Topical anti-acne / anti-rosacea Pregnancy: No adequate and well-controlled studies of topical azelaic acid in pregnant women; animal studies indicate potential effects on pregnancy and embryo-fetal development — caution should be exercised when prescribing to pregnant women. Lactation: passage into maternal milk may occur but is not expected to change baseline levels significantly (less than 4% systemically absorbed); caution when used in a nursing woman and infants must not come into contact with treated skin/breast.

Azelaic acid

Brand names: Skinoren (cream 20%), Finacea (gel 15%)

Azelaic acid is a topical dicarboxylic acid used for mild-to-moderate acne and for the papulopustular lesions of rosacea.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Apply 15% gel to the affected skin areas and rub in gently; approximately 0.5 g (a 2.5 cm / 1 inch length of gel) is sufficient for the entire facial area

Route: Topical — cutaneous use only

Frequency: Twice a day (morning and evening)

Source SPC is Finacea 15% Gel (acne vulgaris and papulopustular rosacea). Method: clean the skin thoroughly with plain water and dry before application (a mild skin-cleansing agent may be used); do not use occlusive dressings or wrappings; wash hands after applying. If skin irritation occurs, reduce the amount of gel per application or reduce the frequency to once a day until the irritation ceases, and if required interrupt treatment for a few days. It is important to use the gel continuously over the entire period of treatment; duration varies with the individual and severity. Acne: distinct improvement generally apparent after 4 weeks; may be used over several months for optimum results; discontinue and consider other options if there is no improvement after 1 month or the acne worsens. Rosacea: distinct improvement generally apparent after 4 weeks; may be used over several months; discontinue and consider other options if there is no improvement after 2 months or the rosacea worsens. Paediatric: licensed in adolescents 12-18 years for acne vulgaris with no dose adjustment required; safety and efficacy not established for acne vulgaris below 12 years, or for papulopustular rosacea below 18 years. Elderly: no targeted studies in patients aged 65 and over. Hepatic impairment: no targeted studies performed.

Dose adjustments

Renal

No targeted studies have been performed in patients with renal impairment.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients

Side effects

Application site burning, application site pain and application site pruritus — the most frequently observed effects
Application site rash, paraesthesia, dryness, oedema, erythema, exfoliation, warmth, discolouration, discomfort or urticaria
Contact dermatitis and acne
Skin irritation and urticaria (uncommon/rare)
Hypersensitivity — may present with angioedema, eye swelling, facial swelling or dyspnoea
Worsening of asthma — reported rarely in post-marketing surveillance

Interactions

No interaction studies have been performed; no drug-specific interactions were noted during the controlled clinical trials
Avoid other topical drugs and skin care products that could cause local irritation during treatment — soaps, alcoholic cleansers, tinctures, astringents, abrasives and peeling agents (SPC §4.4)

Clinical monograph

How it works

It has antimicrobial activity against Cutibacterium acnes, normalises keratinisation and reduces inflammation, with an additional effect on excess pigmentation.

Prescribing in practice

Transient burning, stinging and itching at the application site are common and patients should be warned to expect them.
Avoid contact with the eyes, mouth and other mucous membranes, washing with water if accidental contact occurs.
Benefit develops over several weeks of regular twice-daily use.

Monitoring

No laboratory monitoring is required; review skin response and tolerability clinically.

Counselling the patient

Apply to clean, dry skin and a mild tingling or stinging at first is normal.
Avoid getting the product in the eyes or mouth.
Continue regular use for several weeks before judging benefit.

Evidence & guidelines

Topical azelaic acid is recommended by NICE as an option in the management of acne and rosacea.

Reference: SmPC Skinoren / Finacea; NICE NG198 (Acne 2021); BAD Rosacea Guideline 2021; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways