daily if tolerated well.
  • Patients should gently massage the gel into affected areas, avoiding contact with eyes, mouth, and mucous membranes.
  • Most patients should continue treatment for at least 12 weeks to see optimal results, as improvement typically begins after 4 weeks but full benefits may take longer.
  • Azelaic acid works by reducing inflammation, killing acne-causing bacteria (P. acnes), and normalizing follicular hyperkeratinization that leads to clogged pores.
  • It's particularly effective for mild to moderate inflammatory acne and can help reduce post-inflammatory hyperpigmentation.
  • Patients should use sunscreen during daytime as skin may be more sensitive to UV radiation.
  • Common side effects include mild burning, stinging, or redness upon application, which typically diminish with continued use.
  • If severe irritation occurs, reducing application frequency or discontinuing temporarily may help.

Additional Recommendations

  • According to the most recent guidelines, azelaic acid is conditionally recommended for the treatment of acne 1.
  • Combining topical therapies with multiple mechanisms of action is recommended as a good practice statement 1.
  • Limiting systemic antibiotic use and combining systemic antibiotics with topical therapies are also recommended as good practice statements 1.

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 recommended treatment protocol for acne using azelaic acid gel is to apply a thin film to the affected areas twice daily, in the morning and evening 2.

  • Key points:
    • Apply after washing and drying the skin
    • Massage gently into affected areas
    • Wash hands after application Note that the provided information refers to azelaic acid cream, not gel, but it is assumed that the treatment protocol may be similar 2.

From the Research

Azelaic Acid Gel for Acne Treatment

The recommended treatment protocol for acne using azelaic acid gel is as follows:

  • Apply azelaic acid 15% gel twice daily to affected areas 3, 4
  • The treatment can be used as monotherapy or in combination with other agents 3
  • Azelaic acid 15% gel has been shown to be effective in reducing inflammatory papules and pustules, with a median reduction of 70-71% 3, 4
  • The gel is well-tolerated, with local irritation (burning, stinging, itching, and scaling) being typically mild and transient 5

Efficacy and Safety

  • Azelaic acid 15% gel has been compared to other topical treatments, such as benzoyl peroxide 5% and clindamycin 1%, and has been shown to be as effective 3, 4
  • The gel has also been shown to be effective in maintaining treatment response over a 6-month period 6
  • Azelaic acid 15% foam has also been shown to be effective in treating moderate truncal acne and facial acne 7

Patient Satisfaction

  • Patients have reported high satisfaction with azelaic acid 15% gel, with 74% of patients being "very satisfied" at the end of therapy 3
  • The majority of patients were more satisfied with azelaic acid 15% gel than with previous therapies 3

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

[Azelaic acid 15% gel in the treatment of acne vulgaris. Combined results of two double-blind clinical comparative studies].

Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG, 2004

Research

Azelaic acid (15% gel) in the treatment of acne rosacea.

International journal of dermatology, 2007

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.