The objectives of this research are to demonstrate the following:1. To demonstrate improvement in hair growth and hair appearance following 12 weeks of once daily treatment with tazarotene/halobetasol lotion in patients with moderate to severe scalp psoriasis.2. To demonstrate improvement in scalp itch reduction following 12 weeks of once daily treatment with tazarotene/halobetasol lotion in patients with moderate to severe scalp psoriasis.3. To pictorially demonstrate improvement in moderate to severe scalp psoriasis with 12 weeks of once daily treatment with tazarotene/halobetasol lotion.4. To assessment patient perceptions of the value of a lotion in the treatment of moderate to severe scalp psoriasis.

开始日期2023-06-01

申办/合作机构

Ortho Dermatologics

NCT05608499

/ Active, not recruiting临床3期IIT

Efficacy and Safety of Duobrii in the Management of Acne Keloidalis Nuchae (AKN)

Acne keloidalis nuchae (AKN) is one of the chronic forms of scarring folliculitis, affecting predominantly the occipital scalp, seen mostly in men of African descent. Duobrii has the advantage of being the only high potency topical steroid-retinoid combination approved by the FDA with dermatologic indication. Researchers are proposing the off-labeled use of Duobrii for the management of early-mild AKN. The research team hypothesizes that subjects will experience significant clinical improvement in lesion counts. Patients will be followed with visits scheduled at baseline, 4 weeks, 8 weeks, and 12 weeks. During these in-clinic visits, there will be surveys regarding the severity of AKN symptoms, photographs, and clinical assessments.

开始日期2022-10-26

申办/合作机构

Icahn School of Medicine at Mount Sinai

[+1]

NCT05282771

/ Completed早期临床1期

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Halobetasol Propionate and Tazarotene Topical Lotion 0.01%/0.045% (Taro Pharmaceuticals U.S.A., Inc.) to Duobrii® Lotion (Halobetasol Propionate and Tazarotene Lotion), 0.01%/0.045% (Reference Listed Drug) and Both Active Treatments to a Placebo Control in the Treatment of Moderate to Severe Plaque Psoriasis

To evaluate the therapeutic equivalence and safety of halobetasol propionate and tazarotene topical lotion 0.01%/0.045% (Taro Pharmaceuticals U.S.A., Inc.) and Duobrii® Lotion (halobetasol and tazarotene lotion), 0.01%/0.045% (Reference Listed Drug) in the treatment of moderate to severe plaque psoriasis.

开始日期2021-04-16

申办/合作机构

Taro Pharmaceuticals U.S.A., Inc.

100 项与丙酸乌倍他索/他扎罗汀相关的临床结果

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项与丙酸乌倍他索/他扎罗汀相关的文献（医药）

2021-11-01·Skin therapy letter

Fixed Combination Halobetasol Propionate and Tazarotene Lotion for Plaque Psoriasis.

Article

作者: Guenther, Lyn ; Metelitsa, Andrei ; Prajapati, Vimal H

A novel fixed combination lotion containing the super-potent corticosteroid halobetasol propionate 0.01% and retinoid tazarotene 0.045% (Duobrii™) has recently been introduced and indicated for the treatment of moderate to severe plaque psoriasis in adults. Studies have shown that there is synergy between the ingredients and that the product can be safely used intermittently for up to 1 year. Treatment success (i.e., Investigator Global Assessment [IGA] of clear/almost clear [IGA 0/1] and at least a 2-grade improvement from baseline) occurred in 58.8% of participants at some point in a 1-year clinical trial. Persistence of treatment success is common after treatment discontinuation. Most treatment-emergent adverse events are application site reactions, mild to moderate in intensity, and occur primarily during the first 12 weeks. Counselling should be considered to optimize treatment outcomes.

2020-09-01·Annals of Pharmacotherapy

Treating Psoriasis With Halobetasol Propionate and Tazarotene Combination: A Review of Phase II and III Clinical Trials

Review

作者: Bashyam, Arjun M. ; Ramachandran, Vignesh ; Bertus, Brooke ; Feldman, Steven R.

Objective: To review phase II and III clinical trial data to evaluate the efficacy and safety of the halobetasol propionate/tazarotene (HP/TAZ) combination lotion (Duobrii), a medication approved by the Food and Drug Administration in April 2019 for adults with plaque psoriasis. Data Sources: A systematic search (January 2005 to July 2019) of MEDLINE (PubMed) and EMBASE databases was performed using the terms halobetasol, tazarotene, halobetasol/tazarotene, Duobrii, and IDP-118. Study Selection and Data Extraction: Relevant English-language articles reporting on phase II and phase III clinical trials were included. Data from the individual trials were extracted independently and then cross-checked to ensure accuracy. Data Synthesis: HP/TAZ was safe and efficacious compared with HP alone, TAZ alone, or vehicle. More patients achieved treatment success, described as a ≥2-grade improvement on Investigator Global Assessment Scale, over 8 weeks of treatment and at the 4-week follow-up after treatment cessation. The most common adverse events were dermatitis, pain, and pruritus, which occurred more often in the TAZ groups compared with the HP/TAZ cohorts. Relevance to Patient Care and Clinical Practice: The once-daily HP/TAZ combination lotion simplifies psoriasis treatment and may facilitate adherence, which may improve psoriasis outcomes. Conclusions: HP/TAZ combination lotion is efficacious and safe for plaque psoriasis treatment, with more patients achieving end points and fewer side effects than in HP, TAZ, or vehicle-treated controls. Drug synergy may play a role. Importantly, patient adherence to a once-daily combinational therapy is likely to contribute to efficacy.

Skinmed

DUOBRII™ (Halobetasol Propionate and Tazarotene) Lotion for Topical Use: A Newly Approved Combination Corticosteroid and Retinoid Topical Treatment of Plaque Psoriasis in Adults.

Article

作者: Gupta, Aditya K ; Love, Robin P ; Abramovits, William ; Vincent, Kimberly D

项与丙酸乌倍他索/他扎罗汀相关的新闻（医药）

2023-12-18

·BioSpace

DUOBRII(TM) Lotion to Treat Moderate to Severe Plaque Psoriasis Now Available Through Quebec’s Public Drug Plan

LAVAL, QC / ACCESSWIRE / December 18, 2023 /Bausch Health Canada, part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), ("Bausch Health" or the "Company") today announced that DUOBRII™ (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene), the company's novel topical prescription drug for improving the signs and symptoms of plaque psoriasis in adult patients with moderate to severe disease,1 is now available to patients enrolled in Quebec's public drug plan operated by the Régie de l'assurance maladie du Québec (RAMQ). DUOBRII is already available as a benefit on most other public drug plans in the rest of Canada, including the federal government's Non-Insured Health Benefits (NIHB) program, as well as most private drug insurance plans. "It is very good news for Quebecers with plaque psoriasis to have a new topical treatment option available to them through the Quebec public drug plan," said Dr. Steve Mathieu, a dermatologist at Hôpital Saint-Sacrement in Quebec City. "DUOBRII is a combination treatment for people with moderate to severe plaque psoriasis so it is a valuable new addition to our treatment options." DUOBRII is manufactured for distribution throughout Canada and the United States at the Company's Quebec manufacturing facility in Laval. It has been available in Canada by prescription since August 2020. "Bausch Health, Canada is very pleased that DUOBRII is now available to public drug plan beneficiaries in Quebec so they will be able to benefit from this innovative therapy for plaque psoriasis that is manufactured right here in Quebec," said Cees Heiman, Senior Vice-President, Europe and Canada, Bausch Health. "We want to help Quebecers with moderate to severe plaque psoriasis to achieve their goal of a clear skin." About DUOBRII DUOBRII works in a unique way by combining halobetasol propionate, which reduces inflammation, and tazarotene that contributes to the normalization of skin cell growth. These well-known ingredients have long-established efficacy pro When halobetasol propionate and tazarotene are administered together in DUOBRII, they provide complementary effects due to their individual modes of action targeting different receptors and pathways to achieve anti-inflammatory control and epidermal morphologic restoration. The improvement that is seen in psoriatic patients appears to occur in association with the restoration of normal cutaneous morphology and the reduction of the inflammatory markers ICAM-1 and HLA-DR.2 DUOBRII is also distinct based on its Prismatrex™ technology, a polymeric emulsification system which provides a stable condition where emulsion droplets retained their distribution across time and temperature.3 About Psoriasis Psoriasis is a common, chronic and life-altering skin disease that affects approximately one million Canadians, with 90% of those affected suffering from plaque psoriasis.4 Plaque psoriasis disease is characterized by red elevated patches and flaking silvery scales, and symptoms can range from mild to severe. While the plaques can appear anywhere on the body, the most common places include the elbows, knees, scalp, chest and lower back. Because the disease typically affects visible parts of the body, the impact on patients extends well beyond the physical symptoms. Psoriasis can impact nearly every aspect of an individual's life including their ability to work and maintain social and intimate relationships. In addition to the tremendous medical burden experienced while trying to find a medication that controls the disease, the psychological impact is high. Approximately 70 per cent of individuals suffer from low self-confidence and approximately 50 percent of patients experience anxiety, and depression, respectively.5 About Bausch Health Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit and connect with us on Twitter and LinkedIn. Bausch Health, Canada Inc.'s prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at . REFERENCES 1 DUOBRII Product Monograph. Bausch Health, Canada Inc. June 16, 2020, p.3 2 DUOBRII Product Monograph. Bausch Health, Canada Inc. June 16, 2020, p.13. 3 Data in Health Canada New Drug Submission for DUOBRII 4 5 Investor Contact: Media Contact: ir@bauschhealth.com Kevin Wiggins (908) 541-2973 corporate.communications@bauschhealth.com (877) 281-6642 (toll free) (908) 927-1198 SOURCE: Bausch Health Companies Inc. View the original press release on accesswire.com

上市批准

2023-12-18

·ir.bauschhealth.com

DUOBRII™ lotion to treat moderate to severe plaque psoriasis now available through Quebec’s public drug plan

December 18, 2023 LAVAL, QC, December 18, 2023 - Bausch Health, Canada, part of Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), ("Bausch Health" or the "Company") today announced that DUOBRII™ (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene), the company’s novel topical prescription drug for improving the signs and symptoms of plaque psoriasis in adult patients with moderate to severe disease,1 is now available to patients enrolled in Quebec’s public drug plan operated by the Régie de l’assurance maladie du Québec (RAMQ). DUOBRII is already available as a benefit on most other public drug plans in the rest of Canada, including the federal government’s Non-Insured Health Benefits (NIHB) program, as well as most private drug insurance plans. "It is very good news for Quebecers with plaque psoriasis to have a new topical treatment option available to them through the Quebec public drug plan," said Dr. Steve Mathieu, a dermatologist at Hôpital Saint-Sacrement in Quebec City. "DUOBRII is a combination treatment for people with moderate to severe plaque psoriasis so it is a valuable new addition to our treatment options." DUOBRII is manufactured for distribution throughout Canada and the United States at the Company's Quebec manufacturing facility in Laval. It has been available in Canada by prescription since August 2020. “Bausch Health, Canada is very pleased that DUOBRII is now available to public drug plan beneficiaries in Quebec so they will be able to benefit from this innovative therapy for plaque psoriasis that is manufactured right here in Quebec,” said Cees Heiman, Senior Vice-President, Europe and Canada, Bausch Health. “We want to help Quebecers with moderate to severe plaque psoriasis to achieve their goal of a clear skin.” About DUOBRII DUOBRII works in a unique way by combining halobetasol propionate, which reduces inflammation, and tazarotene that contributes to the normalization of skin cell growth. These well-known ingredients have long-established efficacy profiles. When halobetasol propionate and tazarotene are administered together in DUOBRII, they provide complementary effects due to their individual modes of action targeting different receptors and pathways to achieve anti-inflammatory control and epidermal morphologic restoration. The improvement that is seen in psoriatic patients appears to occur in association with the restoration of normal cutaneous morphology and the reduction of the inflammatory markers ICAM-1 and HLA-DR.2 DUOBRII is also distinct based on its Prismatrex™ technology, a polymeric emulsification system which provides a stable condition where emulsion droplets retained their distribution across time and temperature.3 About Psoriasis Psoriasis is a common, chronic and life-altering skin disease that affects approximately one million Canadians, with 90% of those affected suffering from plaque psoriasis.4 Plaque psoriasis disease is characterized by red elevated patches and flaking silvery scales, and symptoms can range from mild to severe. While the plaques can appear anywhere on the body, the most common places include the elbows, knees, scalp, chest and lower back. Because the disease typically affects visible parts of the body, the impact on patients extends well beyond the physical symptoms. Psoriasis can impact nearly every aspect of an individual's life including their ability to work and maintain social and intimate relationships. In addition to the tremendous medical burden experienced while trying to find a medication that controls the disease, the psychological impact is high. Approximately 70 per cent of individuals suffer from low self-confidence and approximately 50 percent of patients experience anxiety, and depression, respectively.5 About Bausch Health Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter (X) and LinkedIn. Bausch Health, Canada Inc.’s prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at www.bauschhealth.ca REFERENCES 1 DUOBRII Product Monograph. Bausch Health, Canada Inc. June 16, 2020, p.3 2 DUOBRII Product Monograph. Bausch Health, Canada Inc. June 16, 2020, p.13. 3 Data in Health Canada New Drug Submission for DUOBRII 4 https://www.canadianpsoriasisnetwork.com/psoriasis/forms-of-psoriasis/ 5 https://www.canadianpsoriasisnetwork.com/wp-content/uploads/2020/06/Fact_Sheet_Rheumatologists_Psoriasis_Journey_to_Stability_8-5x11_EN_x1a_bleed.pdf Investor Contact: Media Contact: ir@bauschhealth.com Kevin Wiggins (908) 541-2973 corporate.communications@bauschhealth.com (877) 281-6642 (toll free) (908) 927-1198 << Back to News Releases

上市批准

2022-12-02

·ir.bauschhealth.com

Bausch Health Wins DUOBRII® and BRYHALI® Patent Infringement Case

LAVAL, QC / ACCESSWIRE / December 2, 2022 / Bausch Health Companies Inc. (NYSE/TSX: BHC) today announced that the US District Court for the District of New Jersey issued a favorable decision regarding DUOBRII® and BRYHALI®, in a suit filed against Padagis Israel Pharmaceuticals LTD and Padagis US LLC. According to the ruling, the District Court found all the asserted patents valid and infringed. The current decision will serve to prevent approval of Padagis BRYHALI® and DUOBRII® generics until patent expiry in 2031 and 2036, respectively. DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, is a prescription medicine used on the skin (topical) to treat adults with plaque psoriasis. BRYHALI® (halobetasol propionate) Lotion, 0.01% is a prescription medicine used on the skin (topical) to treat adults with plaque psoriasis. Seana Carson, Executive Vice President and General Counsel stated, “We are pleased with this outcome. This decision is a reflection of the strength of our intellectual property, and our commitment to defending our patent portfolio.” About Bausch Health Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn. Forward-looking Statements This news release may contain forward-looking statements about the future performance of Bausch Health which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Investor Contact: Christina Cheng ir@bauschhealth.com (514) 856-3855 (877) 281-6642 (toll free) Media Contact: Kevin Wiggins corporate.communications@bauschhealth.com (908) 541-3785

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	D05	-

研发状态

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适应症	国家/地区	公司	日期
斑块状银屑病	加拿大	Valeant Canada Ltd.	-

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适应症	最高研发状态	国家/地区	公司	日期
瘢瘤性痤疮	临床3期	美国	Bausch Health Americas, Inc.	2022-10-26

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04720105 (CTgov)	临床4期	斑块状银屑病 \| 肢端弹力样变	22	Duobrii®	築積願簾築糧願網網夢(鑰壓願觸鏇壓鹹廠製鑰) = 選觸鏇簾糧餘廠膚範鑰構築憲壓窪願憲顧夢鹽 (壓鹽簾構積鑰憲築窪鏇, 築夢蓋餘鏇襯鑰憲簾淵 ~ 構願膚繭淵窪壓鹹獵糧) 更多	-	2023-10-27
NCT02785172 (CTgov)	临床2期	斑块状银屑病	154	IDP-118 Lotion (IDP-118 Lotion)	衊艱窪膚鬱夢窪製膚齋(獵鏇鹹顧齋蓋憲齋糧遞) = 餘遞製簾築膚餘選鑰製窪廠夢醖構選鹽艱築淵 (蓋觸鏇廠鬱獵衊鑰齋餘, 襯鏇積憲壓膚淵築憲壓 ~ 艱鏇簾鬱築鏇網糧選壓) 更多	-	2020-08-20
				Ultravate Cream (Ultravate Cream)	衊艱窪膚鬱夢窪製膚齋(獵鏇鹹顧齋蓋憲齋糧遞) = 簾餘醖築衊鑰鏇醖顧鑰窪廠夢醖構選鹽艱築淵 (蓋觸鏇廠鬱獵衊鑰齋餘, 構齋獵觸襯窪鹽製網艱 ~ 範築願壓網網築衊獵觸) 更多
NCT02785159 (CTgov)	临床2期	斑块状银屑病	152	IDP-118 Lotion (IDP-118 Lotion)	繭遞壓顧觸製網選選製(積鬱顧簾憲願範顧襯製) = 遞膚憲艱築糧選簾淵觸窪衊願網鑰鏇選構糧廠 (獵衊選醖襯醖顧窪築簾, 製鹽鬱鏇蓋鑰顧壓憲獵 ~ 憲廠觸憲願餘選鑰獵醖) 更多	-	2020-08-20
				Tazorac Cream (Tazorac Cream)	繭遞壓顧觸製網選選製(積鬱顧簾憲願範顧襯製) = 鬱鏇糧顧網築襯築積窪窪衊願網鑰鏇選構糧廠 (獵衊選醖襯醖顧窪築簾, 鑰構廠簾齋齋構齋餘顧 ~ 製襯鹹繭膚蓋壓製簾淵) 更多