Topical Azelaic Acid (10–20%)

Purpose & Scope

This policy explains how our clinic initiates and monitors topical azelaic acid at 10–20% for acne vulgaris, papulopustular rosacea, and pigmentary change such as post‑inflammatory hyperpigmentation and melasma. ⁶ ⁸ It is written in plain language so clinicians and support staff can give consistent, safe instructions that align with Australian regulators and mainstream dermatology guidance. ¹ ⁴ Where brand examples are given, they reflect current Australian registrations and consumer‑facing information to aid counselling at point of supply. ¹ ¹⁵

What is Azelaic Acid and How Does It Work?

Azelaic acid is a naturally occurring dicarboxylic acid used on the skin to calm inflammation, normalise pore shedding, reduce bacteria in acne, and slow excess pigment production via tyrosinase inhibition. ⁶ ⁷ These actions make it useful across three common problems seen in cosmetic practice: acne lesions, rosacea papules and background redness, and blotchy brown marks from melasma or previous acne. ⁶ ⁸ It is generally well tolerated, does not bleach normal skin, and is not notably photosensitising, which allows daytime use with sunscreen. ⁶

Preparations in Australia (10–20%) and Regulatory Points

In Australia, azelaic acid 15% gel is registered on the Australian Register of Therapeutic Goods as a Schedule 2 Pharmacy Medicine and is indicated for mild to moderate acne and papulopustular rosacea. ¹ ³ Azelaic acid 20% is available locally as a medicated lotion under Azclear Action, also recorded on the ARTG as a non‑prescription pharmacy medicine. ² ¹⁵ This policy also recognises 10% cosmetic serums used by patients, but notes that such cosmetic products are not equivalent to registered medicines for claims of treating acne or rosacea. ⁶ ⁸

Before You Start (Selection, Baselines, Compatibility)

Choose azelaic acid when a gentle, pigment‑friendly, pregnancy‑compatible option is preferred, or when a patient has struggled with irritation from benzoyl peroxide or retinoids. ⁶ ¹² It suits adult‑female acne, skin of colour at risk of post‑inflammatory hyperpigmentation, and rosacea with inflammatory bumps. ⁶ ⁸ Record baseline photos in good light, document current skincare, and ask about stinging with acids or peels to anticipate tolerance. ⁶ Explain realistic timelines up‑front so patients do not abandon therapy early. ¹⁴ ⁹

How to Apply (Clear, Stepwise)

Cleanse with a mild, non‑soap cleanser and pat the skin completely dry before each application. ⁶ ¹⁴ Apply a thin film to the whole affected area rather than just individual spots to treat both visible and early lesions. ⁶ ⁷ For the face, the usual amount is about 0.5 g, which is roughly a 2.5 cm strip from the tube, spread as a very thin layer. ¹⁴ Start once daily for three or four days if the skin is sensitive, and then increase to twice daily as tolerated. ¹⁴ ⁶ Avoid the eyes, lips, corners of the nose, and any broken or freshly shaved skin, and wash hands after use. ¹⁴ ⁶ Use a non‑comedogenic moisturiser if any tightness or dryness appears, and add a broad‑spectrum SPF 50+ every morning. ⁶ ⁴

What to Expect (Timelines and Outcomes)

For acne, most people see less redness and fewer new lesions within four to eight weeks, with best results emerging after several months of regular use. ¹⁴ ⁷ For rosacea, clinical trials and practice experience support steady improvement over about eight to twelve weeks, with reductions in inflammatory bumps and background erythema. ⁹ ¹⁰ For melasma and post‑inflammatory hyperpigmentation, skin tone usually evens gradually over two to four months and requires strict daily photoprotection to hold results. ¹⁶ ¹⁷

Evidence Summary (Readable Version)

Two large phase‑III trials show azelaic acid 15% gel beats vehicle for papulopustular rosacea and improves both lesion counts and erythema. ⁹ A head‑to‑head trial found azelaic acid 15% gel performed at least as well as 0.75% metronidazole gel over fifteen weeks with good tolerability. ¹⁰ ⁵ A foam 15% formulation has also shown benefit versus vehicle, supporting a class effect across approved vehicles. ¹¹ Guidelines for acne include azelaic acid as a useful monotherapy or add‑on when retinoids or benzoyl peroxide are not tolerated or when dyschromia is a priority. ⁸ ⁷ Randomised studies in melasma demonstrate that azelaic acid 20% performs comparably to hydroquinone 4% in many outcomes, and reviews rate the evidence as favourable when combined with sun protection. ¹⁶ ¹⁷

Combinations and Regimens

For acne, combine azelaic acid with a retinoid at night or benzoyl peroxide in the morning to target multiple pathways while avoiding unnecessary topical antibiotics. ⁸ ⁷ For rosacea, pair with a gentle anti‑inflammatory topical such as metronidazole or ivermectin when monotherapy is not enough, adding trigger control and sunscreen. ⁵ ⁴ If irritation occurs with combinations, space the products morning and night or alternate days until the skin adapts. ¹⁴ ⁶

Safety, Tolerability, Pregnancy and Lactation

The main side effects are transient stinging, burning, itching, redness, dryness and mild scaling, which are usually most noticeable in the first weeks. ¹⁴ ⁶ Reduce frequency or pause for a few days if the skin becomes sore, then restart at a lower frequency and moisturise daily. ¹⁴ ⁶ Hypersensitivity to azelaic acid or excipients such as propylene glycol is a contraindication, and patients should stop and seek advice if marked swelling or rash occurs. ¹⁴ ⁶ Systemic absorption from topical azelaic acid is very limited, which underpins its favourable safety profile. ¹⁴ Australian hospital guidance lists azelaic acid as TGA category B1 in pregnancy and compatible with breastfeeding, and LactMed supports low risk to the nursing infant. ¹² ¹³

Patient Counselling that Sticks

Keep the routine simple: cleanse, azelaic acid, moisturiser, and sunscreen in the morning; cleanse, azelaic acid, and moisturiser at night. ⁶ ¹⁴ Use fragrance‑free products and avoid scrubs, alcohol‑heavy toners, or strong peels during the first few weeks. ⁶ For rosacea, minimise known triggers such as heat, hot drinks, alcohol and spicy food, and protect from sun and wind exposure. ⁴ ⁵ Set expectations: results are gradual, so stick with the plan and do not judge effectiveness in the first two weeks. ¹⁴ ⁹

Monitoring and Escalation

Review adherence and technique at eight to twelve weeks and check for irritant dermatitis or photosensitivity. ⁸ ⁴ If acne control is suboptimal, consider adding or switching to a retinoid, benzoyl peroxide combination, or other guideline‑supported options, and limit antibiotics to clear indications and durations. ⁸ ⁷ If rosacea control is inadequate, consider metronidazole, ivermectin, brimonidine or oxymetazoline for erythema, or low‑dose doxycycline in persistent inflammatory disease. ⁵ ⁴

Storage, Handling and Supply

Store below 30 °C and keep tubes out of direct heat or sun, and advise external use only. ¹⁴ Azelaic acid 15% gel and 20% lotion are non‑prescription pharmacy medicines in Australia, so counselling at the point of supply is important. ¹ ²

Quick‑Reference Instructions for Patients

Wash with a gentle cleanser and wait five to ten minutes until fully dry. ⁶ ¹⁴ Apply a pea‑sized amount or a 2.5 cm strip spread very thinly over the whole affected area. ¹⁴ Start once daily for several days, then build to twice daily as comfort allows. ¹⁴ ⁶ Moisturise after each application and use SPF 50+ every morning. ⁶ ⁴ Expect gradual improvement over weeks, not days, and keep photos to track progress. ¹⁴ ⁹

Sources

Therapeutic Goods Administration (TGA) 2025, Public Summary for ARTG Entry: 97747 — FINACEA azelaic acid 150 mg/g gel (PDF), Department of Health and Aged Care, viewed 11 Nov 2025., viewed 20 November 2025, https://www.ebs.tga.gov.au/servlet/xmlmillr6?actionid=1&agid=(PrintDetailsPublic)&dbid=ebs/PublicHTML/pdfStore.nsf&docid=97747 ↩
Therapeutic Goods Administration (TGA) 2025, Public Summary for ARTG Entry: 71006 — AZCLEAR ACTION azelaic acid 200 mg/g medicated lotion (PDF), Department of Health and Aged Care, viewed 11 Nov 2025., viewed 20 November 2025, https://www.ebs.tga.gov.au/servlet/xmlmillr6?actionid=1&agid=(PrintDetailsPublic)&dbid=ebs/PublicHTML/pdfStore.nsf&docid=71006 ↩
Healthdirect 2025, Finacea — medicine brand entry (ARTG‑derived), viewed 11 Nov 2025., viewed 20 November 2025, https://www.healthdirect.gov.au/medicines/brand/amt,53281011000036102/finacea ↩
RACGP 2017, Rosacea, Australian Family Physician — diagnosis, triggers and topical options, viewed 11 Nov 2025., viewed 20 November 2025, https://www.racgp.org.au/afp/2017/may/rosacea ↩
Australian Prescriber 2018, An update on the treatment of rosacea, viewed 11 Nov 2025., viewed 20 November 2025, https://australianprescriber.tg.org.au/articles/an-update-on-the-treatment-of-rosacea.html ↩
DermNet NZ 2023, Azelaic acid — uses, application and safety, viewed 11 Nov 2025., viewed 20 November 2025, https://dermnetnz.org/topics/azelaic-acid ↩
DermNet NZ 2024, Topical therapy for acne (CME) — azelaic acid dosing and tolerability, viewed 11 Nov 2025., viewed 20 November 2025, https://dermnetnz.org/cme/follicular/topical-therapy-for-acne ↩
NICE 2023 (NG198), Acne vulgaris: management — recommendations including azelaic acid, viewed 11 Nov 2025., viewed 20 November 2025, https://www.nice.org.uk/guidance/ng198 ↩
Thiboutot D et al. 2003, Efficacy and safety of azelaic acid (15%) gel in papulopustular rosacea: two phase III RCTs, Journal of the American Academy of Dermatology 48(6):836–845 (PubMed), viewed 11 Nov 2025., viewed 20 November 2025, https://pubmed.ncbi.nlm.nih.gov/12789172/ ↩
Elewski BE et al. 2003, 15% azelaic acid gel vs 0.75% metronidazole gel in rosacea: randomized trial, Arch Dermatol 139(11):1444–1450 (JAMA Dermatology), viewed 11 Nov 2025., viewed 20 November 2025, https://jamanetwork.com/journals/jamadermatology/fullarticle/479570 ↩
Draelos ZD et al. 2015, Azelaic acid foam 15% in papulopustular rosacea: phase 3 randomized, double‑blind, vehicle‑controlled trial, Journal of Drugs in Dermatology (PubMed), viewed 11 Nov 2025., viewed 20 November 2025, https://pubmed.ncbi.nlm.nih.gov/26244354/ ↩
Fiona Stanley Hospital (WA Health) 2025, Dermatology pre‑referral guideline — acne (B1 pregnancy category; breastfeeding compatible), viewed 11 Nov 2025., viewed 20 November 2025, https://fsfhg.health.wa.gov.au/~/media/HSPs/SMHS/Hospitals/FSFHG/Files/PDF/FSH-Derma-acne-guidelines.pdf ↩
LactMed (NIH/NLM) 2024, Azelaic Acid — Drugs and Lactation Database, viewed 11 Nov 2025., viewed 20 November 2025, https://www.ncbi.nlm.nih.gov/books/n/lactmed/LM541/ ↩
NPS MedicineWise 2020, Finacea Consumer Medicine Information (MIMS PDF) — dosing (≈0.5 g) and storage (<30 °C), viewed 11 Nov 2025., viewed 20 November 2025, https://www.nps.org.au/assets/medicines/4e700633-9f20-43d3-86ad-a53300fed23e.pdf ↩
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Farshi S 2011, 20% azelaic acid vs hydroquinone 4% for melasma: randomized trial, Journal of Cosmetic Dermatology (PubMed), viewed 11 Nov 2025., viewed 20 November 2025, https://pubmed.ncbi.nlm.nih.gov/22151936/ ↩
Sarma N et al. 2017, Evidence‑based review and consensus for medical management of melasma — Grade‑A for azelaic acid 20% cream, Indian Journal of Dermatology (PMC), viewed 11 Nov 2025., viewed 20 November 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC5707834/ ↩

Disclaimer for Newcastle Cosmetic Doctor Policies & Procedures

The policies and procedures contained within this document are the exclusive property of Newcastle Cosmetic Doctor and are provided for internal clinical governance and educational purposes only. These materials represent the internal operational framework, safety standards, and evidence-based protocols developed and implemented by Dr. Bart John Scanlon and the Newcastle Cosmetic Doctor team. They are designed specifically for use within Newcastle Cosmetic Doctor and reflect our clinic’s own professional standards, risk assessments, and compliance obligations under Australian law and regulatory authorities. External individuals, practitioners, or organisations must not copy, reproduce, distribute, or rely upon these materials, in whole or in part, for their own clinical, commercial, or educational use without prior written consent from Newcastle Cosmetic Doctor. These materials do not constitute medical, legal, or professional advice and are not intended to be adopted as official protocols or procedures by any other entity. Any external use or adaptation must be independently reviewed and modified to meet the relevant laws, guidelines, and standards applicable to the user’s own jurisdiction, scope of practice, and facility operations. Newcastle Cosmetic Doctor and Dr. Bart Scanlon accept no liability for any loss, injury, or damage arising from the unauthorised use, reliance upon, or misinterpretation of this material.