Skinoclear (Cream, Gel) Instructions for Use

ATC Code

D10AX03 (Azelaic acid)

Active Substance

Azelaic acid (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug for the treatment of acne

Pharmacotherapeutic Group

Drugs for the treatment of acne; drugs for the treatment of acne for topical use; other drugs for the treatment of acne for topical use

Pharmacological Action

A drug for the treatment of acne. It has antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis.

In addition, it reduces the content of free fatty acids in skin lipids and normalizes impaired keratinization processes in the sebaceous gland follicles.

Pharmacokinetics

After application to the skin, Azelaic acid penetrates the epidermis and dermis.

Part of the absorbed azelaic acid is excreted by the kidneys unchanged, and part in the form of dicarboxylic acids (C5, C7), formed from azelaic acid as a result of beta-oxidation.

Indications

Apply topically for the treatment of the following dermatological conditions.

• Acne vulgaris
• Seborrheic dermatitis
• Rosacea, including presentations with papules and pustules
• Pathological hyperpigmentation, such as melasma

Use only on the affected skin areas as directed by a physician.

ICD codes

Dosage Regimen

Apply a thin layer of the cream or gel to the affected skin areas twice daily, in the morning and evening.

Thoroughly cleanse and dry the skin prior to each application. The dose and duration of treatment are set individually by the physician based on the condition being treated and its severity.

Continue use for the full prescribed duration to achieve optimal therapeutic effect.

Adverse Reactions

Primarily local skin reactions, which are usually mild and transient, occurring mainly at the beginning of therapy.

These include skin irritation, erythema, a burning sensation, itching, and peeling. These reactions typically disappear on their own during continued treatment.

Discontinue use and consult a physician if severe irritation or signs of a contact allergic reaction develop.

Contraindications

Do not use under the following conditions.

• Known hypersensitivity to azelaic acid or any of the excipients in the formulation.
• Treatment of acne in children under 12 years of age.
• Treatment of rosacea in children and adolescents under 18 years of age.

Drug Interactions

No specific drug interactions are known for topical azelaic acid formulations.

Exercise caution when using concurrently with other topical medicinal products, especially those with a strong drying or irritant effect, such as topical tretinoin, as this may increase skin irritation.

Avoid using abrasive or exfoliating cleansers during therapy.

Overdose

Acute overdose from topical application is unlikely due to minimal systemic absorption.

Excessive application may lead to increased local adverse reactions, such as severe redness, pruritus, or burning. In case of accidental ingestion, seek medical attention immediately.

Treatment is symptomatic and supportive; there is no specific antidote.

Use in Pregnancy and Lactation

Use during pregnancy is possible if indicated.

Given the low systemic bioavailability and low toxicity of azelaic acid, use during lactation (breastfeeding) is possible.

In experimental studies on laboratory animals, no negative effect of azelaic acid on reproductive function was revealed, and no embryotoxic or teratogenic effects were established.

Pediatric Use

Contraindicated in children under 12 years of age for acne, in children under 18 years of age for rosacea.

Special Precautions

Avoid contact with mucous membranes and eyes.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.