Product Dossier
DIFFERIN
Product Dossier for DIFFERIN (adapalene, Galderma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Galderma
- Active ingredient: adapalene
- Therapeutic area: Dermatology
- Related brand: EPIDUO
- Related brand: NOVADUO
- Related brand: ADAPAX
- Same area: DERMATANE
- Same area: NEOTIGASON
What it is
Differin is a topical cream containing adapalene 1 mg/g in a smooth white cream. Adapalene is a chemically stable compound with retinoid-like pharmacological activity that is a potent modulator of cellular differentiation, keratinisation and inflammatory processes, all of which represent important features in the pathology of acne vulgaris. Adapalene binds to specific retinoic acid nuclear receptors but unlike tretinoin does not bind to the cytosolic receptor protein, and topical adapalene normalises the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.
Approved indications
— Topical treatment of comedo, papular and pustular acne (acne vulgaris) of the face, chest or back.
Dosing overview
A thin film of Differin should be applied to the affected areas once a day before bedtime and after washing, avoiding the eyes, lips and mucous membranes. The affected areas should be dry before application. Clinical improvement is expected to be evident in 4 to 8 weeks of treatment, with further improvement to be expected with continued use.
Key safety warnings
Differin Topical Cream should not come into contact with the eyes, lips, mouth and mucous membranes, angles of the nose or broken skin (cuts and abrasions), sunburn or eczematous skin, nor should it be used in patients with severe acne involving large areas of the body. Because of a potential for increased irritation, Differin Cream should not be used by patients with eczema, seborrhoeic dermatitis or severe acne involving large areas of the body. Small numbers of reactions consistent with phototoxicity were reported in clinical studies, and the safety of using adapalene during long or repeated exposures to sunlight or UV radiation has not been established in animals or humans. Exposure to sunlight or UV irradiation (including sunlamps) should be avoided during treatment with adapalene, and use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Differin Cream contains methyl hydroxybenzoate and propyl hydroxybenzoate that can cause allergic reactions (which can arise after the treatment is completed).
Contraindications
Differin is not to be used in patients who are hypersensitive to the active substance or any of the excipients.
Regulatory history
Differin adapalene 1 mg/g gel was first listed on the ARTG on 29 November 1995. The topical cream formulation received initial approval on 22 September 1998. Updated registrations for Differin Acne Treatment in both gel and cream formulations were listed in 2023.