A Demonstration of the Anti-Inflammatory Effects of 0.045% Tazarotene/0.01% Halobetasol Lotion as Compared to 0.05% Clobetasol Propionate Cream in the Treatment of Psoriasis

The objective of this research is to demonstrate superior anti-inflammatory effects, as demonstrated by a reduction in TNF-a and IL-17A, with tazarotene/halobetasol lotion in patients with mild to moderate plaque type psoriasis as compared to clobetasol propionate 0.05% cream.

开始日期2023-07-13

申办/合作机构-

NCT05608499

/ Terminated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

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100 项与丙酸乌倍他索相关的转化医学

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100 项与丙酸乌倍他索相关的专利（医药）

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146

项与丙酸乌倍他索相关的文献（医药）

2025-08-01·Journal of Drugs in Dermatology

Resolving Hyperkeratotic Psoriasis: Mechanisms of Action and Additive Effects of Fixed-Combination Halobetasol Propionate and Tazarotene

Review

作者: Draelos, Zoe D. ; Green, Lawrence ; Tanghetti, Emil A. ; Jacobson, Abby ; Lebwohl, Mark G. ; Gold, Linda Stein

BACKGROUND:

Hyperkeratotic plaque psoriasis represents a distinct morphological variant that is difficult to treat with topical therapies because thick lesions may impede the penetration of active ingredients. The immunoregulatory mechanisms of topical corticosteroids (TCSs) and tazarotene (TAZ) may contribute to combating hyperkeratosis and long-term remittance of psoriasis. A fixed-combination lotion containing the potent-to-superpotent TCS halobetasol propionate (HP, 0.01%) and TAZ (0.045%), indicated for the topical treatment of plaque psoriasis in adults, was developed to harness the therapeutic benefits of each active ingredient while minimizing their safety concerns.

METHODS:

This review describes data supporting the efficacy of halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) and remittive effect after treatment cessation in patients with hyperkeratotic plaques.

RESULTS:

Pivotal trials demonstrate the superior efficacy and safety of HP/TAZ over each active ingredient alone. Furthermore, we summarize a recent clinical study, which showed that HP/TAZ reduces lesional levels of tumor necrosis factor alpha and interleukin 17A, critical proinflammatory cytokines involved in keratinocyte hyperproliferation and psoriasis pathogenesis.

CONCLUSION:

This review suggests that HP/TAZ is a valuable option for the topical treatment of severe hyperkeratotic plaques through its additive mechanisms targeting inflammation and keratinocyte regulation.

2025-08-01·Journal of Drugs in Dermatology

Halobetasol Propionate/Tazarotene Lotion for Scalp Psoriasis: Efficacy in Itch Reduction, Disease Clearance, and Hair Appearance

Article

作者: Draelos, Zoe ; Jacobson, Abby

Scalp involvement in plaque psoriasis is accompanied by itching and scaling that reduce quality of life and exacerbate psoriatic-associated hair loss. Challenges for the topical treatment of scalp psoriasis include messy formulations that reduce patient adherence and dermal penetration in hair-bearing areas. This open-label study evaluated the efficacy of fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ, indicated for the topical treatment of plaque psoriasis in adults) in subjects with moderate-to-severe scalp psoriasis. Subjects applied HP/TAZ to the scalp once daily for 12 weeks and were evaluated at 4-week intervals. Endpoints included subject-reported scalp itch, investigator-reported psoriasis scalp severity index (PSSI), and investigator- and subject-reported hair and scalp assessments. From baseline, subjects experienced significant reductions in scalp itch and PSSI by week 12 (-49% and -93%, respectively; P≤0.001). Similarly, ratings for all investigator- and subject-assessed hair and scalp parameters were significantly improved from baseline at week 12 (P≤0.002 for all). No adverse events were reported. HP/TAZ is an efficacious treatment for scalp psoriasis, and reductions in psoriatic disease and itch may reduce scratching, leading to improvements in hair and scalp health.

2025-06-01·Journal of Drugs in Dermatology

Clinical Profile of Halobetasol Propionate 0.01%/ Tazarotene 0.045% Lotion in Patients With Hyperkeratotic Plaque Psoriasis

Article

作者: Stein Gold, Linda ; Tanghetti, Emil ; Lain, Edward ; Abby, Abby

BACKGROUND:

Hyperkeratotic psoriatic plaques, characterized by considerable elevation and scaling, present treatment challenges with topical therapy. This post hoc analysis of two phase 3 trials evaluated the efficacy and tolerability of fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ; indicated for the topical treatment of plaque psoriasis in adults) in treating hyperkeratotic plaques.

METHODS:

Participants received HP/TAZ or vehicle daily for 8 weeks, with a 4-week posttreatment follow-up. Multiple subpopulations represented patients with hyperkeratotic plaques. Analysis 1 included a subgroup with severe plaque elevation and a second subgroup with severe scaling. Analysis 2 included a subgroup with either an investigator's global assessment (IGA) of 3 with moderate-to-severe plaque elevation or an IGA of 4. Endpoints included plaque elevation and/or scaling success (greater than or equal to 2-grade improvement for either) and safety assessments.

RESULTS:

At week 8, the severe plaque elevation subgroup and severe scaling subgroup achieved plaque elevation and scaling success, respectively, at significantly greater rates with HP/TAZ versus vehicle (P<0.05 for all; Analysis 1). Analysis 2 participants achieved significantly greater rates of plaque elevation and scaling success with HP/TAZ versus vehicle at week 8 (P less than or equal to 0.001 for all). Tolerability improved from baseline by >46% for all subgroups. Adverse events were similar between treatment groups.

CONCLUSION:

HP/TAZ was efficacious and well tolerated for treating hyperkeratotic plaques.

CITATION:

Tanghetti E, Stein Gold L, Lain E, Jacobson A. Clinical profile of halobetasol propionate 0.01%/tazarotene 0.045% lotion in patients with hyperkeratotic plaque psoriasis. J Drugs Dermatol. 2025;24(6):590-598. doi:10.36849/JDD.8720R1.

项与丙酸乌倍他索相关的新闻（医药）

2026-04-08

·健康导航中

各种皮肤病的一线用药。

💊 皮肤病一线原研药外用药膏权威指南 Topical Dermatology First-Line Original Brand Drugs Guide 参考来源：AAD · EDF · NICE/BNF · PCDS · JAAD · NEJM · JAMA Dermatology ⚠️ 本文档仅供医学专业人员参考，临床用药请遵循医嘱。原研药以原厂商品标准剂型为准。 📖 关于本指南本文档依据美国皮肤科学会（AAD）、欧洲皮肤病论坛（EDF）、英国NICE/BNF、原发性皮肤病护理学会（PCDS）等国际权威指南，整理出15大类常见皮肤病的一线推荐外用原研药（品牌药）信息，包含药物通用名、原研品牌名、生产商、适应症、用法及证据级别。原研药定义：指首个获得专利并上市销售的品牌药物，含有经严格临床试验验证的活性成分与专利配方，代表该成分的最高研发标准。 📋 目录 · CONTENTS 15大皮肤病类别 · 70+原研药品一特应性皮炎（湿疹）糖皮质激素 · 钙调磷酸酶抑制剂 · PDE4抑制剂二寻常型银屑病维生素D类似物 · 糖皮质激素 · 复方制剂三寻常型痤疮维A酸类 · 过氧化苯甲酰 · 抗生素外用四玫瑰痤疮（酒渣鼻）伊维菌素 · 甲硝唑 · 壬二酸五浅表皮肤真菌感染丙烯胺类 · 唑类抗真菌药六脓疱疮（细菌性感染）莫匹罗星 · 夫西地酸 · 瑞他帕菌素七疥疮 5%氯菊酯乳膏 · 苯甲酸苄酯八单纯疱疹 / 带状疱疹阿昔洛韦 · 喷昔洛韦九白癜风他克莫司软膏 · 鲁索替尼乳膏十脂溢性皮炎酮康唑 · 环吡酮胺 · 他克莫司十一接触性皮炎强效糖皮质激素 · 他克莫司十二扁平苔藓超强效糖皮质激素 · 他克莫司十三瘢痕疙瘩 / 增生性瘢痕糖皮质激素制剂 · 硅凝胶十四银屑病甲他扎罗汀 · 卡泊三醇 · 倍他米松十五糖皮质激素效价分级参考国际标准7级分类 🔬 特应性皮炎（湿疹）Atopic Dermatitis 全球发病率15%~20% · 儿童最常见慢性皮肤病 📌 AAD 2023 & 2025 Guidelines · EDF EuroGuiDerm 2025 · JAAD 2024 特应性皮炎（AD）是以反复发作的瘙痒性湿疹为特征的慢性炎症性皮肤病，病理机制涉及Th2/Th22免疫轴失衡、皮肤屏障缺陷（Filaggrin基因突变）和微生物失调。外用药是轻中度AD的一线治疗。 ▌ 一线外用糖皮质激素（Topical Corticosteroids，TCS）通用名原研品牌生产商效价级别主要适应症 & 用法氢化可的松 1%Hydrocortisone 1% Hytone®(Dermol) Medimetriks / Dermol Ⅶ级（弱效）面部、皮肤褶皱处AD；每日2次，薄涂。婴儿首选。地奈德 0.05%Desonide 0.05% DesOwen®Desowen Galderma Ⅵ级（弱-中）面部及皮肤敏感区AD；每日2次。适合婴幼儿及长期维持。曲安奈德 0.1%Triamcinolone 0.1% Kenalog® Bristol-Myers Squibb Ⅳ级（中效）成人躯干四肢AD；每日2~3次。需限制使用时间（≤2周）。糠酸莫米松 0.1%Mometasone furoate Elocon®Elocom Organon / MSD Ⅳ级（中效）成人及2岁以上躯干四肢AD；每日1次，副作用较少，适合维持治疗。丙酸氟替卡松 0.05%Fluticasone prop. Cutivate® GlaxoSmithKline Ⅳ级（中效）成人及1岁以上儿童；每日1~2次。维持治疗有良好安全记录。卤倍他索丙酸酯 0.05%Halobetasol Ultravate® Sun Pharma Ⅱ级（超强效）成人顽固性AD、苔藓化皮损；每日1~2次，≤2周。 ▌ 钙调磷酸酶抑制剂（Topical Calcineurin Inhibitors，TCI）——免激素替代通用名原研品牌生产商效价级别主要适应症 & 用法他克莫司软膏 0.03%/0.1%Tacrolimus Protopic® Astellas Pharma FDA批准（处方） 2岁以上AD；0.03%用于儿童，0.1%用于成人。每日2次。面部/皱褶首选，无皮肤萎缩风险。吡美莫司乳膏 1%Pimecrolimus Elidel® Galderma FDA批准（处方） 2岁以上轻中度AD；每日2次。温和面部外用，适合长期间歇维持。 ▌ PDE4抑制剂 & JAK抑制剂（新型非激素外用药）通用名原研品牌生产商效价级别主要适应症 & 用法克立硼罗软膏 2%Crisaborole Eucrisa® Pfizer FDA 2016批准 ≥3个月AD；每日2次。温和非激素，适合面部及长期使用。PDE4抑制剂。鲁索替尼乳膏 1.5%Ruxolitinib Opzelura® Incyte FDA 2021批准 12岁以上轻中度AD；每日2次。JAK1/2抑制剂，起效快，证据级别最高。地尔替拉乳膏 0.5%Delgocitinib Corectim® LEO Pharma 日本/欧洲批准成人AD；每日2次。泛JAK抑制剂，在欧洲获批。 💡 AAD 2025阶梯治疗要点 ① 轻度AD → 弱效TCS（地奈德/氢化可的松）+ 高频润肤剂（Moisturizer first）② 中度AD → 中效TCS（糠酸莫米松/丙酸氟替卡松）或TCI（Protopic/Elidel）③ TCS不耐受/面部 → 首选TCI或克立硼罗（Eucrisa）④ 快速缓解需求 → 鲁索替尼（Opzelura，1~2天起效）⑤ 重度AD → 升级生物制剂（度普利尤单抗等） 🧬 寻常型银屑病 Psoriasis Vulgaris 全球发病率2%~3% · 慢性免疫介导炎症 📌 AAD/NPF 2020 Guidelines · NICE TA 2018 · EDF 2022 · PCDS 2024 银屑病是以Th17/IL-23轴过度激活、角质形成细胞异常增殖为特征的慢性炎症性皮肤病。外用治疗是轻中度（BSA<10%）的一线方案。强烈推荐维生素D类似物+糖皮质激素复方制剂。 ▌ 维生素D3类似物（Vitamin D Analogues）通用名原研品牌生产商剂型主要适应症 & 用法卡泊三醇 0.005%Calcipotriol Dovonex®Daivonex Leo Pharma 乳膏/软膏/溶液轻中度银屑病；每日2次。体部皮损首选，不可用于面部及皮肤褶皱。他卡西醇Tacalcitol Curatoderm® Maruho 软膏轻度银屑病；每日1次（睡前）。日本及欧洲广泛使用，刺激性低。钙泊三醇/倍他米松复方Calcipotriol+Betamethasone Taclonex®(美)Enstilar®(欧) Leo Pharma 软膏/泡沫剂 NICE/AAD强烈推荐一线。每日1次，可用于体部及头皮。泡沫剂（Enstilar）渗透性更佳，4周疗程。 ▌ 超强效糖皮质激素单药（Superpotent TCS）通用名原研品牌生产商剂型主要适应症 & 用法丙酸氯倍他索 0.05%Clobetasol propionate Temovate®Dermovate® GSK / Teva 乳膏/软膏/溶液/泡沫顽固性银屑病；每日2次，≤4周。头皮银屑病推荐Clobex®泡沫剂或溶液。氟轻松 0.1%Fluocinolone acetonide Synalar® ICN/Valeant 乳膏/软膏慢性稳定型银屑病；每日2~3次。头皮制剂Derma-Smoothe/FS®可长期使用。哈西奈德 0.1%Halcinonide Halog® Ranbaxy 乳膏/软膏 Ⅱ级效价，增厚皮损；每日2~3次，需间歇使用避免萎缩。 ▌ 维A酸类外用药通用名原研品牌生产商剂型主要适应症 & 用法他扎罗汀 0.045%/0.1%Tazarotene Tazorac®Fabior(泡沫) Almirall / Bausch 乳膏/凝胶/泡沫斑块型银屑病；每晚1次。需防晒，孕妇禁用。可联合TCS协同增效。 🏆 银屑病外用治疗推荐级别（NICE/AAD）【A级推荐】卡泊三醇+倍他米松复方（Taclonex®/Enstilar®）—— 疗效最优、顺应性最佳【A级推荐】单用超强效TCS（氯倍他索/哈西奈德）间歇疗法【B级推荐】他扎罗汀乳膏（联合TCS效果更优）【注意】头皮银屑病：优先选择溶液/泡沫剂型（Clobex® Spray、Enstilar® Foam） 🫧 寻常型痤疮 Acne Vulgaris 全球最常见皮肤病 · 85%青少年受累 📌 AAD 2024 Guidelines (JAAD) · NICE CKS 2024 · BCAP UK 2024 AAD 2024年痤疮指南强烈推荐：过氧化苯甲酰（BPO）、外用维A酸类和外用抗生素为三大核心外用药。所有含抗生素方案须联合BPO以降低耐药风险。 ▌ 维A酸类（Topical Retinoids）—— 痤疮治疗基石通用名原研品牌生产商浓度/剂型适应症 & 用法阿达帕林Adapalene Differin® Galderma 0.1%/0.3% 凝胶/乳膏闭口粉刺/炎症性痤疮；每晚1次。刺激性最低，FDA唯一批准的OTC维A酸外用药。维A酸（全反式）tretinoin Retin-A®Retin-A Micro® Ortho Dermatologics 0.025%~0.1% 乳膏/凝胶粉刺性及炎症性痤疮；每晚1次。皮肤刺激性较高，需缓慢起始剂量。孕妇禁用。他扎罗汀Tazarotene Tazorac® Almirall 0.045%/0.1% 乳膏/凝胶中重度痤疮；每晚1次。对结节性痤疮有效，刺激性高，需防晒。阿达帕林+BPO复方Adapalene+BPO Epiduo®Epiduo Forte® Galderma 0.1%+2.5% / 0.3%+2.5% 凝胶 AAD推荐中度痤疮首选复方。每日1次，联合抗菌+溶粉刺双重机制。 ▌ 过氧化苯甲酰（Benzoyl Peroxide，BPO）通用名原研品牌生产商浓度/剂型适应症 & 用法过氧化苯甲酰 2.5%~10%Benzoyl Peroxide Brevoxyl®PanOxyl® Stiefel（GSK）/ Chattem 2.5%/5%/10% 洗剂/乳膏/凝胶 AAD A级推荐，粉刺及炎症性痤疮；每日1~2次。可单用或与抗生素联用，无耐药性。 BPO+克林霉素复方BPO+Clindamycin BenzaClin®Duac® Sanofi / Stiefel (GSK) 5%BPO+1%Clindamycin 凝胶中度炎症性痤疮；每日2次（BenzaClin®）或每日1次（Duac®）。强烈推荐联合方案。 BPO+红霉素复方BPO+Erythromycin Benzamycin® Sanofi 5%BPO+3% Ery 凝胶中度炎症性痤疮；每日2次。注意冷藏保存。 ▌ 外用抗生素（需联合BPO，单独使用易耐药）通用名原研品牌生产商浓度/剂型适应症 & 用法克林霉素磷酸酯 1%Clindamycin phosphate Cleocin T®Clindagel® Pfizer / Galderma 1% 溶液/凝胶/洗剂炎症性痤疮；每日1~2次。须联合BPO使用。甲磺酸沙地霉素 1.5%Sarecycline Seysara®(口服)—— Almirall 外用尚无原研（外用克林霉素为常用替代）壬二酸 15%/20%Azelaic acid Finacea®Skinoren® Bayer Dermatology 15% 凝胶 / 20% 乳膏轻中度炎症性痤疮及色素沉着；每日2次。适合妊娠期使用（B类），同时改善痘印。外用氨苯砜 5%/7.5%Dapsone Aczone® Almirall 5%/7.5% 凝胶 FDA批准炎症性痤疮；每日1~2次。适合成人女性，减少炎症后色素沉着。 🌹 玫瑰痤疮（酒渣鼻）Rosacea 好发于白种人 · 面颊潮红 / 炎症性丘疹脓疱 📌 AAD 2019 Guidelines · PCDS 2024 · AAFP 2024 · NRS Treatment Algorithm 通用名原研品牌生产商剂型适应症 & 用法伊维菌素 1%Ivermectin 1% Soolantra® Galderma 乳膏 PCDS一线推荐，丘疹脓疱型玫瑰痤疮；每日1次，3个月疗程。抗蠕形螨机制。壬二酸 15%Azelaic acid 15% Finacea®Skinoren® Bayer 凝胶丘疹脓疱型；每日2次。AAD强烈推荐，可改善红斑，适合妊娠期。甲硝唑 0.75%/1%Metronidazole MetroCream®Rozex®Noritate® Galderma 0.75%乳膏/凝胶；1%乳膏经典一线药，丘疹脓疱型；每日1~2次。维持治疗首选。溴莫尼定酒石酸盐 0.33%Brimonidine tartrate Mirvaso® Galderma 凝胶面部持续红斑（ETR型）；每日1次，按需使用。α2肾上腺素受体激动剂，起效快（30min）。羟甲唑啉 1%Oxymetazoline Rhofade® Allergan/AbbVie 乳膏成人持续性面部红斑；每日1次。FDA 2017批准，收缩皮肤血管，持续约12h。磷酸伊维菌素+甲硝唑复方（院外调配） ——（调配品）复合药房凝胶重度联合治疗参考（非标准原研） 🍄 浅表皮肤真菌感染 Superficial Fungal Infections 体癣 / 足癣 / 甲癣 / 花斑癣 / 念珠菌病 📌 NICE BNF 2024 · AAFP Tinea Guidelines 2025 · Carepatron Clinical Guidelines 2024 通用名原研品牌生产商类别/浓度适应症 & 用法特比萘芬 1%Terbinafine 1% Lamisil®AT Novartis / GSK 烯丙胺类，1% 乳膏 AAFP首选；体癣/足癣/股癣；每日1~2次，疗程1~2周。杀菌作用，疗程最短。克霉唑 1%Clotrimazole 1% Canesten®Lotrimin®AF Bayer / Bayer Consumer 唑类，1% 乳膏/溶液体癣/足癣/念珠菌感染；每日2~3次，2~4周。广谱抗真菌，念珠菌感染首选。咪康唑 2%Miconazole 2% Daktarin®Monistat® Janssen / J&J 唑类，2% 乳膏/散剂念珠菌病/体股癣；每日2次。Daktarin®口腔凝胶用于口腔念珠菌病。酮康唑 2%Ketoconazole 2% Nizoral® Janssen 唑类，2% 乳膏/洗剂花斑癣/脂溢性皮炎；每日1~2次，2~4周。Nizoral洗发水（1%/2%）用于头皮。益康唑 1%Econazole 1% Spectazole®Pevaryl® Ortho/Cilag 唑类，1%乳膏体癣/足癣/念珠菌感染；每日2次，2~4周。卢立康唑 1%Luliconazole 1% Luzu® Onyx Therapeutics 唑类，1%乳膏 FDA 2013批准；趾间型足癣/体股癣；每日1次，1~2周。最新一代唑类，耐药率低。环吡酮胺 0.77%Ciclopirox Loprox®Penlac® Medicis/Sanofi 乳膏/凝胶/甲涂剂体癣/甲真菌病；乳膏每日2次；甲涂剂每周1次。广谱，兼具抗炎作用。阿莫罗芬 0.25%/5%Amorolfine Loceryl® Galderma 甲涂剂5%，乳膏0.25% 甲真菌病；甲涂剂每周1~2次（欧洲一线推荐）。乳膏用于体癣，欧洲广泛使用。 🦠 脓疱疮及细菌性皮肤感染 Impetigo & Bacterial Infections 金黄色葡萄球菌 / A群链球菌为主 📌 NICE BNF 2024 · AAFP 2014 · WHO Essential Medicines List 2023 通用名原研品牌生产商类别适应症 & 用法莫匹罗星 2%Mupirocin 2% Bactroban® GlaxoSmithKline 假单酸类抗生素 NICE/AAD一线推荐；非大疱性脓疱疮；每日3次，5天。鼻腔MRSA去定植（鼻用软膏）。夫西地酸 2%Fusidic acid 2% Fucidin® Leo Pharma 夫西地烷类抗生素脓疱疮/浅表皮肤感染；每日3次，5~7天。欧洲广泛使用，注意耐药监测。瑞他帕菌素软膏 1%Retapamulin 1% Altabax®Altargo® GSK 截短侧耳素类抗生素 FDA 2007批准；非大疱性脓疱疮；每日2次，5天。对MRSA局部有效。奥泽沙星乳膏 1%Ozenoxacin 1% Xepi® Ferrer / Maruho 喹诺酮类 FDA 2017批准；成人及≥2个月婴儿非大疱性脓疱疮；每日2次，5天。无耐药风险。 🦟 疥疮 Scabies 疥螨感染 · 夜间剧痒 · 传染性强 📌 WHO Guidelines 2020 · Queensland Health Scabies Guidelines 2024 · NICE CKS 通用名原研品牌生产商浓度用法 5%氯菊酯乳膏Permethrin 5% Elimite®Acticin® Prestium Pharma / Connetics 5% 乳膏全球一线首选；全身涂抹8~14h后洗去，7~14天后重复1次。安全用于2个月以上婴儿。 1%苯甲酸苄酯乳液Benzyl benzoate Ascabiol® Sanofi 25% 乳液（稀释至10%~12.5%用于儿童）经济替代方案，全身涂抹24h；可重复2~3次。皮肤刺激性较高。 10%/25%硫磺软膏Sulfur ointment 通用名多家厂商 10%~25% 软膏妊娠期/2个月以下婴儿安全替代；连续涂抹3天，价廉易得。 🧫 病毒性皮肤感染 Viral Skin Infections 单纯疱疹 / 带状疱疹 / 尖锐湿疣 📌 CDC STI Guidelines 2021 · AAD Herpes Guidelines · NICE CKS 2024 通用名原研品牌生产商适应症用法阿昔洛韦 5%软膏Acyclovir 5% Zovirax® GlaxoSmithKline 口唇疱疹/生殖器疱疹（辅助）每日5次（每3h），5天。外用效果有限，口服更有效，主要用于局部辅助。喷昔洛韦 1%乳膏Penciclovir 1% Denavir®Vectavir® Novartis / GSK 口唇疱疹（复发型）每2h 1次（日间），4天。FDA批准外用抗病毒药，较阿昔洛韦皮肤渗透更佳。咪喹莫特 5%/3.75%乳膏Imiquimod Aldara®Zyclara® Medicis/3M 尖锐湿疣/浅表基底细胞癌/日光性角化每周3次（5%），或每日1次（3.75%），涂8h后洗去。免疫调节剂，疗程6~16周。鬼臼毒素 0.5%溶液/0.15%乳膏Podophyllotoxin Condylox®Wartec® Prometheus / Stiefel 尖锐湿疣每日2次，连用3天，休4天，最多4个疗程。患者自用方案首选。鬼臼树脂 15%~25%溶液Podophyllin Podocon-25® Paddock Labs 尖锐湿疣（医生施用）诊室内应用，涂后1~4h洗去，每周1次。不可患者自行使用，致畸。 ⬜ 白癜风 Vitiligo 自身免疫性黑素细胞脱失 · 全球1%发病率 📌 Pigmentary Disorders Society Consensus 2024 (CCID) · NEJM 2022 · AAD Guidelines 通用名原研品牌生产商机制适应症 & 用法他克莫司软膏 0.1%Tacrolimus 0.1% Protopic® Astellas Pharma 钙调磷酸酶抑制剂非节段性白癜风一线推荐（CCID 2024）；每日2次。面部/皱褶皮损首选，可联合NB-UVB。吡美莫司乳膏 1%Pimecrolimus 1% Elidel® Galderma 钙调磷酸酶抑制剂活动期白癜风辅助；每日2次。刺激性低，适合面部，疗效略弱于他克莫司。鲁索替尼乳膏 1.5%Ruxolitinib 1.5% Opzelura® Incyte JAK1/2抑制剂 FDA 2022首个批准用于白癜风的外用药（12岁以上）；每日2次。NEJM 2022 Phase III证明有效。糠酸莫米松 0.1%Mometasone furoate Elocon® Organon 中效糖皮质激素活动期白癜风联合治疗；每日1次，间歇疗法。不可长期单药使用。 ⭐ Opzelura® 里程碑意义 Ruxolitinib（鲁索替尼）乳膏是FDA历史上首个批准外用治疗白癜风的新药。NEJM 2022年双盲随机对照试验显示：使用Opzelura® 52周后，30%以上患者面部白斑面积复色≥75%（F-VASI75），远优于安慰剂组（9%）。这是白癜风外用治疗领域的重大突破。 🧴 脂溢性皮炎 Seborrheic Dermatitis 马拉色菌相关 · 头皮/面部T区好发 📌 AAD Guidelines 2015 · PCDS 2024 · NICE CKS 2024 · Cochrane Review 2022 通用名原研品牌生产商剂型用法酮康唑 2%Ketoconazole 2% Nizoral® Janssen 洗发水/乳膏头皮脂溢：Nizoral®洗发水每周2次，4周；面部脂溢：乳膏每日1~2次，4周。一线首选。环吡酮胺 1%Ciclopirox 1% Loprox® Sanofi 洗发水/乳膏/凝胶头皮/面部脂溢；洗发水每周2~3次；凝胶每日2次。抗菌+抗炎双重作用。硫化硒 1%/2.5%Selenium sulfide Selsun®Selsun Blue® Abbott / Chattem 洗发水/洗液头皮脂溢/花斑癣；每周2次，疗程4周。2.5%需处方。他克莫司软膏 0.1%Tacrolimus 0.1% Protopic® Astellas 软膏顽固性面部脂溢（对激素/抗真菌不耐受）；每日2次。去氢可的松+抗真菌复方Desonide+Antifungal Clobex®+Nizoral® 联合联合方案乳膏严重脂溢性皮炎急性期：短期TCS联合抗真菌（2~4周），后维持抗真菌单药。 🧤 接触性皮炎 Contact Dermatitis 刺激性接触性皮炎（ICD）/ 变应性接触性皮炎（ACD） 📌 AAD Guidelines · NICE CKS 2024 · EAACI Contact Dermatitis Guidelines 通用名原研品牌生产商效价适应症 & 用法丙酸氟替卡松 0.05%Fluticasone prop. Cutivate® GSK Ⅳ级中效急性接触性皮炎（中度）；每日1~2次，最多2周。氯倍他索 0.05%Clobetasol prop. Temovate®Dermovate® GSK Ⅱ级超强效严重过敏性接触性皮炎；每日2次，≤2周。顽固皮损首选。他克莫司 0.1%Tacrolimus Protopic® Astellas 非激素慢性接触性皮炎面部皮损；每日2次。避免激素萎缩风险。氧化锌软膏Zinc oxide paste Desitin®Sudocrem® J&J / Forest Labs 屏障保护剂急性期局部保护；不限制，持续涂抹。作为基础屏障修复。 🍃 扁平苔藓 Lichen Planus 自身免疫性T淋巴细胞攻击基底层角质形成细胞 📌 JAMA Dermatology 2025 · UpToDate 2024 · Cochrane Review 通用名原研品牌生产商类型用法氯倍他索 0.05%Clobetasol prop. Temovate®Dermovate® GSK 超强效TCS 皮肤型扁平苔藓一线；每日2次，4~8周，间歇使用。肥厚型可闭塞疗法增效。他克莫司软膏 0.1%Tacrolimus 0.1% Protopic® Astellas 钙调磷酸酶抑制剂口腔/外阴扁平苔藓一线（黏膜型首选）；每日2次。曲安奈德口腔糊剂 0.1%Triamcinolone acetonide Kenalog in Orabase® Bristol-Myers Squibb 中效TCS糊剂口腔扁平苔藓经典用药；每日2~3次涂于患处，不可漱口。丙酸氟替卡松吸入剂（漱口）Fluticasone propionate inhaler Flonase®/Cutivate® GSK 超说明书使用口腔扁平苔藓（漱口液方案）；每日2~4次，不吞咽。Cochrane证据支持。 ⚡ 瘢痕疙瘩 / 增生性瘢痕 Keloids & Hypertrophic Scars 纤维母细胞异常增殖 · 胶原过度沉积 📌 UpToDate 2024 · ISSS Guidelines · Dermatology Reviews 2023 通用名原研品牌生产商剂型用法氟轻松0.025%+醋酸+丙二醇Fluocinolone acetonide tape Cordran®Tape Lannett 含药胶带增生性瘢痕；贴敷12h/天，2~3个月。闭塞疗法增强TCS渗透，ISSS A级推荐。硅凝胶片/凝胶Silicone gel sheet Mepiform®ScarSil®Kelo-cote® Mölnlycke / Alliance / Crawford 贴片/凝胶增生性瘢痕/预防瘢痕；贴敷≥12h/天，3~6个月。一线非药物治疗，证据充分。洋葱提取物+肝素+尿囊素Onion extract gel Contractubex® Merz Pharmaceuticals 凝胶增生性/成熟瘢痕；每日3次按摩涂抹，≥3个月。欧洲广泛使用，辅助软化。肾上腺素纱布（诊室内局注）Triamcinolone 40mg/mL Kenalog® BMS 注射剂（局部注射）瘢痕疙瘩一线（局注，非外涂）；每4~6周1次，总3~6次。外用单独效果有限。 💅 银屑病甲 Nail Psoriasis 指甲点状凹陷 / 甲板增厚 / 油斑征 📌 GRAPPA Guidelines 2021 · NICE 2022 · AAD Nail Psoriasis Guidelines 2023 通用名原研品牌生产商剂型用法他扎罗汀 0.1%Tazarotene 0.1% Tazorac® Almirall 凝胶轻中度银屑病甲一线；每晚1次涂甲板及周围，封包。适合甲板受累。卡泊三醇/倍他米松复方Calcipotriol+Betamethasone Taclonex®Enstilar® Leo Pharma 软膏/泡沫甲周银屑病；每日1次，4~8周。甲周及甲床受累首选。 5-氟尿嘧啶乳膏 1%/5%5-Fluorouracil Efudex®Carac® Valeant/Dermik 乳膏（超说明书）难治性银屑病甲（甲板增厚）；每日2次封包，部分研究证据支持。氯倍他索溶液 0.05%Clobetasol solution Clobex® Galderma 溶液甲周及甲板银屑病；每晚1次，4周。高渗透溶液剂型更易渗入甲板。 📊 外用糖皮质激素（TCS）国际效价分级参考表 WHO / FDA 七级分类标准 📌 WHO Model List · FDA TCS Classification · Cornell Classification System 外用糖皮质激素按血管收缩试验（Ⅰ~Ⅶ级，Ⅰ级最强）或按效价（超强效/强效/中效/弱效）分类。选择时须根据皮损严重程度、部位、患者年龄及疗程综合评估。效价级别代表原研药（品牌名）通用名浓度适用部位 Ⅰ级（超强效） Diprolene® (Schering) 氯倍他索增效酯丙二醇Betamethasone dipropi. 0.05% 厚皮皮损（手掌/足底/苔藓化），≤2周 Ⅱ级（超强效） Temovate®/Dermovate® (GSK) 丙酸氯倍他索Clobetasol propionate 0.05% 成人顽固皮损，≤2周，避免面部 Ⅱ级（超强效） Ultravate® (Sun Pharma) 卤倍他索Halobetasol prop. 0.05% 厚皮损，≤2周 Ⅲ级（强效） Lidex® (Medicis) 氟轻松醋酸酯Fluocinolide 0.05% 非面部皮损，4周内 Ⅳ级（中强效） Elocon® (Organon/MSD) 糠酸莫米松Mometasone furoate 0.1% 成人体部，每日1次，可较长期使用 Ⅳ级（中强效） Cutivate® (GSK) 丙酸氟替卡松Fluticasone prop. 0.005%/0.05% 成人及儿童（≥1岁）体部 Ⅴ级（中效） Westcort® (Westwood) 戊酸氢化可的松Hydrocortisone valerate 0.2% 面部（短期）/一般皮损 Ⅵ级（弱中效） DesOwen® (Galderma) 地奈德Desonide 0.05% 面部/皱褶/儿童，可较长期使用 Ⅶ级（弱效） Hytone® (Medimetriks) 氢化可的松Hydrocortisone 0.5%/1%/2.5% 面部/眼睑/皱褶/婴儿，长期可用用药重要注意事项 & 药物安全警示 ⚠️ 🚫 妊娠用药 A类（最安全）→ B类 → C类 → D类 → X类（禁用）妊娠期安全：氧化锌、硫磺软膏（A/B）；壬二酸（B）；弱效TCS（B）。禁用：维A酸类（X）、他扎罗汀（X）、氟尿嘧啶（X）、鬼臼毒素（X）。 👶 儿童用药面部/皱褶：优先弱效TCS（Ⅵ~Ⅶ级）或TCI（他克莫司0.03%/吡美莫司）。严格限制超强效TCS使用于儿童（<12岁原则上不用Ⅰ~Ⅱ级）。克立硼罗（Eucrisa）适合≥3个月婴儿，安全性好。 ⏱️ TCS使用原则间歇疗法（每周2次维持）优于连续长期使用，降低皮肤萎缩/毛细血管扩张风险。手掌/足底可耐受较长期强效TCS；面部/阴囊仅用弱效，疗程≤2周。大面积使用强效TCS需警惕HPA轴抑制（成人>50g/周，儿童更低）。 💊 抗生素耐药外用抗生素（克林霉素、红霉素）单药使用易诱导痤疮丙酸杆菌耐药。AAD 2024强制推荐：所有外用抗生素方案须联合过氧化苯甲酰（BPO）使用。外用夫西地酸不宜长期单药用于脓疱疮，建议疗程≤7天。 🔬 原研药 vs 仿制药仿制药（Generic）含相同活性成分，但赋形剂（基质）可能不同，影响皮肤渗透、刺激性和疗效。维A酸类（Retin-A Micro微球缓释技术）、TCI（Protopic软膏基质专利）等原研剂型在透皮性上具优势。临床研究通常基于原研药数据，效价分级也以原研品牌为标准。 📚 参考文献 References 1. Drucker AM, et al. "2025 focused update of the AAD guidelines for atopic dermatitis." JAAD, 2025. https://doi.org/10.1016/j.jaad.2025.02.125 2. EuroGuiDerm Guideline on Atopic Eczema (Living Guideline, March 2025). European Dermatology Forum. https://guidelines.edf.one/guidelines/atopic-ezcema 3. Armstrong AW, et al. "Guidelines of care for the management of psoriasis with topical therapy." JAAD, 2021;84(2):432-470. 4. Zaenglein AL, et al. "Guidelines of care for the management of acne vulgaris." JAAD, 2024;90(5):1006.e1-1006.e30. https://doi.org/10.1016/j.jaad.2023.12.048 5. Thiboutot DM, et al. "New insights into the management of acne." JAAD, 2023. AAD Updated Acne Guidelines. 6. Tanghetti E, et al. "First-line acne treatment: efficacy and safety review." Journal for Nurse Practitioners, 2023;19(5). 7. PCDS. "Rosacea Clinical Guidance." Primary Care Dermatology Society, 2024. https://www.pcds.org.uk/clinical-guidance/rosacea 8. Kerob D, et al. "Rosacea: Practical Guidance." PMC, 2024. PMC10821660. Dermatology and Therapy. 9. NICE BNF. "Skin infections — treatment summaries." British National Formulary, 2024. https://bnf.nice.org.uk/treatment-summaries/skin-infections/ 10. Carepatron. "Tinea Infection Treatment Guidelines." Clinical Resource, August 2024. 11. Queensland Health. "Scabies Public Health Management Guideline." 2024. 12. Sarkar R, et al. "Topical Tacrolimus in Vitiligo: Consensus Paper from the Pigmentary Disorders Society." Clinical, Cosmetic and Investigational Dermatology, December 2024. doi:10.2147/CCID.S455602 13. Rosmarin D, et al. "Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo." New England Journal of Medicine, 2022;387:1445-1455. doi:10.1056/NEJMoa2118828 14. JAMA Dermatology. "Hypertrophic Lichen Planus." 2025. doi:10.1001/jamadermatol.2025.2089 15. GRAPPA. "Group for Research and Assessment of Psoriasis and Psoriatic Arthritis Guidelines for Nail Psoriasis." 2021. 16. 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2026-03-06

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2026年银屑病头皮治疗药物：开启全新治疗篇章

银屑病是一种慢性、复发性、炎症性皮肤病，约有80%的患者会伴有头皮受累。头皮银屑病不仅表现为鳞屑和瘙痒，严重时还可能影响发际线、前额及颈后，给患者的日常生活和心理带来双重负担。随着医学研究的深入，2026年的治疗策略更加注重精准化与个体化，特别是针对头皮这一特殊部位的治疗迎来了诸多突破。以下是针对银屑病头皮治疗的不同类别药物解析，涵盖了生物制剂、外用药物及口服靶向药物，帮助患者更全面地了解当前的治疗选择。一、生物制剂：精准靶向，强效清除生物制剂通过阻断银屑病发病过程中的关键炎症因子，实现皮损的显著改善。对于中重度或对传统治疗应答不佳的头皮银屑病患者，生物制剂提供了新的选择。目前国内批准的生物制剂适应证主要为中重度寻常型银屑病，对于头皮、生殖器等特殊部位受累的患者，在医生评估后也可尝试使用。生物制剂主要分为TNF-α抑制剂和以白介素为靶点的二代生物制剂，后者对结核和乙肝病毒激活的风险较低，已成为临床主要治疗药物。1. 匹康奇拜单抗主要特点：作为一种靶向IL-23p19亚基的生物制剂，匹康奇拜单抗在临床试验中针对难治部位展现了突出的疗效。其给药方案为前三次（第0、4、8周）每次200mg进行诱导治疗，之后进入每12周一次100mg的维持期，这种长间隔的给药模式有助于慢病管理。效果如何：在针对头皮银屑病的分析中，治疗第16周时，达到头皮皮损完全清除（PSSI 100）的患者比例接近八成。至第52周，头皮特异性评分较基线改善超过97%。对于生殖器部位这一特殊受累区域，第16周时达到皮损清除或几乎清除（sPGA-G 0/1）的应答率高达91.5%。注意事项：在临床试验周期内，其整体不良事件发生率与安慰剂组相当（66.6% vs 65.7%），因不良事件导致的停药率较低。用药前需进行结核筛查，并在医生指导下定期随访。2. 古塞奇尤单抗主要特点：同样属于IL-23抑制剂，通过阻断IL-23信号通路发挥作用。维持期通常为每8周给药一次。效果如何：临床数据显示，在治疗头皮银屑病方面，第16周时达到PSSI 90和PSSI 100的应答率分别为65.8%和59.2%。对于超重或肥胖人群，部分真实世界研究提示高BMI可能对疗效应答产生一定影响。注意事项：作为一种蛋白抗体类药物，需通过注射给药。治疗期间需关注潜在感染风险。3. 司库奇尤单抗主要特点：这是一种靶向IL-17A的生物制剂，属于第二代生物制剂，起效迅速，对头皮、指甲等特殊部位有较好疗效。效果如何：临床研究显示，司库奇尤单抗治疗银屑病起效较快，通常在治疗1个月后即可观察到明显疗效，皮损消退比例可达90%以上。对于头皮银屑病，多项真实世界研究证实其能快速改善头皮鳞屑和瘙痒症状。注意事项：需注意IL-17抑制剂类药物在患有炎性肠病的患者中需谨慎使用。注射部位可能出现红斑、瘙痒等局部反应，通常轻微且可自行缓解。二、外用药物：基础治疗，一线选择对于轻中度头皮银屑病，或作为生物制剂的辅助治疗，外用药物仍是基础且重要的手段。外用糖皮质激素是银屑病的一线基础治疗选择。1. 糖皮质激素与维生素D3衍生物的复方制剂主要特点：这是目前治疗头皮银屑病的一线选择之一。通常以搽剂、凝胶或泡沫剂型存在，便于在头皮部位涂抹。复方制剂兼顾了激素的快速抗炎作用和维生素D3衍生物调节细胞分化的功能。效果如何：在初始治疗阶段，这种复方制剂能快速控制鳞屑和瘙痒。在维持期，每周使用1-2次有助于延缓复发。注意事项：长期连续使用单一激素可能导致皮肤萎缩或毛细血管扩张。选择合适的剂型（如搽剂比软膏更适合头皮）对于提高患者依从性非常重要。2. 卤倍他索丙酸酯/他扎罗汀复方洗剂主要特点：这是一种固定组合的复方洗剂，含有0.01%卤倍他索丙酸酯（强效糖皮质激素）和0.045%他扎罗汀（维A酸类药物），专为头皮银屑病设计，每日使用一次。效果如何：一项开放标签研究显示，在中重度头皮银屑病患者中，每日使用该复方洗剂治疗12周后，头皮银屑病严重程度指数（PSSI）较基线改善93%，患者自我报告的头皮瘙痒评分改善49%，所有毛发和头皮健康评估指标均显著改善。注意事项：研究期间未报告不良事件，耐受性良好。维A酸类药物可能引起局部刺激，建议在医生指导下使用，避免接触眼睛。3. 罗氟司特泡沫剂主要特点：这是一种0.3%罗氟司特泡沫剂，属于磷酸二酯酶-4（PDE-4）抑制剂，通过调节炎症反应发挥作用。每日使用一次，适用于12岁及以上患者的头皮和身体银屑病。效果如何：在名为ARRECTOR的III期随机临床试验中，432例头皮和身体银屑病患者随机接受罗氟司特泡沫剂或安慰剂治疗。第8周时，66.4%的罗氟司特组患者达到头皮皮损清除或几乎清除（S-IGA成功），显著高于安慰剂组的27.8%。早在首次用药后24小时，罗氟司特组患者的头皮瘙痒即有显著改善。注意事项：研究显示两组不良事件发生率均较低，耐受性良好。可作为头皮和身体银屑病的单一疗法使用。三、口服靶向药物：便捷高效，新兴力量近年来，口服小分子靶向药物因其给药便捷和疗效确切，成为银屑病治疗领域的热点。2026年德国S3指南已明确将新型靶向小分子药物与生物制剂并列为一线治疗选择。1. 氘可来昔替尼主要特点：这是一种口服TYK2抑制剂，属于口服小分子靶向药物。TYK2抑制剂在后期临床试验中表现出优越的PASI应答率、起效迅速和良好的长期安全性。2026年德国S3指南已将其纳入并附有具体使用建议。效果如何：临床研究显示，口服TYK2抑制剂能为银屑病患者提供媲美生物制剂的疗效，且以口服方式给药，患者接受度高。注意事项：作为较新的口服靶向药物，其长期安全性数据仍在持续积累中。需在医生指导下定期监测。2. 比美吉珠单抗主要特点：这是一种新型IL-17A和IL-17F双靶点抑制剂，可同时中和IL-17A和IL-17F两种细胞因子。2026年德国S3指南已将其纳入并附有具体使用建议。效果如何：指南引用的网络荟萃分析结果显示其在银屑病治疗中具有优越的疗效。注意事项：作为生物制剂，需注射给药。其安全性特征与其他IL-17抑制剂类似。3. DC-806 主要特点：这是一种口服小分子IL-17抑制剂，通过口服方式实现类似于司库奇尤单抗等IL-17生物制剂的治疗作用。效果如何：在一项针对轻中度银屑病患者的I期临床试验中，接受DC-806 800mg每日两次治疗28天后，患者的PASI评分较基线平均降低43.7%，显著优于安慰剂组的13.3%。研究期间未发生严重不良事件或治疗相关不良事件导致的停药。注意事项：目前处于早期临床开发阶段，需要更大规模研究验证其长期疗效和安全性。不同类型银屑病的治疗注意事项与日常建议银屑病根据临床表现可分为寻常型（斑块状）、关节病型、红皮病型等，其中头皮银屑病多为寻常型的一种特殊部位表现。治疗难点：头皮部位毛发覆盖，使得涂抹药膏不便，且容易因搔抓导致破损。生殖器部位皮肤薄嫩，对药物的刺激性要求更高。日常护理建议：温和洗护：选择温和、无刺激的洗发水，洗头时水温不宜过高，避免用力抓挠头皮。饮食管理：越来越多的证据表明，健康饮食模式有助于改善病情。地中海饮食（富含水果、蔬菜、全谷物和健康脂肪）与较低的银屑病严重程度相关。对于超重或肥胖患者，低热量饮食带来的体重减轻有助于改善病情。规避诱因：注意避免感冒、扁桃体炎等感染诱发因素；保持情绪稳定，避免过度紧张；限制饮酒。总结：头皮银屑病治疗药物一览对于头皮银屑病的治疗，2026年的选择更为丰富。从精准的生物制剂到便捷的口服靶向药，再到不断优化的外用方案，患者可与医生充分沟通，综合考虑病情、经济条件和用药偏好，制定最适合自己的个体化治疗方案。返回搜狐，查看更多

临床结果临床研究

2025-08-21

·ir.bauschhealth.com

Bausch Health, Canada Inc. treatment for acne vulgaris, PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide gel), now available through public drug plans of Quebec and Saskatchewan

Bausch Health, Canada Inc. treatment for acne vulgaris, PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide gel), now available through public drug plans of Quebec and Saskatchewan (English) LAVAL, QC, August 21, 2025 – Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global, diversified pharmaceutical company, today announced that PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) gel 1.2% w/w, 0.15% w/w and 3.1% w/w, for the treatment of acne vulgaris,1 is now available to beneficiaries of the public drug plans of Quebec and Saskatchewan. This new public drug plan availability of CABTREO is in addition to that announced last month for those using the Ontario and Nova Scotia public drug plans as well as through the federal government’s Non-Insured Health Benefits (NIHB) drug plan for Indigenous populations as well as those of the Correctional Service of Canada (CSC) and Veterans Affairs Canada. CABTREO is a new Canadian-made triple-combination topical prescription treatment for acne vulgaris in patients 12 years of age and older. CABTREO is the first and only triple-combination topical treatment for acne approved by Health Canada with three mechanisms of action – an antibiotic, a retinoid and an antibacterial agent – to provide a safe and effective treatment.1 “The addition of CABTREO to the Quebec and Saskatchewan public drug plans means more Canadians now have access to this innovative acne treatment – joining those already covered under most private insurance plans,” said Amy Cairns, General Manager, Bausch Health Canada. “Acne can have a significant impact on those living with it, and there is strong demand for new treatment options, increasing the importance of public drug plan coverage.” CABTREO, a prescription product, is a topical gel that is administered once daily to affected areas of the skin. Its active ingredients are the antibiotic clindamycin phosphate, the topical retinoid adapalene and the oxidizing agent benzoyl peroxide with a broad-spectrum bactericidal activity.1 About Acne Vulgaris Acne vulgaris ("vulgaris" means "common") is the most common skin problem seen by doctors in Canada. It occurs when the pores of the skin become plugged with oil and skin cells, often causing whiteheads, blackheads, pimples or cysts to appear on the face, forehead, chest, upper back and shoulders. Acne affects about 5.6 million Canadians, or nearly 20 per cent of the population, including about 90 per cent of adolescents. About 25 per cent of teens will still have acne at age 25. Acne causes emotional distress and can cause permanent scarring.2 It can also cause skin pigmentation changes.3 CABTREO Clinical Data and Safety Information CABTREO was studied in two phase 3 multicentre, randomized, placebo controlled clinical trials in 363 patients with facial acne vulgaris. Both studies met all co-primary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count, and percentage of patients achieving pre-defined treatment success. Combined efficacy results for both trials for CABTREO achieved approximately 50% treatment success and a greater than 70% reduction in both inflammatory and noninflammatory lesions at Week 12.1 The most frequent adverse reactions that may occur with CABTREO are mild to moderate application site reactions, such as skin irritation characterized by scaling, dryness, erythema, and burning/stinging. CABTREO should not be used by those who are hypersensitive to any of the ingredients in it (clindamycin phosphate, adapalene, benzoyl peroxide or to any ingredient in the formulation), patients with a history of regional enteritis (Crohn’s disease), ulcerative colitis or antibiotic-associated colitis or by pregnant women and women planning a pregnancy. CABTREO may bleach hair and coloured fabric so caution should be used when applying it near the hairline.1 Health Canada has not authorized CABTREO for pediatric use under the age of 12 years. CABTREO is for topical use only and is not for oral, ophthalmic or intravaginal use.1 About Dermatology at Bausch Health, Canada Inc. Bausch Health, Canada Inc. has one of the largest prescription dermatology businesses in Canada dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Bausch Health, Canada Inc. dermatology portfolio includes several leading acne, psoriasis, anti-fungal and corticosteroid-responsive dermatoses products. CABTREO is the fourth new dermatology treatment from Bausch Health, Canada Inc. approved by Health Canada and made available to Canadians over the past four years, adding to the company's leading portfolio in this important treatment area. The other approvals were for ARAZLOTM (tazarotene lotion, 0.045% w/w), for the topical treatment of acne vulgaris in patients 10 years of age and older; BRYHALI™ (halobetasol propionate lotion 0.01% w/w), for corticosteroid-responsive dermatoses and the topical treatment of plaque psoriasis in adults; and DUOBRII™ (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene) to treat adults with moderate to severe plaque psoriasis.4 All four treatments – CABTREO, ARAZLO, BRYHALI and DUOBRII – are manufactured at Bausch Health's Laval, Quebec, facility for Canada and the United States. About Bausch Health Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn. The Bausch Health Canadian 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. Forward-looking Statements This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, 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 and quarterly reports 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. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law. REFERENCES 1 Bausch Health, Canada Inc., CABTREO Product Monograph,https://pdf.hres.ca/dpd_pm/00076715.PDF. 2 Canadian Dermatology Association, Acne, Quick Facts,https://dermatology.ca/public-patients/skin/acne/#:~:text=Acne%20affects%205.6%20million%20Canadians,adults%20ages%2020%20to%2040, accessed Aug. 20, 2024. 3 "What to Know about Hyperpigmentation Acne." Medical News Today, Jessica Caporuscio, April 28, 2021, https://www.medicalnewstoday.com/articles/hyperpigmentation-acne, accessed Aug. 20, 2024. 4 Bausch Health, Canada Inc., Canadian Product List, https://bauschhealth.ca/products/canadian-product-list/.

临床结果临床3期上市批准

100 项与丙酸乌倍他索相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04409	丙酸乌倍他索	D07AC21	DB00596

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
斑块状银屑病	美国	Lacerta Therapeutics, Inc.	2015-11-06
皮肤疾病	美国	Sun Pharmaceutical Industries, Inc.	1990-12-17

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
中度特应性皮炎	临床2期	美国	Sun Pharmaceutical Industries Ltd.	2017-07-24
重度特应性皮炎	临床2期	美国	Sun Pharmaceutical Industries Ltd.	2017-07-24

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临床结果

适应症

分期

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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


AAD2024	临床3期	斑块状银屑病	375	Halobetasol Propionate 0.01% and Tazarotene 0.045% Lotion	膚膚醖積夢襯顧鑰壓壓(鬱繭餘鹹襯艱餘壓壓廠): P-Value = ≤0.003 更多	积极	2024-03-08
				Vehicle Lotion
NCT03992261 (CTgov)	临床4期	斑块状银屑病	24	Halobetasol Topical Foam	糧蓋糧憲獵窪繭顧襯襯 = 齋遞齋壓網憲鑰鏇廠築鑰製鹽觸齋獵糧窪繭鹽 (襯鹽繭夢鏇繭糧網顧衊, 積築築廠觸衊網鬱窪遞 ~ 網製壓襯獵衊衊蓋網艱) 更多	-	2023-07-06
NCT03212963 (CTgov)	临床4期	斑块状银屑病	16	Halobetasol Topical Lotion	糧範醖廠襯積餘壓網襯 = 網膚鏇製蓋範淵簾醖繭襯積憲構鬱簾衊製廠製 (繭淵艱鹹鏇壓獵膚膚艱, 糧鑰蓋衊餘願襯夢鏇鑰 ~ 餘遞鹽齋淵製選鑰鹽選) 更多	-	2021-12-07
NCT02785185 (CTgov)	临床2期	斑块状银屑病	150	IDP-122 Lotion (IDP-122 Lotion)	選餘鏇獵製餘壓壓膚襯 = 蓋廠鹹窪餘襯鬱繭願壓遞製艱選糧窪繭網積壓 (鑰願簾膚網簾繭醖製糧, 膚簾憲鬱衊選鏇遞廠淵 ~ 鏇願窪憲鏇壓襯鬱鹹膚) 更多	-	2020-08-27
				Ultravate Cream (Ultravate Cream)	選餘鏇獵製餘壓壓膚襯 = 糧願構鑰製廠積製夢願遞製艱選糧窪繭網積壓 (鑰願簾膚網簾繭醖製糧, 衊夢壓窪膚築窪構蓋積 ~ 餘鹽網窪繭鹹鬱窪廠艱) 更多
NCT02514577 (CTgov)	临床3期	斑块状银屑病	217	IDP-122 Lotion (IDP-122 Lotion)	願範廠獵觸觸獵築繭夢 = 醖鬱壓衊襯憲觸齋齋淵齋齋積鏇窪齋繭繭獵顧 (鑰構簾衊憲構鹽齋遞憲, 鹹餘網鬱顧選願遞簾夢 ~ 簾淵積衊遞積範觸鹽範) 更多	-	2020-01-27
				IDP-122 (IDP-122 Vehicle Lotion)	願範廠獵觸觸獵築繭夢 = 壓鏇糧餘簾膚衊網網憲齋齋積鏇窪齋繭繭獵顧 (鑰構簾衊憲構鹽齋遞憲, 選襯製夢網鬱鏇構憲顧 ~ 網廠餘壓範醖憲築廠餘) 更多
NCT02515097 (CTgov)	临床3期	斑块状银屑病	213	IDP-122 Lotion (IDP-122 Lotion)	獵鹹齋獵顧鑰淵鹽遞夢 = 醖製鬱網夢顧衊夢顧簾糧選鹹艱衊膚襯網鏇築 (夢積願壓構齋鹽窪夢範, 鑰鑰襯範鬱選餘繭艱鹽 ~ 簾憲鏇範壓壓鏇艱願獵) 更多	-	2020-01-27
				IDP-122 (IDP-122 Vehicle Lotion)	獵鹹齋獵顧鑰淵鹽遞夢 = 築鏇鏇選糧艱繭遞鑰築糧選鹹艱衊膚襯網鏇築 (夢積願壓構齋鹽窪夢範, 蓋製顧鹽壓獵窪窪襯蓋 ~ 製壓遞衊餘鏇觸壓願鏇) 更多
NCT02785185 (Pubmed \| J Dermatolog Treat)	临床2期	斑块状银屑病	150	Halobetasol propionate 0.01% lotion	選願顧廠簾鹹網醖積鏇(餘構選餘膚願觸淵衊築) = 壓製積齋鏇衊遞鏇艱醖襯窪鑰艱構顧襯簾夢構 (襯廠襯鏇製獵範願膚夢 ) 更多	-	2019-06-01
				Halobetasol propionate 0.05% cream	選願顧廠簾鹹網醖積鏇(餘構選餘膚願觸淵衊築) = 顧憲願鏇製顧遞衊糧壓襯窪鑰艱構顧襯簾夢構 (襯廠襯鏇製獵範願膚夢 ) 更多
NCT02368210 (CTgov)	临床3期	斑块状银屑病	151	122-0551 Foam (122-0551 Foam)	艱獵鬱膚夢艱糧觸簾願 = 艱鬱選糧廠糧憲鹹衊醖壓顧窪襯願壓糧膚製鹹 (鑰構積淵壓獵餘鏇醖製, 艱繭廠夢衊築壓鏇膚製 ~ 襯構餘鏇窪鹹醖築鬱鑰) 更多	-	2018-11-26
				Vehicle Foam (Vehicle Foam)	艱獵鬱膚夢艱糧觸簾願 = 齋糧壓鑰鹽積衊鬱夢選壓顧窪襯願壓糧膚製鹹 (鑰構積淵壓獵餘鏇醖製, 艱構艱簾鏇觸簾積觸窪 ~ 顧積範窪簾積糧膚遞製) 更多
NCT02742441 (CTgov)	临床3期	斑块状银屑病	409	122-0551 Foam (122-0551 Foam)	憲蓋網構製顧網鏇糧遞 = 襯繭鑰觸壓鹽廠齋蓋獵壓簾衊鹽艱壓顧齋構範 (糧觸鹹齋範膚艱膚鹹繭, 鏇顧構糧積築顧醖蓋艱 ~ 網鹽築壓齋齋構鏇壓壓) 更多	-	2018-11-14
				Vehicle Foam (Vehicle Foam)	憲蓋網構製顧網鏇糧遞 = 簾選構夢醖糧鏇選夢鑰壓簾衊鹽艱壓顧齋構範 (糧觸鹹齋範膚艱膚鹹繭, 繭壓鬱襯遞築積顧襯襯 ~ 願製製衊繭廠齋簾齋廠) 更多
NCT02515097 (Pubmed) 人工标引	临床3期	斑块状银屑病	430	Halobetasol Propionate (Study 1)	構鹽網鏇餘膚製鬱構齋(夢鏇範夢壓醖蓋窪構鹹) = 鑰範膚醖憲窪鬱壓鑰鬱窪構壓遞積鏇淵窪鹹廠 (鬱襯鏇鏇壓窪憲觸艱壓 )	积极	2018-10-01
				Halobetasol Propionate (Study 2)	構鹽網鏇餘膚製鬱構齋(夢鏇範夢壓醖蓋窪構鹹) = 艱窪選衊淵觸齋範遞憲窪構壓遞積鏇淵窪鹹廠 (鬱襯鏇鏇壓窪憲觸艱壓 )