"Trifarotene"

Trifarotene (acne vulgaris) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Trifaroten (Acne vulgaris) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 November 2020). Please note: This translation is provided as a service by IQWiG to English-language readers . However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. A20-73 Trifarotene (acne vulgaris) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A20-73 Version 1.0 Trifarotene (acne vulgaris) 12 November 2020 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details

Trifarotene (Aklief) - acne vulgaris Published 12 September 2022 Product update SMC 2441 trifarotene 50 microgram/g cream (Aklief®) Galderma Ltd 14 January 2022 (Issued 05 August 2022) The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and, following review by the SMC executive, advises NHS Boards and Area Drug and Therapeutics Committees (ADTCs ) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following an abbreviated submission trifarotene (Aklief®) is accepted for use within NHSScotland. Indication under review: for the cutaneous treatment of acne vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and pustules are present. Trifarotene provides an additional

Trifarotene (Aklief) - topical treatment of acne vulgaris Search Page - Drug and Health Product Register * Skip to main content * Skip to "About this site"Language selection * FrançaisGovernment of CanadaSearch and menus * Search and menusSearchSearch websiteSearchTopics menu * Jobs * Immigration * Travel * Business * Benefits * Health * Taxes * More servicesYou are here: 1. HomeSummary Basis

Trifarotene Terms of use - Canada.ca * Skip to main content * Skip to "About government" Language selection * FrançaisSearchSearch Canada.ca Search Topics menuMain Menu You are here: 1. Home 2. Health 3. Drug and health products 4. Licensing, authorizing and manufacturing drug and health products 5. Drug and health product review and approval 6. Clinical information on drugs and health

Trifarotene (Aklief) - acne vulgaris Drug Approval Package: AKLIEF * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood

A review of the topical management of acne and its associated sequelae in the Asia-Pacific region with a spotlight on trifarotene. Acne, a highly prevalent skin disease, can be particularly bothersome for patients of Asian background because of its impact on self-confidence and social interactions. In addition to active acne lesions, some patients may develop sequelae such as scarring, macular treatment efficacy and adherence, we discuss topical retinoids and retinoid combination options in the acne armamentarium that may be beneficial for sequelae prevention and management, such as adapalene 0.3% ± benzoyl peroxide 2.5%, tretinoin 0.05%, tazarotene 0.1%, and trifarotene 0.005%. In particular, trifarotene 0.005% has been observed to significantly reduce acne scar counts in a Phase 4 study

Importance of treating acne sequelae in skin of color: 6-month phase IV study of trifarotene with an appropriate skincare routine including UV protection in acne-induced post-inflammatory hyperpigmentation. Acne-induced hyperpigmentation (AIH) may accompany acne vulgaris (AV) inflammation in all skin phototypes. Trifarotene has shown depigmenting properties in vivo. This study evaluated trifarotene plus skincare because it is increasingly recognized that holistic AV management should include skincare and treatments. This is a phase IV double-blind, parallel-group study of patients (13-35 years) with moderate AV and AIH treated with trifarotene (N = 60) or vehicle (N = 63) plus skincare regimen (moisturizer, cleanser, and sunscreen) for 24 weeks. Assessments included the AIH overall disease

Low Irritation Potential of Tazarotene 0.045% Lotion: Head-to-Head Comparison to Adapalene 0.3% Gel and Trifarotene 0.005% Cream in Two Studies. Irritation with topical retinoids presents a significant impediment to acne treatment adherence. Two studies assessed the irritation potential of tazarotene 0.045% lotion versus adapalene 0.3% gel and trifarotene 0.005% cream. In two double-blind, 12 -day modified cumulative irritation patch studies, healthy adults (N = 20 each) had two active patches, containing 0.1 cc of tazarotene 0.045% lotion and either adapalene 0.3% gel (Study 1) or trifarotene 0.005% cream (Study 2), and one control patch (no product) placed on their upper back. Skin irritation was assessed and patches were replaced every 2-3 days. In Study 1, tazarotene 0.045% lotion

Trifarotene Reduces Risk for Atrophic Acne Scars: Results from A Phase 4 Controlled Study. Atrophic acne scarring often accompanies acne vulgaris. The efficacy of topical retinoids for treatment of acne is well documented; however, evidence for use in atrophic acne scars is limited. In this randomized, split-face, double-blind study, subjects (age: 17-34 years, N = 121) with moderate-to-severe facial acne, with acne scars present, were treated with either trifarotene 50 μg/g or vehicle once daily for 24 weeks. Efficacy was assessed by absolute and percent change from baseline in atrophic acne scar counts, Scar Global assessment (SGA), and IGA success rates as well as acne lesion counts. At week 24, a statistically significantly greater reduction in the mean absolute change from baseline

Acne characteristics in Latin American patients and the potential role of trifarotene. Individualization of treatment based on acne type and severity, location, disease burden, and patient preference is required to maximize efficacy, safety, and adherence to therapy. Latin American populations have unique attributes that must be considered as part of this process to improve clinical success that target the inflammatory processes that underlie acne and its sequelae. As a class, retinoids offer a spectrum of activity that may be useful in addressing the unique needs of Latin American populations. Trifarotene, a novel, selective retinoid, has been evaluated in relevant patient populations.

A Randomized, Controlled Trial of Trifarotene Plus Doxycycline for Severe Acne Vulgaris. We evaluated the efficacy and safety of trifarotene plus oral doxycycline in acne. This was a randomized (2:1 ratio) 12-week, double-blind study of once-daily trifarotene cream 50µg/g plus enteric-coated doxycycline 120mg (T+D) versus trifarotene vehicle and doxycycline placebo (V+P). Patients were aged 12

Trifarotene An official website of the United States government Here's how you know Log inAccess keysNCBI HomepageMyNCBI HomepageMain ContentMain NavigationBookshelfSearch databaseBooksAll DatabasesAssemblyBiocollectionsBioProjectBioSampleBooksClinVarConserved DomainsdbGaPdbVarGeneGenomeGEO DataSetsGEO ProfilesGTRHomoloGeneIdentical Protein GroupsMedGenMeSHNLM during LactationTrifarotene 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.Drug LevelsMaternal Levels. Relevant published information

Randomized Phase 3 Evaluation of Trifarotene 50 μG/G Cream Treatment Of Moderate Facial And Truncal ACNE. Acne vulgaris often affects the face, shoulders, chest, and back, but treatment of nonfacial acne has not been rigorously studied. Assess the safety and efficacy of trifarotene 50 μg/g cream, a novel topical retinoid, in moderate facial and truncal acne. Two phase III double-blind , randomized, vehicle-controlled, 12-week studies of once-daily trifarotene cream versus vehicle in subjects aged 9 years or older. The primary end points were rate of success on the face, as determined by the Investigator's Global Assessment (clear or almost clear and ≥2-grade improvement), and absolute change from baseline in inflammatory and noninflammatory counts from baseline to week 12. The secondary

Long-term safety and efficacy of trifarotene 50 μg/g cream, a first-in-class RAR-γ selective topical retinoid, in patients with moderate facial and truncal acne. Treatment for both facial and truncal acne has not sufficiently been studied. To evaluate the long-term safety and efficacy of trifarotene in both facial and truncal acne. In a multicentre, open-label, 52-week study, patients with moderate facial and truncal acne received trifarotene 50 μg/g cream (trifarotene). Assessments included local tolerability, safety, investigator and physician's global assessments (IGA, PGA) and quality of life (QOL). A validated QOL questionnaire was completed by the patient at Baseline, Week 12, 26 and 52/ET. Of 453 patients enrolled, 342 (75.5%) completed the study. Trifarotene-related treatment

Nonclinical and human pharmacology of the potent and selective topical retinoic acid receptor-γ agonist trifarotene. First- and third-generation retinoids are the main treatment for acne. Even though efficacious, they lack full selectivity for retinoic acid receptor (RAR) γ, expressed in the epidermis and infundibulum. To characterize the in vitro metabolism and the pharmacology of the novel retinoid trifarotene. In vitro assays determined efficacy, potency and selectivity on RARs, as well as the activity on the expression of retinoid target genes in human keratinocytes and ex vivo cultured skin. In vivo studies investigated topical comedolytic, anti-inflammatory and depigmenting properties. The trifarotene-induced gene expression profile was investigated in nonlesional skin of patients

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 To demonstrate the efficacy, therapeutic equivalence and safety of Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and US Reference Listed Drug, Canadian Reference Product over the placebo control in the treatment of acne vulgaris. A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) to Aklief® Cream (US REFERENCE LISTED DRUG), Aklief Cream (REFERENCE PRODUCT) and each active treatment to a placebo control in the treatment of acne vulgaris.

Efficacy and safety of trifarotene for acne: A systematic review. PROSPERO International prospective register of systematic reviews Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms that the information supplied for this submission is accurate

A comparison of the efficacy of new agents in acne management: Clascoterone, Tazarotene 0.045% and Trifarotene: A Systematic Review and Meta-Analysis PROSPEROInternational prospective register of systematic reviews Print | PDFA comparison of the efficacy of new agents in acne management: Clascoterone, Tazarotene 0.045% and Trifarotene: A Systematic Review and Meta-AnalysisMahek Shergill is provided here.CitationMahek Shergill, Mohannad Abu-Hilal. A comparison of the efficacy of new agents in acne management: Clascoterone, Tazarotene 0.045% and Trifarotene: A Systematic Review and Meta-Analysis. PROSPERO 2023 CRD42023488163 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023488163Review questionWhat is the comparative effectiveness of clascoterone, tazarotene

A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris To demonstrate therapeutic equivalence and safety of Trifarotene cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and AKLIEF® cream in the treatment of acne vulgaris A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Trifarotene Cream 0.005% (Taro

Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris To compare the safety and efficacy of the test (Trifarotene 0.005% cream), placebo (vehicle cream) and reference AKLIEF® (Trifarotene 0.005% cream) treatments to demonstrate clinical equivalence in subjects with acne vulgaris. To compare the safety of Test, Reference, and Placebo