Azelaic 20% Cream (30g)

Azelaic 20% Cream (30g)

Skinoren

Topical dermatology medication
  • 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.

Onset

A noticeable improvement in acne is typically observed after approximately 4 weeks of regular twice-daily application.

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