Lumiface0.005%

Lumiface is a topical retinoid indicated for the treatment of acne vulgaris in patients 9 years of age and older.

• Established/FDA-approved use: Topical treatment of acne vulgaris of the face and/or trunk (back, chest, and shoulders) — Lumiface is one of the few topical retinoids specifically studied and approved for truncal acne.

Use of Lumiface for dermatologic conditions other than acne vulgaris has not been established and is not recommended.

Each gram of Trifarotene cream contains Trifarotene 0.005% (50 mcg/g) in a cream base intended for external topical application.

Lumiface is a fourth-generation synthetic topical retinoid that selectively targets the retinoic acid receptor gamma (RAR-γ), the predominant retinoic acid receptor subtype found in human skin. It is formulated as a once-daily topical cream for the treatment of acne vulgaris affecting the face and trunk.

Lumiface belongs to the topical retinoid class of medications, specifically a fourth-generation retinoid selective for the RAR-gamma receptor. It is classified as a topical anti-acne agent.

Mechanism of Action

Trifarotene is a retinoic acid receptor (RAR) agonist with selective, high-affinity activity at the RAR-gamma subtype, the most abundant RAR in the epidermis. By binding RAR-gamma (which heterodimerizes with retinoid X receptors), Trifarotene modulates gene transcription involved in keratinocyte differentiation and proliferation, and exerts anti-inflammatory effects on pathways implicated in acne pathogenesis.

Pharmacokinetics

• Absorption: Low systemic absorption with topical use; plasma concentrations reach steady state within about 2 weeks of once-daily application, with peak levels typically in the low picogram/mL range.
• Metabolism: Primarily hepatic, via CYP2C9, CYP3A4, and CYP2C8.
• Elimination half-life: Approximately 2-9 hours.
• Excretion: Predominantly fecal.

Lumiface is for external, topical use only.

• Wash and gently dry the skin before application.
• Apply only once daily, in the evening.
• Use the recommended amount per pump; do not exceed the recommended amount or frequency.
• Avoid contact with the eyes, lips, corners of the nose, and mucous membranes; rinse thoroughly with water if accidental contact occurs.
• Wash hands after applying Lumiface.
• Do not apply to cut, abraded, eczematous, or sunburned skin.

Lumiface is applied topically with minimal systemic absorption, so clinically significant systemic drug interactions are not expected. Lumiface has not been shown to alter circulating levels of oral hormonal contraceptives.

• Other topical retinoids, strong exfoliants, or high-concentration benzoyl peroxide: Concomitant use of other potentially irritating topical products with Lumiface may increase skin irritation and is not recommended unless specifically directed by a physician.
• Photosensitizing agents: Concurrent use of other drugs that increase photosensitivity may add to the sun-sensitivity risk associated with Lumiface (see Precautions and Warnings).

The most commonly reported adverse reactions with Lumiface are local skin reactions, generally most pronounced during the first 4 weeks of treatment and decreasing thereafter:

• Application-site irritation (erythema/redness)
• Scaling and dryness
• Stinging or burning sensation
• Pruritus (itching) at the application site
• Sunburn or increased sun sensitivity

Severe or persistent irritation, blistering, or signs of an allergic reaction (rash, swelling, difficulty breathing) with Lumiface should prompt discontinuation and medical evaluation.

Pregnancy

Lumiface should not be used during pregnancy. Although systemic absorption from topical use is low, retinoids as a class carry a risk of fetal harm, and human data on Lumiface use in pregnant women are limited. Use only if clearly needed and after consulting a physician; women of reproductive potential should use effective contraception while using Lumiface.

Lactation

It is not known whether topical Lumiface passes into breast milk in clinically relevant amounts. If used while breastfeeding, apply Lumiface to the smallest area of skin needed and for the shortest duration, and avoid application to the nipple/areola area. Consult a physician before using Lumiface while breastfeeding.

Skin Irritation

Erythema, scaling, dryness, and stinging/burning are common with Lumiface, especially in the first few weeks of use. If irritation is significant, reduce application frequency, use a moisturizer, or temporarily suspend treatment, then resume as tolerated.

Photosensitivity

Lumiface may increase skin sensitivity to sunlight. Minimize sun exposure and use of sunlamps/tanning beds during treatment; use sunscreen and protective clothing over treated areas when sun exposure cannot be avoided.

Avoid Irritated or Damaged Skin

Do not apply Lumiface to eczematous, sunburned, windburned, or broken/abraded skin.

Concomitant Topical Products

Avoid concurrent use of other potentially irritating topical products (other retinoids, strong exfoliants, high-concentration benzoyl peroxide, astringents) with Lumiface unless directed by a physician (see Interactions).

Application Area and Frequency

Do not exceed the labeled application area or frequency; applying more Lumiface than directed increases irritation without added benefit.

Not for Oral, Ophthalmic, or Mucosal Use

Lumiface is for external skin use only; avoid contact with the eyes, lips, and mucous membranes.

Lumiface is intended for topical use only. Excessive application does not speed improvement and instead increases the risk of local skin irritation, redness, and peeling. Accidental ingestion of Lumiface cream is unlikely to cause serious systemic toxicity given its minimal systemic absorption; however, if a large amount is swallowed or a severe reaction occurs, seek immediate medical attention or contact a poison control center/emergency services. Do not attempt home treatment of a suspected overdose.

Store Lumiface cream at room temperature, between 20°C and 25°C (68°F-77°F); brief exposure to 15°C-30°C during travel is permitted. Keep the tube/pump tightly closed and away from excessive heat and direct light. Keep out of reach of children.

Pediatric

Safety and efficacy of Lumiface are established in patients 9 to 17 years of age for acne vulgaris. Safety and efficacy in children under 9 years have not been established.

Geriatric

Clinical studies of Lumiface did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adults.

Renal/Hepatic Impairment

No specific dose-adjustment data are available for Lumiface in renal or hepatic impairment; given minimal systemic absorption with topical use, clinically significant effects are not expected, but physician guidance is advised.

Improvement with Lumiface is typically evaluated after approximately 12 weeks of consistent, once-daily use; benefit may continue to accrue with longer-term treatment (studied for up to 52 weeks). Treatment duration should be individualized by the prescribing physician based on response and tolerability. Do not stop or restart Lumiface without medical advice.

Topical retinoid; fourth-generation retinoic acid receptor (RAR) agonist selective for RAR-gamma.

Trifarotene selectively binds and activates the retinoic acid receptor gamma (RAR-γ), the dominant RAR subtype in skin, modulating expression of genes that regulate keratinocyte differentiation, proliferation, and inflammatory pathways involved in the formation of acne comedones and lesions.

Lumiface is approved for use in patients 9 years of age and older for acne vulgaris of the face and/or trunk. Safety and efficacy in children younger than 9 years have not been established, and Lumiface should not be used in this age group.