Azelaic 20% Cream (30g)

Skinoren

Topical dermatology medication

Prescription-only acne treatment (azelaic acid 20% cream)

UK MHRA Licensed medicinal product (Skinoren 20% Cream, PL 00043/0236).
Manufactured under EU/UK Good Manufacturing Practice (GMP) for medicinal products.
Distributed by Teleta Pharma, an MHRA Accredited, WDA Certified and GDP Compliant pharmaceutical wholesaler.

UK MHRA Licensed medicinal product (Skinoren 20% Cream, PL 00043/0236).
Manufactured under EU/UK Good Manufacturing Practice (GMP) for medicinal products.
Distributed by Teleta Pharma, an MHRA Accredited, WDA Certified and GDP Compliant pharmaceutical wholesaler.

Prescription-only acne treatment (azelaic acid 20% cream)

Description

Azelaic 20% Cream (30g) is a prescription-only topical cream containing 20% w/w azelaic acid (marketed as Skinoren 20% Cream). It is used for the topical treatment of acne vulgaris, particularly mild to moderate acne affecting the face, chest or back. The cream has antibacterial, anti-inflammatory and comedolytic properties, helping to reduce Propionibacterium acnes, normalize keratinization, and decrease formation of comedones and inflammatory lesions.

Bnefits

Topical treatment for mild to moderate acne vulgaris
Reduces formation of comedones (blackheads and whiteheads)
Antibacterial action against acne-causing bacteria (Propionibacterium acnes / Cutibacterium acnes)
Anti-inflammatory effect, helping to reduce redness and swelling of acne lesions
Helps to prevent new acne lesions while treating existing ones
Well-established safety profile with low systemic absorption
Alcohol-free cream base suitable for long-term use when tolerated

Indications

Topical treatment of acne vulgaris in patients aged 12 years and older
Mild to moderate acne on the face, chest and/or back, including inflammatory lesions and comedones

Composition

Azelaic acid 20% w/w (200 mg azelaic acid per 1 g cream) – active ingredient
Benzoic acid (E210) – preservative, may cause local irritation
Cetearyl octanoate + isopropyl myristate (PCL Liquid)
Glycerol 85%
Propylene glycol – humectant, may cause local irritation
Purified water
Stearoyl macrogolglycerides
Glycerol monostearate 40–55
Cetostearyl alcohol – emulsifying agent, may cause local skin reactions (e.g. contact dermatitis)

Formulation

Topical cream for cutaneous use
White, opaque cream
Strength: 20% w/w azelaic acid (200 mg/g)
Pack size: 30 g aluminium tube

Packaging

Aluminium tube with internal epoxide coating and polyethylene screw cap
30 g tube (other pack sizes such as 20 g and 50 g exist for the same brand, but Teleta supplies the 30 g pack)
Outer carton with patient information leaflet

Usage

For cutaneous use only.
Apply Skinoren (Azelaic 20% Cream) to the affected areas of skin twice daily (morning and evening).
As a guide, approximately 2.5 cm of cream (about 0.5 g) is sufficient for the entire facial area.
If other areas (e.g. chest and back) also require treatment, adjust the amount of cream accordingly.
Before application, thoroughly cleanse the skin with plain water and gently dry; a mild skin-cleansing agent may be used.
Gently rub the cream into the affected areas.
In patients with sensitive skin, use once daily (in the evening) during the first week of treatment, then increase to twice daily as tolerated.
In the event of intolerable skin irritation, reduce the amount of cream applied or reduce the frequency to once daily until irritation subsides; if needed, treatment may be temporarily interrupted for a few days.
Avoid contact with eyes, mouth and other mucous membranes; if accidental contact occurs, rinse with plenty of water.
Wash hands after each application.

Contraindications

Known hypersensitivity to azelaic acid.
Hypersensitivity to any of the excipients (including benzoic acid, propylene glycol or cetostearyl alcohol).

Adverse Effects

Very common: application site burning, application site pruritus (itching), application site erythema (redness).
Common: application site exfoliation (peeling), pain, dryness, discolouration or irritation.
Uncommon: application site paraesthesia (tingling), dermatitis, discomfort, oedema (swelling).
Rare or frequency not known: application site vesicles or eczema, warmth, ulcer; urticaria; rash; cheilitis.
Hypersensitivity reactions including angioedema, contact dermatitis, eye swelling, facial swelling.
Worsening of asthma has been reported rarely in patients treated with azelaic acid.
Local irritation usually decreases as treatment continues.

Storage Conditions

Do not store above 30°C.
Keep the tube tightly closed when not in use.
Shelf life of unopened pack: typically 3 years (refer to pack expiry date).
In-use shelf life after first opening: up to 6 months, provided storage conditions are followed.
Keep out of the sight and reach of children.

Duration

Duration of use varies between patients and depends on acne severity. A distinct improvement is generally seen after about 4 weeks. For optimal results, continuous use over several months is recommended. Clinical experience supports continuous use for up to one year under medical supervision.