trifarotene
Regulatory sources consulted
Approved indications
- Cutaneous treatment of acne vulgaris on the face, chest, or back with numerous comedones, papules, and pustules in patients older than 12 years.
Contraindications
Absolute
- Hypersensitivity to trifarotene or excipients; pregnancy or plans to become pregnant.
Clinical warnings
- Major warning · It may cause erythema, scaling, dryness, itching, or burning. Use a moisturizer; reduce frequency, pause, or discontinue if severe reactions persist. — CIMA/AEMPS, ficha técnica 85017
- Do not apply to cuts, abrasions, eczema, or sunburn; avoid waxing, the eyes, lips, mucous membranes, and excessive sunlight or UV exposure. Use SPF 30 or higher and protective clothing. — CIMA/AEMPS, ficha técnica 85017
Drug interactions
- ModeratePeeling, irritating, or drying cosmetics or acne medicines
Mechanism: They may cause additive irritation.
Recommendation: Use cautiously and adjust according to local tolerability.
CIMA/AEMPS, ficha técnica 85017https://cima.aemps.es/cima/dochtml/ft/85017/FT_85017.html
Adverse events
Common (≥1%)
Application-site irritation · Application-site itching · Sunburn
Pregnancy and lactation
Contraindicated during pregnancy and in women planning pregnancy; stop if pregnancy occurs. During breastfeeding, decide whether to stop breastfeeding or treatment according to benefits, and do not apply to the chest or breast.
Recent literature (PubMed)
Acne vulgaris commonly affects adults, adolescents, and preadolescents aged 9 years or older. The objective of this study was to provide evidence-based recommendations for the management of acne. A work group conducted a systematic review and applied the Grading of Recommendations, Assessment, Development, and Evaluation approach for assessing the certainty of evidence and formulating and grading recommendations. This guideline presents 18 evidence-based recommendations and 5 good practice statements. Strong recommendations are made for benzoyl peroxide, topical retinoids, topical antibiotics, and oral doxycycline. Oral isotretinoin is strongly recommended for acne that is severe, causing psychosocial burden or scarring, or failing standard oral or topical therapy. Conditional recommendations are made for topical clascoterone, salicylic acid, and azelaic acid, as well as for oral minocycline, sarecycline, combined oral contraceptive pills, and spironolactone. Combining topical therapies with multiple mechanisms of action, limiting systemic antibiotic use, combining systemic antibiotics with topical therapies, and adding intralesional corticosteroid injections for larger acne lesions are recommended as good practice statements. Analysis is based on the best available evidence at the time of the systematic review. These guidelines provide evidence-based recommendations for the management of acne vulgaris.
Topical retinoids have an essential role in treatment of acne. Trifarotene, a topical retinoid selective for retinoic acid receptor (RAR) γ, is the most recent retinoid approved for treatment of acne. RAR-γ is the most common isoform of RARs in skin, and the strong selectivity of trifarotene for RAR-γ translates to efficacy in low concentration. Trifarotene, like other topical retinoids, acts by increasing keratinocyte differentiation and decreasing proliferation, which reduces hyperkeratinization. Retinoids have also been shown to inhibit inflammatory pathways via effects on leukocyte migration, toll-like receptors, and Activator Protein (AP)-1. Large-scale randomized, controlled clinical trials have demonstrated trifarotene to be safe, well tolerated, and efficacious in reducing both comedones and papules/pustules of acne. However, unlike all other retinoids, trifarotene is the first topical retinoid with rigorous clinical data on safety and efficacy in truncal acne. Data supporting use of trifarotene to manage acne are reviewed in this publication. Trifarotene has not been studied during breastfeeding. Because it is poorly absorbed after topical application, it is a low risk to the nursing infant. Do not apply trifarotene cream directly to the nipple and areola and ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated.
Although many treatments are available for acne, these can be limited by lack of effectiveness, patient tolerance and adherence, and accessibility. This review provides a comprehensive summary of the latest developments in acne management, exploring a range of topical, systemic, and procedural treatments. The mechanisms of action, pivotal trial data, and potential role in clinical practice are reviewed for emerging therapies such as 1726 nm laser, sarecycline, clascoterone, trifarotene, minocycline foam, and fixed-dose combination topicals. The clinical pipeline is also summarized. In addition, opportunities to improve the patient experience with spironolactone and isotretinoin are discussed.
This evidence- and consensus-based guideline for the treatment of acne was developed in accordance with the EuroGuiDerm Guideline and Consensus Statement Development Manual. This guideline is an update of the 2016 version. This is a short summary of the full version of the EuroGuiDerm Evidence-based Guideline for the Treatment of Acne. For the complete guideline text, detailed methods report, and comprehensive evidence report, please refer to the online full version. In this targeted update, the guideline group prioritized three key clinical questions considered most relevant for current practice: (a) For which types of acne and patient groups should isotretinoin be recommended versus systemic antibiotics, and with what strength of recommendation? (b) What is the appropriate duration for systemic antibiotic therapy? For which types of acne and patient groups should hormonal treatments and spironolactone be recommended, and with what strength of recommendation? For which types of acne and patient groups should new topical treatments, including trifarotene and clascoterone, be recommended and with what strength of recommendation? Additionally, the updated guideline provides revised recommendations regarding: safety of benzoyl peroxide (BPO), selection of systemic antibiotic therapy, treatment considerations during pregnancy, isotretinoin dosing strategies, and the use of hormonal antiandrogenic contraceptives or other combined hormonal contraceptives, as well as spironolactone. All other aspects remain unchanged from the 2016 guideline.