Aklief (trifarotene) / Galderma - LARVOL DELTA

Patient Insights on Acne Hyperpigmentation, Trifarotene, and Skincare: 6-Month, LEAP Phase 4 Qualitative Exit Interview Findings. (PubMed, Patient) - P4 | "All trifarotene-treated patients reported improvements in AIH and that their treatment expectations were met. Findings support that trifarotene plus a skincare regimen provides greater benefit in the improvement of AIH than its VC. However, VC plus a skincare regimen also appeared to improve patients' perceptions of their AIH."

Interview • Journal • P4 data • Acne Vulgaris

AKLIEF: A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris (clinicaltrials.gov) - P3 | N=561 | Recruiting | Sponsor: Galderma R&D | Not yet recruiting ➔ Recruiting

Enrollment open • Acne Vulgaris • Dermatology

Treatment of flat warts with trifarotene. (PubMed, Dermatol Reports) - "The therapy allowed for the rapid resolution of warts, avoiding invasive and potentially scarring treatments, particularly crucial for pediatric patients and young adults. These findings suggest that trifarotene may provide a cosmetically favorable and effective alternative for managing flat warts, warranting further investigation."

Journal • Acne Vulgaris • Dermatology • Pediatrics

The Next Generation of Skin Care: Transforming Retinoid Therapeutics. (PubMed, Cells) - "Advances in medicinal chemistry have yielded synthetic retinoids with enhanced receptor selectivity, particularly for RAR-γ agonists such as trifarotene, as well as inhibitors of cytochrome P450-mediated retinoic acid metabolism, which sustain endogenous activity and mitigate resistance (DX314 and other RAMBAs). In parallel, the development of nanocarriers, stimuli-responsive gels, and other targeted delivery systems has improved drug stability, bioavailability, and tolerability. Together, these innovations underscore the evolving role of retinoid-based interventions in precision dermatology, providing opportunities to optimize treatment outcomes for acne, psoriasis, photoaging, and other dermatological disorders while addressing the shortcomings of earlier generations."

Journal • Review • Acne Vulgaris • Dermatology • Immune Modulation • Immunology • Psoriasis

Segmental Lichen Planus Pigmentosus Successfully Treated With Picosecond Neodymium-Doped: Yttrium-Aluminium-Garnet Laser and Trifarotene in a Korean Patient. (PubMed, Australas J Dermatol) - "We report a case of a 22-year-old Korean male with LPP who showed considerable improvement following combination therapy with trifarotene and a picosecond neodymium-doped yttrium-aluminium-garnet (Nd:YAG) laser. Considering the inherently variable clinical course of LPP and the challenges associated with its treatment, the combination of topical retinoids and picosecond Nd:YAG lasers appears to be a promising therapeutic approach."

Journal • Dermatology • Dermatopathology • Lichen Planus

Hub 2.07 A holistic approach to acne and acne sequelae: Combining retinoids, CTMP™ and cosmetic corrective procedures (EADV 2025) - "They will also explore the CTMP™ regimen and the integration of cosmetic corrective procedures as part of a holistic approach to improve treatment outcomes and skin quality in patients with acne and acne sequelae. Finally, the panel will present real-world patient case studies illustrating the use of trifarotene alongside CTMP™ or cosmetic corrective procedures."

Acne Vulgaris

AKLIEF: A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris (clinicaltrials.gov) - P3 | N=561 | Not yet recruiting | Sponsor: Galderma R&D

New P3 trial • Acne Vulgaris • Dermatology

Preclinical assessment of a CYP26B1 inhibitor for treating acne and keratinization disorders. (ESDR 2025) - "Local tolerance was assessed against marketed retinoids Trifarotene and Tazarotene in Göttingen minipigs over three weeks, and comedolytic activity was evaluated in rhino mice. Pregnant rats treated with the dual CYP26A1/B1 inhibitor showed complete early resorptions and no live fetuses. These results suggest CYP26B1 inhibitors are promising for treating keratinization disorders and acne with fewer retinoid-induced side effects."

Preclinical • Acne Vulgaris • Atopic Dermatitis • Immunology • Vitiligo • CYP26A1

Skin-Colored Papules on the Neck of a Postmenopausal Woman: A Diagnostic Challenge. (PubMed, Dermatopathology (Basel)) - "Verhoeff Van Gieson stain highlighted a band-like zone of attenuated elastic fibers in the papillary dermis, while Von Kossa stain was negative for calcified fibers. PAS staining was negative for fungal organisms and Alcian blue showed no increase in dermal mucin."

Journal • Dermatopathology

Novel combination of oral dapsone and topical trifarotene in severe recalcitrant isotretinoin-resistant nodulocystic acne. (PubMed, Indian J Dermatol Venereol Leprol) - No abstract available

Journal • Acne Vulgaris

A Retrospective Analysis of Adherence to Acne Treatment Guidelines (AAD 2025) - "Topical treatments (adapalene, benzoyl peroxide, tazarotene, tretinoin, trifarotene) tried within 12 months prior to antibiotics were included. This study provides an automated approach to assess adherence to acne treatment guidelines. Next steps involve educating providers on these guidelines and assessing changes in adherence."

Adherence • Retrospective data • Acne Vulgaris • Dermatology • Dermatopathology • Hidradenitis Suppurativa • Immunology • Infectious Disease • Malaria • Pneumonia • Respiratory Diseases • Rosacea

Cleanse, Treat, Moisturize, Protect (CTMP®) regimen: Enhancing skin quality and treatment outcomes in acne and sensitive skin (AAD 2025) - "Retinoids, such as adapalene, tretinoin, tazarotene, and trifarotene, are considered fundamental topical acne treatments as they target multiple disease aspects (5), and are frequently studied with regimens of cleansers, moisturizers, and protection (6-11). The review also found that combined drug treatments (e.g., topical trifarotene or other retinoids) and corrective procedures (e.g., fillers) may provide optimal treatment outcomes and satisfaction for some patients (21). Overall, the narrative review found that CTMP® may improve adherence, treatment outcomes, patient satisfaction, and overall skin quality in patients with acne and/or sensitive skin."

Clinical • Acne Vulgaris

Retinoids as Alternative Antifungal Agents Against Candida albicans: In Vitro and In Silico Evidence. (PubMed, Microorganisms) - "Here, we further investigated the possible anti-Candida potential of trifarotene and tazarotene, which are the other two molecules belonging to the retinoid family, compared to ATRA. In silico studies suggest that all three retinoids may exert antifungal activity through their molecular interactions with the heat shock protein (Hsp) 90 and 14α-demethylase of C. albicans. Moreover, interactions between retinoids and ergosterol have been observed, suggesting that those compounds have great potential against C. albicans infections."

Journal • Preclinical • Candidiasis • Dermatology • Infectious Disease

Recommendations to Improve Outcomes in Acne and Acne Sequelae: A Focus on Trifarotene and Other Retinoids. (PubMed, Dermatol Ther (Heidelb)) - "Adapalene, tretinoin and tazarotene have demonstrated efficacy in reducing acne and acne sequelae in several studies. Finally, management of acne and acne sequelae should include maintenance therapy with topical retinoids. This article supports the American Academy of Dermatology's call for acne sequelae treatment guidance and emphasizes the need for continued research to optimize patient care."

Journal • Acne Vulgaris • Dermatology

A Real-World Approach to Trifarotene Treatment in Patients with Acne and Acne Sequelae Based on the Experience of the Italian Acne Board. (PubMed, Dermatol Ther (Heidelb)) - "Owing to its long-term efficacy and tolerability, trifarotene is also a good option as a maintenance treatment. As with other topical retinoids, patients undergoing trifarotene therapy should be given advice on how to minimise local irritation when starting treatment."

Journal • Real-world evidence • Acne Vulgaris • Dermatology

A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris (clinicaltrials.gov) - P1 | N=1000 | Completed | Sponsor: Taro Pharmaceuticals USA

New P1 trial • Acne Vulgaris • Dermatology

A Multimodal Approach to Acne-Induced Post-Inflammatory Hyperpigmentation: Trifarotene as a Long-Term Intervention. (PubMed, Skin Therapy Lett) - "Trifarotene, a novel fourth generation retinoid selective for retinoid acid receptor gamma, is approved for the management of moderate-to-severe facial and truncal acne, with recent data supporting its efficacy in acne-induced hyperpigmentation. The purpose of this paper is to review treatment modalities for post-inflammatory hyperpigmentation and present trifarotene as a novel, evidence-based topical option."

Journal • Review • Acne Vulgaris • Dermatology

Innovations in Acne. (PubMed, Dermatol Clin) - "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."

Journal • Review • Acne Vulgaris • Dermatology

One Acne™: a holistic management approach to improve overall skin quality and treatment outcomes in acne with or without sensitive skin. (PubMed, Int J Dermatol) - "Tretinoin, trifarotene, adapalene, and tazarotene have all been assessed in clinical studies for managing acne-associated scarring, with varying success, with the latter three reported to improve skin quality. This narrative review highlights that comprehensive skincare regimens should be used throughout acne patients' journeys to reduce treatment-related irritation, improve treatment outcomes, adherence, and satisfaction, and enhance overall skin quality. Patients with sensitive skin should choose tailored skincare products to maintain skin barrier integrity and restore skin function."

Journal • Review • Acne Vulgaris • Dermatology

An update on the pharmacological management of acne vulgaris: the state of the art. (PubMed, Expert Opin Pharmacother) - "Topical therapies such as topical retinoids, benzoyl peroxide, azelaic acid, salicylic acid, topical antibiotics and clascoterone, as well as systemic treatments such as oral antibiotics and isotretinoin are discussed in detail. Combined oral contraceptives and spironolactone will not be discussed in this article. There is a need for a blockbuster acne drug that simultaneously targets the 4 main pathogenic factors involved in the appearance of acne lesions while presenting with minimal side effects. Until such a drug exists, combination therapy will remain the standard of treatment for most acne patients."

Journal • Review • Acne Vulgaris • Dermatology • Inflammation

Evidence for trifarotene in the management of acne and acne sequelae (EADV 2024) - "Sponsored by Galderma."

Acne Vulgaris

Hub 1.14 OneAcne: A holistic management approach to improve treatment outcomes in acne, acne sequelae and skin quality (EADV 2024) - "Furthermore, they will delve into the current understanding of the pathogenesis of acne, atrophic acne scarring and acne-induced hyperpigmentation, while also sharing data from the Phase 4 START and LEAP post hoc analyses on topical treatments with trifarotene for these conditions. Join the conversation! We encourage you to share your thoughts and ask questions in an interactive Q&A at the end of the session."

Clinical • Acne Vulgaris

Beyond Active Ingredients: The Impact of Control Arms in Dermatology (EADV 2024) - " Acne: Two identical, large-scale, 12-week, double-blinded, randomised, multicentre, and vehicle-controlled phase 3 studies (n = 1,524 and n = 1,293) demonstrated that once-daily application of trifarotene 50 μ g/g cream significantly improved both facial and truncal acne, with success rates of up to 42.3% and 42.6%, and reduced mean inflammatory lesions by up to 66.2% and 65.4%, respectively (p < 0.001 for all factors)...Rosacea: Two identical, large-scale, 12-week, double-blinded, randomised, multicentre, and vehicle-controlled phase 3 studies (n = 683 and n = 688) showed effectiveness of once-daily application of ivermectin 1% cream in reducing rosacea symptoms, with success rates reaching 38.4% and median inflammatory lesion reduction reaching 76.0% (p < 0.001 for both)...Melasma: A 40-week, randomised, and vehicle-controlled trial (n = 30) showed that twice-daily application of isotretinoin 0.05% gel insignificantly reduced melasma severity and melanin..."

Acne Vulgaris • Actinic Keratosis • Dermatology • Dermatopathology • Rosacea

Phase 4 analyses: Trifarotene reduces atrophic acne scars across all skin types with greater effect in subjects with higher baseline acne and acne scarring severity (EADV 2024) - "Trifarotene was efficacious in reducing acne scars across subgroups examined with a much higher treatment effect in subjects with more severe acne and/or acne scarring."

Clinical • P4 data • Acne Vulgaris • Dermatology

Unlocking the patient perspective: Exploring acne-induced hyperpigmentation in the Phase 4 LEAP study (EADV 2024) - "Although the LEAP study clinical endpoints did not reach statistical significance at Week 24, the study provided valuable insight into the effect of trifarotene on AIH. These exit interviews offer a deeper understanding of the burden of AIH, perceived changes, and treatment satisfaction from the patient ’ s perspective. The results provide evidence for trifarotene as a potential treatment option to help improve AIH and its associated impact."

Clinical • P4 data • Acne Vulgaris