In this article
Redness that will not settle, small bumps across the cheeks, and patches of darker skin are common complaints in midlife. Azelaic acid and niacinamide are two ingredients often used for them, sometimes together in one cream. This guide separates what each one is approved for, what the trials actually measured, and where the evidence is thin.
What azelaic acid is
Azelaic acid is a naturally occurring acid found in whole grains and animal products, and the body makes small amounts of it too [2]. As a prescription it comes in two FDA-approved forms. The 15% gel is indicated for the inflammatory papules and pustules (bumps and pimples) of mild to moderate rosacea [1]. The 20% cream is indicated for mild to moderate inflammatory acne [2].
How it works in rosacea is not known [1]. In lab studies it has antibacterial activity against acne bacteria and may normalize how skin cells shed in pores, though the clinical meaning of those findings is unknown [2]. Very little reaches the bloodstream. About 4% of the 20% cream is absorbed through the skin [2], and blood levels with the 15% gel stayed within the range seen from diet and the body's own production [1].
Azelaic acid for rosacea
The 15% gel was approved on the strength of two identical 12-week trials in 664 adults with mild to moderate papulopustular rosacea [1]. Their average age was 49, and 73% were women [1]. People applied the gel or a plain gel twice a day.
| Trial | Azelaic acid 15% gel | Plain gel |
|---|---|---|
| Study one: average reduction | 57.9% | 39.9% |
| Study two: average reduction | 50.0% | 38.2% |
| Average count at start | 17.5 to 17.9 lesions | 17.6 to 18.5 lesions |
Both trials showed azelaic acid worked better than the plain gel for bump and pimple counts and on the doctors' overall rating [1]. Notice that the plain gel helped too, which is common in skin trials. A 2023 systematic review of 20 rosacea trials found azelaic acid improved redness severity, lesion counts, and overall improvement compared with vehicle after 12 weeks [3].
One limit matters if your rosacea is mainly flushing and redness. The label says some redness improved in people who had bumps and pimples, but its effect on redness in rosacea without bumps and pimples has not been evaluated [1]. The label also advises reassessing the diagnosis if there is no improvement after 12 weeks [1].
Azelaic acid for dark spots and melasma
Azelaic acid is not FDA-approved for melasma (patchy darkening of the skin) or other dark spots, but it has been tested. In the 2023 systematic review, seven melasma trials found 20% azelaic acid worked better than a plain cream for severity and overall improvement, and better than 2% hydroquinone for overall improvement [3]. A separate meta-analysis of six randomized trials with 673 patients compared azelaic acid with hydroquinone and found a somewhat greater drop in a melasma severity score with azelaic acid, with similar side effects [4]. Its authors called for larger, longer studies [4].
Most of those melasma trials used the 20% strength [3], higher than the 15% in many products. And the systematic review found no randomized trials of azelaic acid for skin aging [3]. Sun protection belongs in any plan for dark spots: in the niacinamide melasma trial described below, everyone used sunscreen throughout [7]. The FDA advises broad spectrum sunscreen of SPF 15 or higher, reapplied at least every two hours outdoors [9].
What niacinamide adds
Niacinamide is a form of vitamin B3 used widely in skin care. Its evidence comes mostly from small trials, several run by researchers at a skin care manufacturer.
- Aging skin: In a 12-week split-face trial of 50 women aged 40 to 60, a moisturizer with 5% niacinamide improved fine lines, brown spots, texture, red blotchiness, and sallowness more than the same moisturizer without it [5]. A similar 50-person trial reported improved elasticity as well [6]. Both were run by Procter & Gamble researchers.
- Melasma: In an eight-week trial in 27 patients, 4% niacinamide on one side of the face and 4% hydroquinone on the other both lightened pigment. Good to excellent improvement was seen in 44% with niacinamide and 55% with hydroquinone, and side effects occurred in 18% and 29% [7].
These are encouraging but small studies. Niacinamide is not an FDA-approved drug for rosacea or melasma.
Side effects and who should be careful
Azelaic acid commonly stings. Across the rosacea trials, the most common treatment-related effects were burning, stinging, or tingling (29%), itching (11%), scaling or dryness (8%), and redness or irritation (4%) [1]. Irritation usually happens in the first few weeks [1].
- Reported ~29%
- Not reported ~71%
- Reported ~11%
- Not reported ~89%
- Reported ~8%
- Not reported ~92%
Treatment-related events in US rosacea trials, from the azelaic acid 15% gel prescribing information [1].
- Darker skin: Isolated cases of lightened skin (hypopigmentation) have been reported, and the label advises watching for early signs if you have a dark complexion [1, 2].
- Asthma: Worsening of asthma has been reported; tell your clinician if your asthma flares [1].
- Eyes: Keep it away from your eyes and mouth; it can irritate the eyes [1].
- Allergy: Swelling of the face or eyes, hives, or trouble breathing have been reported; stop and seek care if they occur [1].
- Pregnancy and breastfeeding: Azelaic acid is minimally absorbed and is not expected to expose a fetus [1]. Tell your clinician if you are pregnant or breastfeeding.
Azelaic acid + niacinamide through WarriorBabe Health
WarriorBabe Health offers an azelaic acid + niacinamide cream with 15% azelaic acid and 4% niacinamide, applied once daily in the morning. The evidence in this article comes from studies of each ingredient on its own; the combination in a single cream has not been tested the same way.
The cream is compounded by a licensed pharmacy and is not FDA-approved. The FDA does not verify the safety, effectiveness, or quality of compounded drugs before they are marketed [8]. Its product information lists burning, stinging, tingling, and local irritation as common side effects, and says not to use it on broken, damaged, or irritated skin.
Redness and dark patches have several causes, and some need a different treatment, so a clinician should look at your skin history first. You can compare all options on our skin treatments page, read about menopause skin changes, or take the 2-minute quiz so a licensed clinician can review whether a prescription is appropriate.
Frequently asked questions
Is azelaic acid good for rosacea?
Azelaic acid 15% gel is FDA-approved for the bumps and pimples of mild to moderate rosacea [1]. In two 12-week trials it reduced lesion counts by 50 to 58%, versus 38 to 40% with a plain gel [1]. Its effect on redness without bumps has not been evaluated [1].
Does azelaic acid fade dark spots?
It is not FDA-approved for dark spots, but in randomized trials for melasma, 20% azelaic acid did better than a plain cream and about as well as or better than hydroquinone [3, 4]. Pair it with daily broad spectrum sunscreen of SPF 15 or higher, as the FDA advises [9].
Can you use azelaic acid and niacinamide together?
They are often combined, and each has its own evidence: azelaic acid for rosacea, acne, and melasma [1, 3], niacinamide for brown spots and redness in small trials [5, 7]. The two together in one cream have not been tested in the trials cited here, so ask your clinician whether the combination fits your skin.
Why does azelaic acid sting?
Burning, stinging, or tingling was the most common reaction in rosacea trials, reported by 29% of patients [1]. The 20% cream's label links it partly to azelaic acid's low pH and says it usually eases as treatment continues [2]. Tell your clinician if it persists or becomes severe [1].
Is azelaic acid safe during pregnancy?
The 15% gel's label says azelaic acid is minimally absorbed and maternal use is not expected to expose the fetus [1]. Still, tell your clinician if you are pregnant or breastfeeding before starting any prescription cream, including a compounded one.
References
- Encube Ethicals. Azelaic acid gel, 15% prescribing information. DailyMed, US National Library of Medicine. Revised 3/2023. dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab3f174c-a3c4-4ae9-b0bc-954efaadf8de
- Almirall. Azelex (azelaic acid cream) 20% prescribing information. DailyMed, US National Library of Medicine. Revised 2/2024. dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebdfcaf7-b5d6-47e1-be87-ccaba4b97e75
- King S, Campbell J, Rowe R, et al. A systematic review to evaluate the efficacy of azelaic acid in the management of acne, rosacea, melasma and skin aging. J Cosmet Dermatol. 2023;22(10):2650-2662. pubmed.ncbi.nlm.nih.gov/37550898/
- Albzea W, AlRashidi R, Alkandari D, et al. Azelaic acid versus hydroquinone for managing patients with melasma: systematic review and meta-analysis of randomized controlled trials. Cureus. 2023;15(7):e41796. pmc.ncbi.nlm.nih.gov/articles/PMC10339666/
- Bissett DL, Miyamoto K, Sun P, et al. Topical niacinamide reduces yellowing, wrinkling, red blotchiness, and hyperpigmented spots in aging facial skin. Int J Cosmet Sci. 2004;26(5):231-238. pubmed.ncbi.nlm.nih.gov/18492135/
- Bissett DL, Oblong JE, Berge CA. Niacinamide: a B vitamin that improves aging facial skin appearance. Dermatol Surg. 2005;31(7 Pt 2):860-865. pubmed.ncbi.nlm.nih.gov/16029679/
- Navarrete-Solís J, Castanedo-Cázares JP, Torres-Álvarez B, et al. A double-blind, randomized clinical trial of niacinamide 4% versus hydroquinone 4% in the treatment of melasma. Dermatol Res Pract. 2011;2011:379173. pmc.ncbi.nlm.nih.gov/articles/PMC3142702/
- US Food and Drug Administration. Understanding the risks of compounded drugs. www.fda.gov/drugs/human-drug-compounding/understanding-risks-compounded-drugs
- US Food and Drug Administration. Sunscreen: how to help protect your skin from the sun. 2026. www.fda.gov/drugs/understanding-over-counter-medicines/sunscreen-how-help-protect-your-skin-sun
This article is for general information. It is not medical advice and does not replace a visit with a licensed clinician who knows your history. Do not start, stop or change a medication without talking to your clinician. If you think you are having a medical emergency, call 911.
