AKLIEF

What it is

Aklief is a cream containing trifarotene 50 micrograms per gram . Trifarotene is a chemically stable, terphenyl acid derivative with retinoid-like activity . It is a relatively potent RARγ agonist (retinoid acid receptor γ agonist), characterised by its high specificity to this receptor over RARα and RARβ . The product is for topical use only .

Approved indications

— Topical treatment of acne vulgaris of the face and/or trunk in patients from 12 years of age and older, when many comedones, papules and/or pustules are present .

Dosing overview

Apply a thin layer of Aklief cream to the affected areas of the face and/or trunk once a day, in the evening, on clean and dry skin . One pump actuation should be enough to cover the face (forehead, cheeks, nose, and chin), and two pump actuations should be enough to cover the upper trunk (reachable upper back, shoulders and chest); one additional pump actuation may be used for middle and lower back if acne is present . The physician should assess continued improvement after three months of treatment, and the duration of treatment should be determined by the doctor based on clinical response .

Key safety warnings

Erythema, scaling, dryness, and stinging/burning may be experienced with use of Aklief cream, and to mitigate this risk, patients should be instructed to use a moisturiser from the initiation of treatment and, if appropriate, reduce the frequency of application or suspend use temporarily . Local cutaneous reactions such as erythema, scaling, dryness, and stinging/burning are very common, with up to 39% of patients experiencing mild reactions, 29.7% moderate and 6.2% severe on the face; on the trunk, up to 32.9%, 18.9% and 5.2% of patients had mild, moderate and severe reactions respectively, with maximum severity typically occurring at Week 1 for the face and at Week 2 to 4 for the trunk, and decreasing with continued use . Excessive exposure to sunlight, including sunlamps or phototherapy should be avoided during treatment, as an increased risk of sunburn was reported in 1.7% of children compared to 0.7% of adults, and use of a broad-spectrum, water-resistant sunscreen with a Sun Protection Factor (SPF) of 30 or higher and protective clothing over treated areas is recommended when exposure cannot be avoided . Aklief should not come into contact with the eyes, eyelids, lips, or mucous membranes, and if the product enters the eye, it should be rinsed immediately with plenty of lukewarm water . The product should not be applied to cuts, abrasions, eczematous or sunburnt skin .

Contraindications

Aklief is contraindicated in pregnancy and in women planning a pregnancy . It is also contraindicated in patients with hypersensitivity to trifarotene or to any of the excipients .

Regulatory history

Aklief was first approved on 11 January 2021 . Two ARTG registrations were granted on 18 January 2021: ARTG 332220 for the bottle formulation and ARTG 340375 for the tube formulation, both containing trifarotene 50 microgram/g cream . This medicinal product is subject to additional monitoring to allow quick identification of new safety information .