AKLIEF Cream 0.005% Trifarotene

Aklief

Medication

Topical retinoid cream (acne treatment)

Approved by regulatory authorities (e.g. US FDA, European EMA / national agencies) for treatment of acne vulgaris.
Manufactured under current Good Manufacturing Practice (cGMP) standards. (As per Galderma regulatory submission)

Approved by regulatory authorities (e.g. US FDA, European EMA / national agencies) for treatment of acne vulgaris.
Manufactured under current Good Manufacturing Practice (cGMP) standards. (As per Galderma regulatory submission)

Topical retinoid cream (acne treatment)

Description

AKLIEF Cream is a topical retinoid formulation containing 0.005% (50 µg/g) of trifarotene, used for the treatment of acne vulgaris. It is designed for cutaneous use on the face and/or trunk (chest, shoulders, back), helping to accelerate skin cell turnover, unclog pores, clear comedones and inflammatory lesions, and prevent new acne formation. The cream is intended for once-daily evening application on clean, dry skin.

Bnefits

Effective reduction of both inflammatory and non-inflammatory acne lesions (comedones, papules, pustules) on face and trunk.
Helps normalise skin cell turnover and prevent pore blockage by exfoliating dead skin cells.
Reduces inflammation associated with acne, helping improve redness, swelling and irritation.
Once-daily application makes adherence simpler compared to multiple-dose regimens.
Suitable for large treatment areas (trunk as well as face), unlike many older retinoids.

Indications

Treatment of acne vulgaris on the face and/or trunk (upper, middle, lower back; shoulders; chest) in patients aged 12 years and older.

Composition

Active ingredient: trifarotene 0.005% w/w (50 µg/g) – a selective retinoic acid receptor-γ (RAR-γ) agonist.
Excipients / inactive ingredients: allantoin; copolymer of acrylamide and sodium acryloyldimethyltaurate dispersion in isohexadecane; cyclomethicone; ethanol (approximately 5% v/v); medium-chain triglycerides; phenoxyethanol; propylene glycol; purified water.

Formulation

Topical cream (oil-in-water emulsion containing trifarotene 0.005%)

Packaging

Typically supplied in pump-dispenser tubes (e.g., 30 g, 45 g or 75 g) for controlled daily dosing.

Usage

Apply a thin layer of Aklief Cream once daily in the evening to clean, dry skin on affected areas (face and/or trunk).
Use one pump for the face (forehead, cheeks, nose, chin); two pumps for upper trunk (shoulders, upper back, chest), and additional pump(s) if covering middle or lower back, as needed.
Avoid applying on cuts, abrasions, eczematous or sunburned skin.
Do not apply near eyes, lips, mouth, or mucous membranes.
Use a gentle, non-medicated cleanser; avoid other harsh or irritating topical agents (e.g., abrasive cleansers, peeling agents, strong alcohol-based products).
Use moisturizer as needed from start of therapy to reduce dryness or irritation.
Avoid excessive sun exposure, tanning beds, or UV lamps; use sunscreen and protective clothing when outdoors.

Contraindications

Known hypersensitivity to trifarotene or any component of the cream.
Skin that is sunburned, cut, abraded, inflamed (e.g., eczematous skin), or otherwise damaged.
Use during pregnancy or in women planning to become pregnant — topical retinoids generally contraindicated during pregnancy.
Use of other topical acne treatments with peeling, irritant or drying effects (unless under physician supervision), as concurrent use may increase irritation risk.

Adverse Effects

Common: application site irritation including redness, dryness, itching, sunburn-like reaction, scaling, stinging or burning.
Possible worsening of acne or skin purging during first weeks of use.
Potential skin discoloration or hyperpigmentation changes.
Photosensitivity: increased risk of sunburn on treated skin.
Rare: allergic reactions (rash, swelling, severe irritation) — discontinue if these occur.

Storage Conditions

Store at controlled room temperature (approximately 20–25 °C / 68–77 °F), away from heat and direct sunlight.
Keep the pump tube tightly closed when not in use and out of reach of children.