A prospective, multi center, open label phase IV clinical study to evaluate the safety and efficacy of Trifarotene or Aklief 50 microgram per gram cream in subjects with acne vulgaris over 12 weeks. - NIL

Start Date26 Aug 2024

Sponsor / Collaborator

Galderma SA (Switzerland)

[+1]

NCT06063473 / CompletedPhase 1

A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) and to AKLIEF® Cream (Trifarotene 0.005%,Galderma) and Both Active Treatments to a Placebo Control 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

Start Date22 Feb 2023

Sponsor / Collaborator

Taro Pharmaceuticals U.S.A., Inc.

NCT05550337 / CompletedPhase 3

A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, THREE-ARM, PLACEBO CONTROLLED, PARALLEL-DESIGN GROUP STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE COMPARING TRIFAROTENE CREAM, 0.005% (TEVA PHARMACEUTICALS, INC. TO AKLIEF ® (TRIFAROTENE 0.005% CREAM) (GALDERMA LABORATORIES, L.P., USA), 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.

Start Date19 Sep 2022

Sponsor / Collaborator

Teva Pharmaceuticals USA, Inc.

[+1]

100 Clinical Results associated with Trifarotene

100 Translational Medicine associated with Trifarotene

100 Patents (Medical) associated with Trifarotene

Literatures (Medical) associated with Trifarotene

30 Jul 2024·Cureus Journal of Medical Science

Role of Trifarotene in the Management of Acne in Indian Patients: Insights From an Indian Dermatology Experts' Meeting

Review

Author: Madnani, Nina ; Tiwari, Anurag ; Das, Anupam ; Satish, D A ; Tahiliani, Sushil T ; Sen, Dyotona ; Damisetty, Rajetha ; Jadhwar, Sameer ; Saraswat, Abir ; Aurangabadkar, Sanjeev ; D S, Krupashankar

Acne vulgaris, a prevalent inflammatory skin condition, significantly impacts individuals worldwide, particularly adolescents and adults. Its chronic nature, associated sequelae, and psychosocial impact underscore the substantial burden it poses. Current treatment guidelines primarily address facial acne, with limited guidance on managing truncal acne. Personalized approaches are increasingly recognized as essential for tailoring treatments to individual patient needs. This review integrates insights from an Indian Dermatology Experts' Meeting, featuring perspectives from nine leading dermatologists. Discussions centered on analyzing acne's burden, its effects on quality of life (QoL), unmet needs in management, trifarotene's role in Indian therapy, anticipated challenges, and the importance of ancillary care. The experts highlighted acne's profound impact on patients' QoL and identified gaps in current management guidelines, especially concerning truncal acne. Trifarotene, a fourth-generation topical retinoid approved by the FDA and Drug Controller General of India (DCGI) for facial and truncal acne, demonstrated safety and efficacy across age groups. This synthesis of expert perspectives underscores the need for personalized acne management. Trifarotene emerges as a promising therapeutic option but challenges remain, particularly in optimizing ancillary care to minimize treatment-related adverse effects. Addressing these issues will enhance treatment outcomes and patient satisfaction in acne management, emphasizing the importance of tailored approaches in clinical practice.

01 Jul 2024·Skin therapy letter

An Overview on the Management of Atrophic Acne Scars: The Role of Trifarotene as an Adjunct.

Review

Author: Conte, Santina ; Li, Monica K

Acne vulgaris is a common, often chronic inflammatory disease that can affect all ages and skin tones. Beyond acute lesions, the sequelae of acne - specifically scarring and dyspigmentation - can be long-lasting, challenging to treat and have substantial psychosocial impact on affected individuals. For acne scarring, treatment modalities include topical, physical, and laser and light therapies, with combination approaches typically yielding optimal outcomes. Trifarotene is a novel fourth generation retinoid with targeted action towards retinoid acid receptor gamma (RAR-γ), the most common isotype found in the epidermis, that has previously been approved for the management of moderate-to-severe facial and truncal acne in individuals over the age of 12 years. Recently, data on trifarotene supports its application in acne scarring. Herein, we provide a succinct review on various treatments for acne scarring and explore how trifarotene and its mechanism of action present an additional topical approach to target atrophic acne scarring.

01 Jun 2024·INTERNATIONAL JOURNAL OF DERMATOLOGY

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

Article

Author: Del Rosso, James Q. ; York, Jean Philippe ; Dhawan, Sunil ; Laquer, Vivian ; Moore, Angela Y. ; Chavda, Rajeev ; Desai, Seemal R. ; Martorell, Antonio ; Stein‐Gold, Linda ; Alexis, Andrew ; Browning, John ; Forman, Seth

Abstract:

Background:

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.

Methods:

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 severity (ODS) score, post‐AV hyperpigmentation index (PAHPI), exit interviews, photography, and acne assessments. Standard safety assessments were included.

Results:

Trifarotene 50 μg/g cream improved significantly from baseline in ODS score versus vehicle (−1.6 vs. −1.1, P = 0.03) at Week 12, but scores were comparable between groups at Week 24 (primary endpoint). Trifarotene had a better reduction in PAHPI score at Week 24 (−18.9% vs. −11.3% vehicle, P < 0.01). Lesion count reductions were higher with trifarotene at Week 12 versus vehicle (P < 0.001) and at Week 24 (P < 0.05), as were IGA success rates versus vehicle at Weeks 12 (P < 0.05) and 24 (P < 0.05). Patients agreed that the skincare regimen contributed to less irritation, making treatment adherence easier. Photography showed improvements in pigmentation and erythema across all skin types. AEs were more common in the vehicle group versus trifarotene (30.2 vs. 16.7%, respectively).

Conclusions:

In all skin phototypes, there was more rapid improvement in the ODS and PAHPI scores with trifarotene by Weeks 12 and 24, respectively. The combination of trifarotene and skincare correlated with high patient satisfaction and adherence to the treatment protocol.

News (Medical) associated with Trifarotene

28 Feb 2024

·www.biospace.com

Galderma to Showcase Latest Updates From Its Broad, Innovative and Leading Dermatology Portfolio at the 2024 American Academy of Dermatology Annual Meeting

Galderma will present two late-breaking presentations on clinical trials evaluating the long-term efficacy of the investigational monoclonal antibody nemolizumab in prurigo nodularis and its durability in atopic dermatitis1,2 Five oral posters and 16 e-posters will also be presented from across Galderma’s aesthetic, therapeutic dermatology and dermatological skincare portfolio, with data on acne, sensitive skin, aesthetic improvements and prurigo nodularis For the first time, Galderma will sponsor a symposium on the burden of itch in collaboration with the U.S. National Eczema Association, featuring renowned dermatology experts along with patient representatives ZUG, Switzerland--(BUSINESS WIRE)-- Galderma, the pure-play dermatology category leader, will be showcasing its latest clinical and educational efforts at the American Academy of Dermatology (AAD) Annual Meeting from March 8-12, 2024, highlighting its broad, innovative and leading dermatology portfolio. Galderma’s extensive presence – including two late-breaking presentations on its first-in-class, investigational monoclonal antibody nemolizumab, five oral poster presentations, 16 e-posters, a symposium, and several ‘Meet the Expert’ and interactive booth sessions – highlights its commitment to listening to consumers, patients and healthcare professionals in order to deliver cutting-edge science and innovation that addresses their varied needs. “Our vast presence at AAD combines new data, novel educational activities and patient perspectives, demonstrating how we are putting our commitment to addressing the needs of the dermatology community into action. We particularly look forward to presenting the latest updates from clinical trials of nemolizumab, which was recently accepted for filing by regulatory authorities in the U.S. and EU in prurigo nodularis and atopic dermatitis.” BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA Data from across the full spectrum of dermatology to be presented New data on nemolizumab, a first-in-class, investigational monoclonal antibody specifically designed to provide safe and rapid relief from itch, will be shared at AAD in two late-breaking presentations: Results up to 52 weeks from an interim analysis of the OLYMPIA open-label extension study evaluating the long-term efficacy and safety of nemolizumab in patients with prurigo nodularis will be presented on Sunday, March 10, at 3:20 PM PST by Dr. Shawn Kwatra1 Results from an analysis of two pivotal phase III studies (ARCADIA 1 and ARCADIA 2) evaluating the efficacy and safety of maintenance treatment with nemolizumab at 48 weeks in patients with moderate to severe atopic dermatitis will be presented on Sunday, March 10, at 2:50 PM PST by Dr. Jonathan Silverberg2 Additionally, five oral posters will be presented on Friday, March 08, at the Upper Level, Sails Pavilion, Poster Center 1, including: Results from the phase III READY-3 study evaluating the efficacy and safety of RelabotulinumtoxinA, our investigational novel, ready-to-use liquid neuromodulator, when used for combination treatment of frown lines (glabellar lines) and crow’s feet (lateral canthal lines) at 9:50 to 9:55 AM PST, presented by Dr. Joel Schlessinger3 Results from the phase IV LEAP and START studies, showing that trifarotene improves acne and related sequelae at 9:05 to 9:10 AM PST, and that it is efficacious and suitable for a broad range of patient types at 8:35 to 8:40 AM PST, both presented by Dr. Andrew Alexis4,5 Survey results on sensitive skin, including on dermatologists’ perspectives and educational exposures at 3:50 to 3:55 PM PST, presented by Dr. Sara Abdel Azim, and primary hyperhidrosis and sensitive skin syndrome at 10:10 to 10:15 AM PST, presented by Dr. Cleo Whiting6,7 Delving into patient and expert perspectives on itch Our sponsored symposium, Perspectives on itch: Sharing experiences and understanding the burden, conducted in collaboration with the National Eczema Association, will bring together leading experts and patient representatives, Dr. Shawn Kwatra, Dr. Jonathan Silverberg, Dr. Matt Zirwas, and from the U.S. National Eczema Association, Wendy Begolka, to explore how dermatology providers can better recognize and address itch, one of the most burdensome and debilitating symptoms associated with diseases such as atopic dermatitis and prurigo nodularis. The event is taking place on Saturday, March 9, in the Pacific Ballroom 21-26, Marriott Marquis San Diego Marina, from 7:00 to 9:00 PM PST. More details on Galderma’s scientific presentations at AAD can be found here. *All presenters are paid consultants or employees of Galderma. About Galderma Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market though Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: . References Kwatra, S, et al. Nemolizumab long-term efficacy and safety up to 52 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: an interim analysis. Late-breaking abstract presented at AAD 2024. Silverberg, J, et al. Maintenance of efficacy and safety with nemolizumab at Week 48: results from two global phase III pivotal studies (ARCADIA 1 and ARCADIA 2) in patients with moderate-to-severe atopic dermatitis. Late-breaking abstract presented at AAD 2024. Schlessinger, S, et al. Efficacy and safety of a novel formulation liquid botulinum toxin, RelabotulinumtoxinA, when used for combination treatment of glabellar and lateral canthal lines. Oral poster presented at AAD 2024. Alexis, A, et al. Trifarotene shown to improve acne and related sequelae. Oral poster presented at AAD 2024. Alexis, A, et al. Phase IV studies show trifarotene is efficacious and suitable for broad range of patient types. Oral poster presented at AAD 2024. Azim, SA, et al. Sensitive skin: a survey of dermatology resident physicians’ perspectives and educational exposures. Oral poster presented at AAD 2024. Whiting, C, et al. Primary hyperhidrosis and sensitive skin syndrome: a national pilot survey. Oral poster presented at AAD 2024. View source version on businesswire.com: Contacts Christian Marcoux, M.Sc. Chief Communications Officer christian.marcoux@galderma.com +41 76 315 26 50 Sébastien Cros Corporate Communications Director sebastien.cros@galderma.com +41 79 529 59 85 Emil Ivanov Head of Strategy, Investor Relations, and ESG emil.ivanov@galderma.com +41 21 642 78 12 Jessica Cohen Investor Relations and Strategy Director jessica.cohen@galderma.com +41 21 642 76 43 Source: Galderma View this news release online at:

Phase 3

31 Jan 2024

·www.prnewswire.com

AMERICAN ACADEMY OF DERMATOLOGY ISSUES UPDATED GUIDELINES FOR THE MANAGEMENT OF ACNE

Both newly approved and well-established treatments recommended ROSEMONT, Ill., Jan. 31, 2024 /PRNewswire/ -- Acne is the most common skin condition in the United States, affecting nearly 50 million Americans each year, with symptoms usually beginning in puberty. Acne affects 85% of adolescents and can also often begin or continue in adulthood, especially in women. To help ensure that people with acne get the best possible treatment, the American Academy of Dermatology (AAD) has published updated guidelines of care for the management of acne in adults, adolescents, and children over the age of 9 in the Journal of the American Academy of Dermatology. Continue Reading "These guidelines provide important updates to the 2016 AAD acne guidelines, including discussion of new topical medications, which are directly applied to the skin, and systemic treatments, which are taken by mouth," said board-certified dermatologist John S. Barbieri, MD, MBA, FAAD, co-chair of the AAD's Acne Guideline Workgroup. "This update provides evidence-based recommendations for dermatologists and other clinicians caring for patients with acne." Acne affects 85% of adolescents and can also often begin or continue in adulthood, especially in women. Post this Updates to the management of acne vulgaris provides 18 evidence-based recommendations for topical, systemic, and physical treatment methods, including newly approved therapeutic options, and 5 good practice statements. Strong recommendations were made for the use of the following: Topical benzoyl peroxide to reduce the amount of acne-causing bacteria on the skin. Topical retinoids (e.g. adapalene, tretinoin, tazarotene, trifarotene) to help unclog pores and reduce inflammation. Oral antibiotics, such as oral doxycycline, and topical antibiotics to reduce the amount of acne-causing bacteria on the skin and lessen inflammation. Combinations of topical benzoyl peroxide, retinoids, or the above antibiotics. Employing best practices in guideline development, the multidisciplinary workgroup also issued 5 good practice statements. When managing acne with topical medications, the guidelines recommend combining multiple different treatment types, as this can lead to better results. The guidelines recommend limiting use of oral antibiotics when possible to reduce the development of antibiotic resistance and other antibiotic-associated complications. It is recommended that topical and oral antibiotics are used simultaneously with benzoyl peroxide to prevent the development of antibiotic resistance. For patients with larger acne bumps, the guidelines recommend injectable corticosteroids as a potential option for more rapid relief of inflammation and pain. For patients with severe acne or for patients who have failed standard treatment with oral or topical therapy, the guidelines recommend isotretinoin. Additionally, the guidelines provide conditional recommendations. Conditional recommendations apply to most patients, but the most appropriate action may differ depending on individual patient factors. Topical clascoterone, which addresses hormonal causes of acne. Topical salicylic acid to unclog pores and exfoliate the skin. Topical azelaic acid to unclog pores, kill bacteria, and fade dark spots that may continue when an acne spot clears. Oral minocycline or sarecycline to reduce the amount of acne-causing bacteria on the skin and lessen inflammation. Hormonal therapies such as combined oral contraceptives or spironolactone to address hormonal causes of acne. Available evidence was insufficient to develop recommendations for procedures such as chemical peels, laser and light-based devices, microneedling, as well as for dietary changes, or alternative therapies such as vitamins or plant-based products. Additionally, a conditional recommendation against adding broadband light, intense pulsed light, to adapalene 0.3% gel. "Board-certified dermatologists are on the forefront of new and exciting advances in the treatment of acne," said Dr. Barbieri. "We are able to offer our patients with acne more options than ever before as we work to address their concerns and determine the most effective treatment plan possible. Just as important, dermatologists must have access to all available therapeutic options." Since there are a variety of treatment options for acne and treatment plans are not one-size-fits-all, it is important to partner with a board-certified dermatologist to decide which options work best for you. To find a board-certified dermatologist in your area, visit aad.org/findaderm. More Information Acne resource center Acne treatment AAD B-Roll Library About the AAD Headquartered in Rosemont, Ill., the American Academy of Dermatology, founded in 1938, is the largest, most influential and most representative of all dermatologic associations. With a membership of more than 20,800 physicians worldwide, the AAD is committed to advancing the diagnosis and medical, surgical, and cosmetic treatment of the skin, hair, and nails; advocating high standards in clinical practice, education and research in dermatology; and supporting and enhancing patient care because skin, hair, and nail conditions can have a serious impact on your health and well-being. For more information, contact the AAD at (888) 462-DERM (3376) or aad.org. Follow @AADskin on Facebook, TikTok, Pinterest and YouTube and @AADskin1 on Instagram. SOURCE American Academy of Dermatology

13 Oct 2023

·www.biospace.com

Galderma Unveils Bold Ambition in Neuromodulation at Liquid Live Event

At the Liquid Live event in Dubai, the Company gears up for launch of Alluzience® in next wave of countries and presents exciting pipeline update ZUG, Switzerland--(BUSINESS WIRE)-- Galderma, the emerging pure-play dermatology category leader, today hosts the first edition of its Liquid Live event in Dubai as a chance to discuss with clinicians the future of innovation in the field of neuromodulation as well as showcasing the latest neuromodulators from its aesthetics portfolio. This press release features multimedia. View the full release here: Copyrights - Sylvain Granjon To mark the progress in treatment optimization and showcase its commitment to further driving innovation, Galderma has organized the first ever Liquid Live event. This premium experience will convene over one hundred of Europe’s leading aesthetics practitioners to immerse themselves in the future of the neuromodulator field. The Liquid Live event will include presentations from renowned experts on key data, the latest market trends and changes in patient needs, and sharing insights to advance the future of neuromodulation in aesthetics together. A year on from the launch of Alluzience®, the first and only liquid ready-to-use neuromodulator in Europe with rapid onset and effects lasting for up to six months, Galderma is now getting ready to launch the product in 13 new countries1. Indicated for use in adult patients as a treatment to temporarily improve the appearance of moderate to severe glabellar lines, this launch opened a new era of innovation in neuromodulation. As a ready-to-use liquid formulation, it has the potential to improve safety and dosing accuracy compared to existing neuromodulators that require reconstitution, enabling more precision and higher patient satisfaction. “Galderma is the leading innovator in neuromodulators and we are delighted to launch the Liquid Live event as an opportunity to convene leading experts in this field. Alluzience® has a unique pro its launch in 13 new countries is another exciting step in our journey of driving differentiated innovation and expanding our portfolio. Galderma has a strong track record as an innovator in neuromodulation having launched the first liquid neuromodulator, as well as the first neuromodulator with a six-month duration of action, and is committed to further innovation. Liquid Live offers the ideal platform for us to come together as we prepare to launch this unique product more broadly and explore the many possibilities for the future of neuromodulation together.” GERRY MUHLE HEAD OF GLOBAL PRODUCT STRATEGY GALDERMA Galderma is well-positioned to continue to build its category-leading pipeline in injectable aesthetics, with proven in-house R&D capabilities in medical aesthetics. This includes successfully developing RelabotulinumtoxinA internally as well as the world’s largest hyaluronic acid filler range, Restylane®. Along with Sculptra®, the first and original injectable poly-L-lactic acid collagen stimulator, Galderma’s offering in neuromodulators and fillers is the broadest, unparalleled injectable aesthetics portfolio. About Alluzience® Alluzience (abobotulinumtoxinA solution) is the first ready-to-use BoNT-A liquid neuromodulator formulation to be introduced in Europe. Alluzience is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines seen at maximum frown in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient. It should only be administered by a physician with appropriate qualifications and expertise in this treatment using the required equipment. Dosing and treatment intervals depend on assessment of the individual patient’s response. The treatment interval should be no more frequent than every three months. For more information, please see the Summary of Product Characteristics2. Alluzience is a product under license from Ipsen. Alluzience is a registered trademark of Ipsen. Galderma has an exclusive license from Ipsen to develop, promote and distribute Alluzience in the approved indication in Europe. About Galderma Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market though Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. Galderma’s portfolio of flagship brands includes Restylane®, Dysport®, Azzalure®, Alluzience® and Sculptra® in Injectable Aesthetics; Soolantra®, Epiduo®, Differin®, Aklief®, Epsolay®, Twyneo®, Oracea®, Metvix®, Benzac® and Loceryl® in Therapeutic Dermatology; and Cetaphil® and Alastin Skincare® in Dermatological Skincare. For more information: ---------------- 1 Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Malta, Romania, Slovenia and Slovakia 2 Alluzience Summary of Product Characteristics, 2023 View source version on businesswire.com: Contacts For further information: Christian Marcoux, M.Sc. Chief Communications Officer christian.marcoux@galderma.com +41 76 315 26 50 Sébastien Cros Corporate Communications Director sebastien.cros@galderma.com +41 79 529 59 85 Emil Ivanov Head of Strategy, Investor Relations, and ESG emil.ivanov@galderma.com +41 21 642 78 12 Jessica Cohen Investor Relations and Strategy Director jessica.cohen@galderma.com +41 21 642 76 43 Source: Galderma Smart Multimedia Gallery Photo Copyrights - Sylvain Granjon Photo Copyrights - Sylvain Granjon Photo Copyrights - Sylvain Granjon Logo View this news release and multimedia online at:

License out/in

100 Deals associated with Trifarotene

External Link

KEGG	Wiki	ATC	Drug Bank
D11225	Trifarotene	D10AD06	DB12808

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acne Vulgaris	US	Galderma Laboratories LP	04 Oct 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Autosomal recessive ichthyosis	Phase 2	US	Mayne Pharma International Pty Ltd.	01 May 2019
Autosomal recessive ichthyosis	Phase 2	AU	Mayne Pharma International Pty Ltd.	01 May 2019
Autosomal recessive ichthyosis	Phase 2	CA	Mayne Pharma International Pty Ltd.	01 May 2019
Autosomal recessive ichthyosis	Phase 2	FR	Mayne Pharma International Pty Ltd.	01 May 2019
Autosomal recessive ichthyosis	Phase 2	DE	Mayne Pharma International Pty Ltd.	01 May 2019
Autosomal recessive ichthyosis	Phase 2	IL	Mayne Pharma International Pty Ltd.	01 May 2019
Autosomal recessive ichthyosis	Phase 2	ES	Mayne Pharma International Pty Ltd.	01 May 2019
Autosomal recessive ichthyosis	Phase 2	UA	Mayne Pharma International Pty Ltd.	01 May 2019
Autosomal recessive ichthyosis	Phase 2	GB	Mayne Pharma International Pty Ltd.	01 May 2019
Ichthyosis, Lamellar	Phase 2	US	Mayne Pharma International Pty Ltd.	01 May 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05550337 (CTgov)	Phase 3	Acne Vulgaris	807	Trifarotene 0.005 % Topical Cream (Test: Trifarotene Cream, 0.005%)	bkkxivbdww(ahnvgscpgs) = ibcfyymcbj mylrejhtmk (dhqrwwlybe, hjfrpgnvbg - qhgpvgjose) View more	-	26 Sep 2024
				AKLIEF® (AKLIEF®)	bkkxivbdww(ahnvgscpgs) = hiokdiapah mylrejhtmk (dhqrwwlybe, vkpbekqtvj - nzncctlnuo) View more
NCT04856904 (Phase 4 Controlled Study \| START, CTgov)	Phase 4	Atrophic acne scar \| Acne Vulgaris	121	Trifarotene Vehicle Cream	sduhvaghfk(uwqllkjtss) = ppjrjjugto apejjfxpjd (trmdrcmsog, bwbwgovxuu - biycuvlhdc) View more	-	11 Jun 2024
NCT05089708 (LEAP, CTgov)	Phase 4	Acne Vulgaris	123	Trifarotene Vehicle Cream	fbtsfnsvxn(kehaqkxuff) = gpghaqaxxx pddthxioos (bwrrssafsc, fnsgfbxwpt - ayfzzqwilz) View more	-	20 Dec 2023
NCT04856904 (Phase 4 Controlled Study, Pubmed \| Dermatol Ther (Heidelb))	Phase 4	Atrophic acne scar	121	Trifarotene 50 μg/g	kvbuxarceh(ewruhiwppa) = The incidence of treatment-emergent adverse events was 5.8% (trifarotene) and 2.5% (vehicle); most common (> 1%) was skin tightness (1.7% vs 0.8%), and all events were mild to moderate in severity tlbgsitjqs (edeycdvjby )	Positive	01 Dec 2023
				Vehicle
NCT05089708 (LEAP, EADV2023)	Phase 4	Hyperpigmentation	-	Trifarotene 50µg/g cream	zvgutuwsur(skyingpogc) = oqzomnhpfq mmkhhabgze (lenjpdlrmk ) View more	Positive	11 Oct 2023
				Vehicle cream	zvgutuwsur(skyingpogc) = qtoxxdycco mmkhhabgze (lenjpdlrmk ) View more
The DUAL study (WCD2023)	Not Applicable	Severe acne	202	Trifarotene 50 μg/g cream + oral doxycycline 120 mg	oddtbqpbnh(bwmfisnade) = zlncobqebq hejiqkfslz (cfyaghzvre )	Positive	04 Jul 2023
				Trifarotene vehicle + doxycycline placebo	oddtbqpbnh(bwmfisnade) = fuukhrfzbp hejiqkfslz (cfyaghzvre )
WCD2023	Phase 3	-	-	Trifarotene 0.005% cream	tsqbwxbdkz(ghcyohzght) = vfetzsbudu iunfepoqsx (eexajsugrk )	Positive	03 Jul 2023
				Vehicle	tsqbwxbdkz(ghcyohzght) = vgmveflnds iunfepoqsx (eexajsugrk )
WCD2023	Phase 4	Severe acne	198	Combination therapy	eklxauqgfe(zucpexivaj) = glmmzhhtum rdykniirem (esojhqjsvw ) View more	-	03 Jul 2023
AAD2023	Phase 3	-	-	Trifarotene 0.005% cream	maouuowdsa(rpbrzznbus) = AEs occurred in 28.3% trifarotene group vs 23.5% vehicle-treated and rarely led to study discontinuation (1.9% trifarotene, 0.2% vehicle) gbtlkghezq (lbtlxzvozy ) View more	Positive	17 Mar 2023
				Vehicle
EADV2022	Phase 3	Acne Vulgaris	-	Trifarotene cream	myvyttzsog(kaetdojydv) = szejhtiggk yddszouckn (zuvydmtggn ) View more	Positive	07 Sep 2022
				Vehicle	myvyttzsog(kaetdojydv) = ypyyjirgce yddszouckn (zuvydmtggn ) View more

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