Trifarotene cream is a topical retinoid used to treat acne vulgaris in patients aged 9 years and older.

Trifarotene is a retinoic acid receptor (RAR) agonist, with specific activity toward the RAR-gamma subtype. Activation of these receptors helps regulate genes involved in important processes such as cell differentiation and inflammation control. The exact way Trifarotene improves acne is not fully understood.

Apply a thin layer of Trifarotene cream once daily in the evening to clean, dry skin on the affected areas. Moisturizer may be used as needed from the start of treatment. Avoid contact with the eyes, lips, skin folds beside the nose, and mucous membranes. Trifarotene cream is for external (topical) use only and must not be used orally, in the eyes, or intravaginally.

Drug interactions: When applied to the skin, Trifarotene cream is not expected to change the blood levels of oral hormonal contraceptives containing ethinylestradiol and levonorgestrel.

The most common side effects (occurring in more than 1% of patients) with Trifarotene cream include irritation at the application site, itching at the application site, and sunburn.

Pregnancy Category C. Clinical trial data in pregnant women using Trifarotene cream have not shown an increased risk of major birth defects, miscarriage, or harmful effects on the mother or fetus. The benefits of breastfeeding should be weighed against the mother’s need for Trifarotene cream, as well as any possible risks to the breastfed infant from the medicine or the mother’s condition.

Skin irritation: Patients using trifarotene cream may experience redness (erythema), peeling, dryness, and a stinging or burning sensation. These effects are usually strongest during the first 4 weeks of treatment and typically lessen with continued use. Depending on severity, patients may be advised to use a moisturizer, reduce the frequency of application, or temporarily stop treatment. If severe irritation continues, treatment may need to be discontinued. Avoid applying trifarotene cream on cuts, abrasions, eczema-affected skin, or sunburned skin. Waxing hair removal should not be performed on areas treated with trifarotene cream.

Ultraviolet light and environmental exposure: Limit unprotected exposure to UV radiation, including sunlight and tanning lamps, during treatment. Patients with high sun exposure or increased sun sensitivity should take extra care. When sun exposure cannot be avoided, the use of sunscreen and protective clothing over treated areas is recommended.

Pediatric Use: The safety and effectiveness of Trifarotene cream have not been established in children under 9 years of age.

Geriatric Use: Clinical studies of Trifarotene cream did not include participants aged 65 years and older, so it is not known whether they respond differently compared to younger patients.

Therapeutic Class: Topical retinoids and related formulations.

Store below 25°C. Keep protected from light and out of the reach of children.