Azelaic acid for rosacea: what the trials show

Azelaic acid is one of the main creams dermatologists use for rosacea, the long-term skin condition that causes facial redness, flushing and acne-like bumps. The FDA has approved azelaic acid 15% gel and 15% foam "for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea." In plain words, that means the red bumps and the small bumps with pus. The American Academy of Dermatology (AAD) says it "can effectively treat acne-like breakouts and may reduce long-lasting color." This guide covers what the trials found, what it does for redness, and how to use it. For an overview of the ingredient, see what azelaic acid is.

Rosacea is a medical condition, and a doctor needs to confirm it. The AAD says a dermatologist diagnoses it "by examining your skin and eyes," and sometimes needs tests to rule out conditions such as lupus that also color the face. If you are not sure whether you have rosacea or acne, read rosacea vs acne and see a doctor.

What the labels approve

Two FDA labels cover azelaic acid for rosacea:

Product	What the label approves it for	How often
Azelaic acid 15% gel	Red bumps and pus bumps of mild to moderate rosacea	Twice a day, morning and evening
Azelaic acid 15% foam	Red bumps and pus bumps of mild to moderate rosacea	Twice a day, to the whole face

Both labels are filed on DailyMed as prescription drug labels. The gel label adds a limit: "efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated." Erythema is the medical word for redness. So the approval covers rosacea with bumps. MedlinePlus, the U.S. National Library of Medicine's drug guide, says azelaic acid "works to treat rosacea by decreasing the swelling and redness of the skin."

The gel label also says "the mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown." A 2024 review in Clinical, Cosmetic and Investigational Dermatology describes lab findings: azelaic acid blocked several signals in skin cells that drive the inflammation of rosacea. Those are lab results, and the label's statement still stands.

What the trials found

The gel. The label reports two 12-week trials with 664 adults aged 21 to 86. People had mild to moderate rosacea with an average of 18 bumps. Half used the gel twice a day and half used the same gel without the medicine.

Trial	Bumps at the start	Bumps at 12 weeks	Drop	Rated clear, minimal or mild
Study one, azelaic acid gel	17.5	6.8	57.9%	61%
Study one, gel without medicine	17.6	10.5	39.9%	40%
Study two, azelaic acid gel	17.9	9.0	50.0%	61%
Study two, gel without medicine	18.5	12.1	38.2%	48%

The same trials, published in the Journal of the American Academy of Dermatology in 2003, also report that more people on the gel had better redness: 44% against 29% in study one, and 46% against 28% in study two.

The foam. Two 12-week trials with 1,362 adults found success, meaning skin rated clear or almost clear, in 32.1% and 43.4% of foam users, against 23.4% and 32.5% for the foam without the medicine.

The reviews. A 2015 Cochrane review, which pools every trial on a question and grades how far the results can be trusted, rated the evidence for azelaic acid in rosacea as high quality. Its 2019 update in the British Journal of Dermatology counted six trials in which 648 of 1,132 people rated their improvement as marked or excellent with azelaic acid, against 439 of 1,091 with the product without the medicine.

The results show a steady benefit. They also show the product without the medicine helped many people. In the gel trials, everyone was also told to use mild cleansers and to avoid spicy food, hot drinks and alcohol.

Redness, flushing and visible blood vessels

Rosacea has several signs, and azelaic acid helps some more than others.

• Bumps. This is the use the labels approve, and the evidence is strongest here.
• Redness that comes with the bumps. The 2019 review found azelaic acid reduced redness by a small amount. The AAD says it "may reduce long-lasting color."
• Redness without bumps. The gel label says this has not been evaluated.
• Visible blood vessels. A 2006 review of five trials in Archives of Dermatology found that none showed a decrease in visible blood vessels. A 15-week trial against metronidazole gel reported that neither treatment had a clear effect on them.

For lasting redness and flushing, the AAD lists other options: brimonidine gel or oxymetazoline cream, which "can fade the persistent color for up to 12 hours," and laser or light treatments for redness and blood vessels. The guide on how to treat rosacea covers each one.

How to use it

The gel and foam labels give these steps:

1. Wash with a mild soap or a soapless cleansing lotion, and pat dry with a soft towel.
2. Apply a thin layer to the affected areas twice a day. The foam label says to cover the whole face: cheeks, chin, forehead and nose. Shake the foam first.
3. Wash your hands right after.
4. Put on makeup only after the product has dried.
5. Do not cover the skin with a bandage or wrap.

The labels also say to avoid alcohol-based cleansers and tinctures, astringents, abrasive scrubs and peeling products. The foam contains a propellant that can catch fire, so keep it away from flames and do not smoke while applying it.

A 2008 study in the Journal of Drugs in Dermatology compared once-daily and twice-daily 15% gel in 92 people for 12 weeks and found no difference in results. Follow your prescriber's schedule, and ask before you change it.

People in the trials were asked to avoid spicy food, hot drinks and alcohol. MedlinePlus gives the same advice for people with rosacea: avoid foods and drinks that make you flush. Gentle skin care matters too. The AAD says a rosacea plan includes "a gentle cleanser, moisturizer, and sunscreen." The guide to skincare for rosacea walks through a routine.

Side effects

The gel label lists these reactions from its U.S. trials: burning, stinging or tingling in 29% of users, itching in 11%, dry or scaly skin in 8%, and redness or irritation in 4%. It says skin irritation usually happens "during the first few weeks of treatment." The foam label reports skin pain, a term that covers burning and stinging, in 6.2% of users, against 1.5% with the foam without the medicine.

The labels also warn about:

• Eyes. Azelaic acid can irritate the eyes. If it gets in, rinse with plenty of water and see a doctor if irritation continues.
• Asthma. Worsening asthma has been reported. Tell a doctor if it happens.
• Allergic reactions. Swelling of the face or eyes, hives or trouble breathing need urgent care.
• Light patches. There have been isolated reports of skin lightening, and the labels ask people with darker skin to watch for early signs.

The gel, cream or serum guide compares how often each form caused stinging in its trials.

How long it takes

A 2015 Cochrane review says improvements with azelaic acid and metronidazole "tended to appear after three to six weeks." The gel label says to "reassess the diagnosis if no improvement is observed upon completing 12 weeks of therapy," and the foam label says to use it "continuously over 12 weeks." In a 15-week trial of 251 people published in Archives of Dermatology, azelaic acid gel kept improving through week 15, while metronidazole gel leveled off after week 8. The before and after guide sets out the timelines for every condition.

Keeping rosacea under control

Rosacea comes and goes. NIAMS, part of the U.S. National Institutes of Health, says "there is no cure for rosacea, but there are ways to make your skin look and feel better." The 2019 review found that topical metronidazole, ivermectin and azelaic acid 15% gel "seem effective and safe as maintenance treatments," meaning they help keep bumps from returning after they clear. Your dermatologist decides how long to continue.

What about store-bought azelaic acid?

Products sold without a prescription typically contain less azelaic acid and often mix it with other ingredients, according to the 2024 review. The 2024 review lists an 8-week study of 30 people with mild to moderate rosacea who used a cream with 10% azelaic acid and two other ingredients. Bump counts fell, but the study had no comparison group, so it cannot show how much came from the cream. The trials behind the FDA approval used 15%. The strengths guide compares what is known at each strength.

When to see a doctor

See a doctor if you think you have rosacea, if bumps or redness keep coming back, or if your skin is thickening. The NHS advises an urgent appointment if you have rosacea and an eye becomes painful, red, gritty or sensitive to light, or your vision blurs. The 15% gel and foam need a prescription, and a dermatologist can combine azelaic acid with other treatments. Some people get a rash around the mouth called perioral dermatitis, which the AAD says often looks like acne. The guide to azelaic acid for perioral dermatitis covers that condition. Skinli gives general education. A doctor is the right person to diagnose and treat your skin.