adapalene + benzoyl peroxide: clinical use

Prescribing considerations

• Licensed for acne vulgaris with comedones, papules and pustules in adults and adolescents aged 12 years and over.
• Efficacy and safety have not been established for severe nodular or deep nodulocystic acne.
• Safety and efficacy are not established in children under 12 or adults aged 65 years and over; renal and hepatic impairment have not been studied.

Contraindications and cautions

• Pregnancy
• Planning a pregnancy
• Hypersensitivity to adapalene, benzoyl peroxide or an excipient

Monitoring

• Review clinical response and local tolerability.
• Check for persistent erythema, scaling, burning, eczema, allergic contact dermatitis or application-site burns.
• No routine laboratory monitoring is specified in the selected SmPC.

Clinical pharmacology

Adapalene binds retinoic-acid nuclear receptors, normalising follicular epithelial differentiation and reducing inflammatory signalling. Benzoyl peroxide is bactericidal against Cutibacterium acnes through oxidative activity and also has keratolytic effects. Adapalene absorption is low; benzoyl peroxide is converted in the skin to benzoic acid and rapidly eliminated.

Formulation and product differences

• The selected product is a white to very pale-yellow gel containing adapalene 0.3% and benzoyl peroxide 2.5%.
• A lower-adapalene-concentration fixed-combination gel is also available.
• Skin-related adverse events occurred more frequently with the selected higher-adapalene formulation than with the lower-concentration formulation in the pivotal study.
• The selected gel contains propylene glycol, which may irritate skin, and can contain benzoic acid formed from benzoyl peroxide degradation.

Gel

Route: Cutaneous

Strengths: 0.1% + 2.5%, 0.3% + 2.5%