Finacea: Uses, Dosage & Side Effects

What Is Finacea and What Is It Used For?

Finacea gel contains the active substance azelaic acid, a naturally occurring saturated dicarboxylic acid (nonanedioic acid) that is produced by the yeast Malassezia furfur on healthy human skin and is also found in certain cereal grains such as wheat, rye, and barley. When formulated as a 15% gel for topical application, azelaic acid exerts a combination of antimicrobial, anti-inflammatory, and antikeratinizing (comedolytic) effects that make it effective against both acne and rosacea.

Acne vulgaris is one of the most common skin conditions worldwide, affecting an estimated 85% of people between the ages of 12 and 24 at some point. It is characterized by the formation of comedones (blocked pores), papules (raised, inflamed bumps), and pustules (pus-filled lesions) on the face, and sometimes on the chest and back. The pathophysiology of acne involves four interrelated factors: excess sebum production, abnormal keratinization of the hair follicle (leading to blocked pores), colonization by the bacterium Cutibacterium acnes (formerly Propionibacterium acnes), and subsequent inflammation. Azelaic acid addresses several of these pathways simultaneously.

Rosacea is a chronic inflammatory skin condition primarily affecting the central face – the cheeks, nose, chin, and forehead. The papulopustular subtype of rosacea is characterized by persistent facial redness (erythema) along with inflammatory papules and pustules that can resemble acne but occur without comedones. Rosacea affects an estimated 5–10% of the population, with a higher prevalence among fair-skinned individuals and women, although men tend to develop more severe manifestations. The exact cause of rosacea is not fully understood, but it involves dysregulation of the innate immune system, neurovascular changes, and alterations in the skin microbiome. Elevated levels of the antimicrobial peptide cathelicidin (LL-37) and the protease kallikrein-5 (KLK5) in rosacea skin play a central role in driving inflammation.

The antimicrobial action of azelaic acid is mediated through several mechanisms. It inhibits thioredoxin reductase and other mitochondrial enzymes in aerobic microorganisms, disrupting their energy metabolism and reducing their ability to proliferate. Against Cutibacterium acnes, azelaic acid has been shown to reduce bacterial counts on the skin significantly within weeks of regular application. It is also effective against Staphylococcus epidermidis, another organism implicated in inflammatory skin conditions.

The anti-inflammatory properties of azelaic acid are particularly relevant for both acne and rosacea. It inhibits the generation of reactive oxygen species (ROS) by neutrophils, thereby reducing oxidative stress and the associated tissue damage. In rosacea specifically, azelaic acid reduces the activity of kallikrein-5 (KLK5), the enzyme responsible for processing cathelicidin into its pro-inflammatory form LL-37. By suppressing this pathway, azelaic acid directly addresses one of the key inflammatory mechanisms driving rosacea flares. Additionally, it has been shown to downregulate the expression of various pro-inflammatory cytokines, including interleukin-1β (IL-1β) and tumor necrosis factor-α (TNF-α).

The antikeratinizing (comedolytic) effect of azelaic acid involves the normalization of epidermal differentiation. In acne-prone skin, the cells lining the hair follicle shed abnormally and clump together, leading to the formation of microcomedones – the precursor lesions of all visible acne. Azelaic acid reduces this hyperkeratosis by modulating the expression of filaggrin and other proteins involved in epidermal cornification, thereby helping to keep pores clear and prevent the formation of new acne lesions.

What Should You Know Before Using Finacea?

Contraindications

There is one absolute contraindication to the use of Finacea gel: known hypersensitivity (allergy) to azelaic acid or any of the other ingredients in the formulation. The inactive ingredients include benzoic acid (E210), carbomer, disodium edetate, lecithin, polysorbate 80, propylene glycol, purified water, sodium hydroxide, and medium-chain triglycerides. If you have experienced an allergic reaction to any of these substances in the past, you should not use Finacea.

Allergic reactions to azelaic acid itself are very rare. However, the formulation contains benzoic acid, which can cause local skin irritation in some individuals, and propylene glycol, which is a common ingredient in topical preparations and cosmetics that may occasionally cause contact sensitization. If you know you are sensitive to either of these excipients, inform your doctor before starting treatment.

Warnings and Precautions

Before and during treatment with Finacea gel, be aware of the following important precautions:

• External use only: Finacea gel is strictly for topical application to the skin. It should never be taken orally or applied to mucous membranes.
• Avoid contact with eyes, mouth, and mucous membranes: The gel should not come into contact with the eyes, inside the mouth, the nostrils, or other mucous membranes. If accidental contact occurs, rinse thoroughly with plenty of water. If eye irritation persists after rinsing, consult a doctor or pharmacist promptly.
• Hand washing: Always wash your hands thoroughly after applying Finacea gel to prevent inadvertent transfer to sensitive areas such as the eyes.
• Avoid irritating products (rosacea): When using Finacea gel for the treatment of rosacea, you should avoid skin cleansers, solutions, and toners that contain alcohol, as well as abrasive scrubs and chemical peeling products. These can exacerbate skin irritation and undermine the benefits of treatment.
• Asthma: In rare cases, worsening of asthma symptoms has been reported in patients with pre-existing asthma who were being treated with azelaic acid. Although the systemic absorption of azelaic acid from topical application is minimal, patients with asthma should be aware of this potential association and report any changes in respiratory symptoms to their doctor.
• Skin irritation: Local skin reactions such as burning, stinging, and tingling are common, especially during the first weeks of treatment. These reactions are usually mild to moderate and tend to diminish over time. If irritation is severe or persistent, you may reduce the amount of gel applied, decrease to once-daily application, or temporarily pause treatment until symptoms subside. Consult your doctor if the irritation does not improve.
• Hypopigmentation: Azelaic acid has an inhibitory effect on tyrosinase, the enzyme responsible for melanin production. While this property can be beneficial for treating post-inflammatory hyperpigmentation, patients with darker skin tones should be monitored for any unwanted lightening of the treated skin areas. In clinical studies, depigmentation has been rare and reversible upon discontinuation.

Pregnancy and Breastfeeding

There is limited clinical data on the use of azelaic acid during pregnancy in humans. Animal studies have not shown direct harmful effects on fertility, pregnancy, or fetal development at relevant doses, but the standard precautionary principle applies: if you are pregnant, your doctor should assess the benefits and risks before prescribing Finacea.

Systemic absorption of azelaic acid after topical application is very low (approximately 3.6% of the applied dose enters the systemic circulation), and azelaic acid is a naturally occurring substance already present in the human body as an intermediate in fatty acid metabolism. Nevertheless, it is recommended to consult a healthcare provider before using Finacea during pregnancy or while planning to become pregnant.

It is not known whether topically applied azelaic acid is excreted in human breast milk in clinically significant quantities. Given the minimal systemic absorption, the risk to a breastfed infant is likely low. However, as a precaution, breastfeeding infants should not come into direct contact with treated skin areas. Your doctor should decide whether you can use Finacea while breastfeeding.

Children and Adolescents

The safety and efficacy of Finacea gel for the treatment of acne have been studied in adolescents aged 12 to 18 years. No dose adjustment is necessary for this age group, and the side effect profile is similar to that observed in adults. Finacea gel is not recommended for children under 12 years of age for the treatment of acne, as sufficient data on efficacy and safety are not available for this population.

For the treatment of rosacea, Finacea gel is not recommended for patients under 18 years of age, as rosacea is uncommon in children and adolescents, and there is insufficient data on the use of azelaic acid for this indication in younger patients.

Driving and Operating Machinery

Finacea gel has no known effect on the ability to drive or operate machinery. It is applied topically to the face and does not cause systemic effects such as drowsiness or dizziness that might impair concentration or motor skills.

Important Information About Ingredients

Finacea gel contains benzoic acid (1 mg per gram of gel). Benzoic acid may cause local skin irritation, particularly in individuals with sensitive skin. It is used as a preservative in the formulation.

Finacea gel also contains propylene glycol (120 mg per gram of gel). Propylene glycol is a common excipient in topical formulations that acts as a humectant and solvent. It may cause skin irritation in some individuals and, in rare cases, can lead to contact dermatitis. If you have a known sensitivity to propylene glycol, discuss this with your doctor before starting treatment.

How Does Finacea Interact with Other Drugs?

Azelaic acid has minimal systemic absorption when applied topically as Finacea 15% gel. Approximately 3.6% of the applied dose reaches the systemic circulation, and the plasma concentrations achieved are very low relative to the endogenous levels of azelaic acid already present in the body. Because of this negligible systemic exposure, clinically significant pharmacokinetic drug interactions (i.e., interactions involving drug metabolism, distribution, or elimination) are not expected.

No formal drug interaction studies have been conducted specifically with Finacea gel. However, based on the pharmacological profile and low systemic availability of azelaic acid, the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have not identified any specific drug interactions of clinical concern.

The primary consideration with Finacea is the concurrent use of other topical products on the same area of skin. Using multiple topical treatments simultaneously may increase the risk of skin irritation, alter the absorption characteristics of one or both products, or affect their stability on the skin surface.

Topical Interactions to Consider

As a general rule, do not apply other topical medications or treatments to the same area of skin at the same time as Finacea without consulting your healthcare provider. If your doctor prescribes additional topical treatments, they may recommend applying them at different times of day (for example, Finacea in the morning and a retinoid in the evening) to minimize the risk of irritation.

Always inform your doctor or pharmacist about all medications you are currently using, including prescription drugs, over-the-counter products, and skincare treatments, to ensure a comprehensive assessment of potential interactions.

What Is the Correct Dosage of Finacea?

Always use Finacea gel exactly as your doctor has instructed. If you are uncertain about any aspect of your treatment, consult your doctor or pharmacist for clarification. Finacea gel is for external (topical) use only and should be applied exclusively to the affected areas of the face.

How to Apply Finacea

Follow these steps for correct application:

1. Cleanse the skin: Before applying Finacea gel, thoroughly cleanse the affected skin with water and a mild, gentle cleanser. Pat the skin dry with a clean towel.
2. Apply a thin layer: Squeeze approximately 2.5 cm (about 0.5 grams) of gel from the tube. This amount is sufficient to cover the entire face. Apply a thin, even layer of gel to the affected areas.
3. Massage gently: Use clean fingertips to gently massage the gel into the skin until it is absorbed. Do not rub vigorously.
4. Wash your hands: Always wash your hands thoroughly after applying the gel to prevent accidental contact with your eyes or other sensitive areas.
5. Do not cover: Do not apply airtight or waterproof bandages or dressings over the treated area.

Adults

Children and Adolescents (12–18 years)

Treatment Duration

The duration of treatment depends on the condition being treated and the individual clinical response:

• Acne: Finacea gel can be used for several months depending on the effectiveness of treatment. A noticeable improvement is typically seen after approximately 4 weeks of consistent use. If no improvement is observed within 1 month, or if the acne worsens, discontinue treatment and consult your doctor.
• Rosacea: Finacea gel can be used for several months depending on the effectiveness of treatment. A clear therapeutic effect is usually seen after 4 to 8 weeks of consistent use. If no improvement is observed within 2 months, or if rosacea symptoms worsen, discontinue treatment and consult your doctor.

For both conditions, regular and consistent use throughout the treatment period is essential for achieving optimal results. Intermittent or irregular use will reduce the effectiveness of the treatment.

Missed Dose

If you forget to apply Finacea gel at the scheduled time, do not apply a double amount to make up for the missed dose. Simply continue with your regular treatment schedule as prescribed by your doctor. Missing a single application will not significantly affect the overall outcome of treatment, but consistent use is important for best results.

Overdose

Topical overdose with Finacea gel is unlikely to cause systemic toxicity because of the minimal absorption of azelaic acid through the skin. If an excessive amount is applied to the skin, it may increase local irritation. In such cases, simply wash off the excess gel with water.

If Finacea gel is accidentally swallowed (for example, if a child ingests the product), it is unlikely to cause serious poisoning. However, as a precaution, contact your doctor, hospital, or poison control center for an assessment of risk and guidance.

What Are the Side Effects of Finacea?

Like all medicines, Finacea gel can cause side effects, although not everyone experiences them. The side effects are almost exclusively limited to the skin at the site of application. In most cases, they are mild to moderate in severity and tend to diminish as the skin adjusts to the treatment over the first few weeks. The side effect profile is similar for both acne and rosacea indications.

Side Effects for Acne Treatment

Side Effects for Rosacea Treatment

The rare side effects listed above (hypersensitivity, urticaria, worsening asthma) have been identified from post-marketing surveillance reports after the drug was approved and became widely used. They occur very infrequently but should be taken seriously.

Adolescents (12–18 years)

In clinical studies evaluating Finacea gel for acne treatment in adolescents aged 12 to 18 years, the overall frequency and type of side effects were similar to those observed in adult patients. No additional safety concerns have been identified in this age group.

If you experience any side effects, including any not listed above, tell your doctor or pharmacist. You can also report suspected side effects to your national pharmacovigilance authority (e.g., the EMA in Europe, the FDA MedWatch program in the United States, or the MHRA Yellow Card Scheme in the United Kingdom) to help monitor the ongoing benefit-risk profile of Finacea.

How Should You Store Finacea?

Finacea gel has no special storage conditions. It should be stored at normal room temperature and does not need to be refrigerated. Keep the tube tightly closed when not in use to prevent the gel from drying out.

• Keep out of reach of children: Store the tube in a safe place where children cannot see or access it.
• Check the expiry date: Do not use Finacea gel after the expiry date printed on the carton and tube. The expiry date refers to the last day of the indicated month.
• Proper disposal: Do not throw unused or expired medication into the drain or with household waste. Ask your pharmacist about how to properly dispose of medicines that are no longer needed. These measures help protect the environment.

Finacea gel is available in tube sizes of 5 g, 30 g, 50 g, and 2 × 50 g. Not all pack sizes may be available in every market. The gel is a white to yellowish opaque preparation.

What Does Finacea Contain?

Active Substance

The active substance is azelaic acid (nonanedioic acid). Each gram of Finacea gel contains 150 mg of azelaic acid, corresponding to a 15% w/w concentration. Azelaic acid is a naturally occurring nine-carbon dicarboxylic acid with the molecular formula C₉H₁₆O₄ and a molecular weight of 188.22 g/mol. It appears as a white crystalline powder and is slightly soluble in water.

Inactive Ingredients (Excipients)

• Benzoic acid (E210): Preservative (1 mg per gram); may cause local irritation
• Carbomer: Gelling agent that gives the formulation its viscosity and consistency
• Disodium edetate: Chelating agent that helps maintain product stability
• Lecithin: Emulsifier that helps distribute the active ingredient evenly
• Polysorbate 80: Non-ionic surfactant and solubilizer
• Propylene glycol: Humectant and solvent (120 mg per gram); enhances skin penetration
• Purified water: Vehicle base
• Sodium hydroxide: pH adjuster
• Medium-chain triglycerides: Emollient component that contributes to the smooth texture of the gel

Appearance

Finacea gel is a white to yellowish opaque gel. It has a smooth, non-greasy consistency that spreads easily on the skin and is absorbed relatively quickly without leaving a heavy residue.

Manufacturer

Finacea is manufactured by LEO Pharma Manufacturing Italy S.r.l., Via E. Schering 21, I-20054 Segrate, Milano, Italy. The marketing authorization holder is LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark.

Finacea is approved within the European Economic Area under the brand name Finacea in Denmark, France, Iceland, Italy, Norway, Spain, Sweden, and the United Kingdom. In Austria, Finland, Germany, Greece, Ireland, and Portugal, the same active ingredient is marketed under the brand name Skinoren (at 20% concentration in cream formulation).