Selective RAR-γ retinoid Pregnancy: Available data from clinical trials in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are case reports of major birth defects in pregnant women exposed to other topical retinoids, but these do not establish an association. In animal studies, oral trifarotene at exposures more than 800 times the maximum recommended human dose caused fetal deaths and external, visceral and skeletal malformations.

Trifarotene

Brand names: Aklief

Trifarotene is a topical retinoid used for the treatment of acne vulgaris affecting the face and trunk.

Adult dose

Dose: Apply a thin layer of 0.005% cream to the affected areas — one pump actuation should be enough to cover the face (forehead, cheeks, nose and chin); 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 the middle and lower back if acne is present

Route: Topical (cutaneous), applied to clean and dry skin — for topical use only; not for oral, ophthalmic or intravaginal use

Frequency: Once daily, in the evening

From US labelling (AKLIEF Cream 0.005%, Galderma; no UK SPC in the fetched bundle) — verify against a UK SPC before use. Each gram of cream contains 50 micrograms of trifarotene. Use of a moisturiser is recommended as frequently as needed from the initiation of treatment. Avoid contact with the eyes, lips, paranasal creases and mucous membranes; avoid application to cuts, abrasions, or eczematous or sunburned skin; avoid waxing as a depilatory method on treated skin. Erythema, scaling, dryness and stinging/burning may occur — maximum severity typically within the first 4 weeks; depending on severity, use a moisturiser, reduce the frequency of application, or suspend or discontinue use. Minimise unprotected exposure to ultraviolet rays, including sunlight and sunlamps. Paediatric: safety and effectiveness have been established for topical treatment of acne vulgaris in patients aged 9 to 17 years (same topical application; no per-kg dose stated); not established under 9 years of age.

Dose independently re-sourced from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

None (US label section 4 states 'None')

Side effects

Application site irritation
Application site pruritus
Sunburn
Erythema, scaling and dryness of treated skin
Stinging/burning at the application site

Interactions

Topical application is not expected to affect the circulating concentrations of oral hormonal contraceptives containing ethinyl estradiol and levonorgestrel

Clinical monograph

How it works

It is a selective retinoic acid receptor (RAR) gamma agonist that normalises follicular keratinisation and has anti-inflammatory effects, helping to prevent comedone formation.

Prescribing in practice

Topical retinoids are contraindicated in pregnancy and should be avoided when trying to conceive; counsel women of childbearing potential about effective contraception.
Local skin irritation, dryness, erythema and photosensitivity are common, particularly early in treatment.
Apply a thin film to clean dry skin in the evening and avoid contact with eyes, lips and mucous membranes as described in the SPC.

Monitoring

Review tolerability and treatment response at follow-up, reducing application frequency if irritation is troublesome.

Counselling the patient

Use sunscreen and limit sun exposure, as your skin will be more sensitive to sunlight.
Some redness, peeling and dryness is expected at first; use a non-comedogenic moisturiser.
Do not use if you are pregnant or planning pregnancy.

Evidence & guidelines

Topical retinoids are established first-line agents for acne in NICE guidance, and trifarotene's efficacy is supported by randomised controlled trials in facial and truncal acne.

Reference: NICE NG198; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Pathways