This is a study that is being conducted in order to assess the efficacy of microneedling as a stand-alone treatment for vitiligo. Vitiligo is an autoimmune depigmentation disease of the skin that is characterized by the destruction of epidermal melanocytes by CD8+ T cells. The pathogenesis of Vitiligo has been linked to autoimmunity, oxidative stress, and genetic susceptibility.

开始日期2021-07-29

申办/合作机构

Crown Laboratories, Inc.

NCT05071274 / CompletedN/A

A Proof of Concept Study to Evaluate the Efficacy and Tolerability of Microneedling With SkinPen in Female and Male Subjects With Facial Acne Vulgaris, Ages 18 Through 45

This single-center, proof of concept trial is being conducted over the course of 42 days followed by a 2-month post-last treatment visit in order to assess the efficacy and tolerability of the Sponsor's SkinPen device in treating Acne Vulgaris on the face.

开始日期2021-03-15

申办/合作机构

Crown Laboratories, Inc.

NCT05030051 / CompletedN/A

A Proof of Concept Study to Evaluate the Efficacy and Tolerability of Skinpen on Male and Female Subjects' Dorsal Hands as a Treatment of Hand Aging

This proof of concept study is being conducted over the course of 60 days followed by a 3-month post-treatment visit to assess the efficacy and tolerability of the Sponsor's SkinPen device when used to treat men and women with signs of aging on the dorsum of the hands. Overall assessment of clinical outcome and safety will be based on the evaluation of pre-and post-treatment photos comparing baseline to final visit. The subject's assessment of satisfaction will also be evaluated at Visit 3 and Visit 4. Finally, both the clinician's and subject's assessments will be characterized using a clinician assessment scale at the 3-month post-treatment visit.

开始日期2021-03-12

申办/合作机构

Crown Laboratories, Inc.

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项与 Crown Laboratories, Inc. 相关的文献（医药）

2021-10-15·Aesthetic surgery journal2区 · 医学

A Single-Center Trial to Evaluate the Efficacy and Tolerability of Four Microneedling Treatments on Fine Lines and Wrinkles of Facial and Neck Skin in Subjects With Fitzpatrick Skin Types I-IV: An Objective Assessment Using Noninvasive Devices and 0.33-mm Microbiopsies

2区 · 医学

Article

作者: Akgul, Yucel ; Wamsley, Christine E ; Hitchcock, Thomas ; Kislevitz, Mikaela ; Barillas, Jennifer ; Kenkel, Jeffrey ; Basci, Deniz ; Kandagatla, Vishal

Abstract:

Background:

Although ablative techniques are the standard of care for the treatment of fine lines and wrinkles, microneedling offers a minimally invasive alternative.

Objectives:

The purpose of this study was to assess the efficacy of microneedling on facial and neck fine lines and wrinkles.

Methods:

Thirty-five subjects between 44 and 65 years old with Fitzpatrick skin types I to IV received 4 monthly microneedling treatments over the face and neck. Subjects returned 1 and 3 months posttreatment. At every visit, high-resolution ultrasonography and optical coherence tomography were performed, and transepidermal water loss and skin elasticity were measured. Microbiopsies (0.33 mm) were collected pretreatment, before the fourth treatment and 3 months posttreatment.

Results:

Thirty-two subjects (30 females, 2 males) completed all 7 visits. Facial dermal and epidermal density increased 101.86% and 19.28%, respectively, from baseline at 3 months posttreatment. Facial elasticity increased 28.2% from baseline at 3 months posttreatment. Facial attenuation coefficient increased 15.65% and 17.33% at 1 and 3 months posttreatment, respectively. At study completion, blood flow at a depth of 300 µm decreased 25.8% in the face and 42.3% in the neck. Relative collagen type III and elastin gene expression was statistically higher 3 months posttreatment. However, total elastin protein levels were unchanged from baseline values. Dermal muscle formation was observed in 58% of biopsies extracted 3 months posttreatment compared with 15.3% at baseline.

Conclusions:

The results illustrate the effects of microneedling treatments. Noninvasive measurements and biopsy data showed changes in skin architecture and collagen/elastin gene expression, suggesting skin rejuvenation, with new extracellular matrix production and muscle formation.

Level of Evidence: 3:

2017-02-01·Applied microbiology and biotechnology3区 · 工程技术

GH115 α-glucuronidase and GH11 xylanase from Paenibacillus sp. JDR-2: potential roles in processing glucuronoxylans

3区 · 工程技术

Article

作者: Sawhney, Neha ; Hurlbert, Jason C ; Rice, John D ; Kim, Young Sik ; Preston, James F ; Nong, Guang ; St John, Franz J ; Rhee, Hyun Jee ; Rhee, Mun Su

Paenibacillus sp. JDR-2 (Pjdr2) has been studied as a model for development of bacterial biocatalysts for efficient processing of xylans, methylglucuronoxylan, and methylglucuronoarabinoxylan, the predominant hemicellulosic polysaccharides found in dicots and monocots, respectively. Pjdr2 produces a cell-associated GH10 endoxylanase (Xyn10A₁) that catalyzes depolymerization of xylans to xylobiose, xylotriose, and methylglucuronoxylotriose with methylglucuronate-linked α-1,2 to the nonreducing terminal xylose. A GH10/GH67 xylan utilization regulon includes genes encoding an extracellular cell-associated Xyn10A₁ endoxylanase and an intracellular GH67 α-glucuronidase active on methylglucuronoxylotriose generated by Xyn10A₁ but without activity on methylglucuronoxylotetraose generated by a GH11 endoxylanase. The sequenced genome of Pjdr2 contains three paralogous genes potentially encoding GH115 α-glucuronidases found in certain bacteria and fungi. One of these, Pjdr2_5977, shows enhanced expression during growth on xylans along with Pjdr2_4664 encoding a GH11 endoxylanase. Here, we show that Pjdr2_5977 encodes a GH115 α-glucuronidase, Agu115A, with maximal activity on the aldouronate methylglucuronoxylotetraose selectively generated by a GH11 endoxylanase Xyn11 encoded by Pjdr2_4664. Growth of Pjdr2 on this methylglucuronoxylotetraose supports a process for Xyn11-mediated extracellular depolymerization of methylglucuronoxylan and Agu115A-mediated intracellular deglycosylation as an alternative to the GH10/GH67 system previously defined in this bacterium. A recombinantly expressed enzyme encoded by the Pjdr2 agu115A gene catalyzes removal of 4-O-methylglucuronate residues α-1,2 linked to internal xylose residues in oligoxylosides generated by GH11 and GH30 xylanases and releases methylglucuronate from polymeric methylglucuronoxylan. The GH115 α-glucuronidase from Pjdr2 extends the discovery of this activity to members of the phylum Firmicutes and contributes to a novel system for bioprocessing hemicelluloses.

2016-02-01·Applied microbiology and biotechnology3区 · 工程技术

Metabolic potential of Bacillus subtilis 168 for the direct conversion of xylans to fermentation products

3区 · 工程技术

Article

作者: Rice, John D ; Sawhney, Neha ; Wei, Lusha ; Kim, Young Sik ; Preston, James F ; Rhee, Mun Su

Methylglucuronoxylans (MeGXn) and methylglucuronoarabinoxylans (MeGAXn) respectively comprise most of the hemicellulose fractions in dicots and monocots and, next to cellulose, are the major resources for the production of fuels and chemicals from lignocellulosics. With either MeGXn or MeGAXn as a substrate, Bacillus subtilis 168 accumulates acidic methylglucuronoxylotriose as a limit product following the uptake and metabolism of neutral xylooligosaccharides. Secreted GH11 endoxylanase (Xyn11A), GH30 endoxylanase (Xyn30C), and GH43 arabinoxylan arabinofuranohydrolase (Axh43) respectively encoded by the xynA, xynC, and xynD genes collectively contribute to the depolymerization of MeGAXn. Studies here demonstrate the complementary roles of these enzymes in the digestion of MeGAXn. Coordinate expression of the xynD and xynC genes defines an operon accounting for the Axh43-catalyzed release of arabinose followed by Xyn30C and Xyn11A-catalyzed depolymerization of MeGAXn. Both sources generate acetate and lactate as the principal fermentation products, with yields of 26 % acetate and 32 % lactate from MeGXn compared to 22 % acetate and 21 % lactate from MeGAXn. These studies of the GH43/GH30/GH11 system in B. subtilis 168 provide a basis for the further development of B. subtilis and related species as biocatalysts for direct conversion of hemicellulose derived from energy crops as well as agricultural and forest residues to chemical feedstocks.

项与 Crown Laboratories, Inc. 相关的新闻（医药）

2024-11-04

·生物制品圈

2024年第三季度生物制药并购交易TOP 5

根据Evaluate的数据显示，生物制药行业在第三季度完成了22起并购交易，总价值达到82亿美元。在2023Q4季度和2024Q1这两个繁忙且花费高昂的季度之后，生物制药领域的并购活动在今年第三季度急剧下降，这是连续第二个季度出现下滑。交易数量和总交易价值均环比下滑，而该季度最大的交易规模也明显小于第二季度记录的最大交易。值得注意的是，这一疲软的交易总额也是自2022年第一季度记录的约46亿美元以来，一个完整季度内最低的生物制药并购支出。同时，第三季度单笔交易价值亦有所下降。第一季度有7笔交易的前期估值达到或超过10亿美元，第二季度增至8笔，但第三季度仅有3笔交易突破了10亿美元的门槛。这反映了近期小型并购的趋势，自2023年第一季度辉瑞以430亿美元收购Seagen以来，生物制药行业再未出现过价值300亿美元或以上的大型合并案。以下为今年第三季度生物制药领域最大的5笔并购交易。 1、礼来收购MorphicTherapeutic 7月8日，礼来宣布已与MorphicTherapeutic达成协议，将以每股57澳元/股的价格现金收购后者的所有流通股，总交易金额约为32亿美元。礼来旨在通过该笔交易增强其在胃肠道疾病领域的产品组合。 Morphic是一家专注于开发整合素靶向药物以满足严重慢性疾病需求的生物制药公司。目前，Morphic管线中仅有一款临床在研产品——用于治疗炎症性肠病（IBD）的口服小分子α4β7抑制剂MORF-057。Morphic正在开展MORF-057治疗溃疡性结肠炎（UC）的一项II期研究和治疗克罗恩病（CD）的一项II期研究。 2、勃林格殷格翰收购NerioTherapeutics 7月29日，勃林格殷格翰（BoehringerIngelheim）宣布以高达13亿美元的总额收购了Nerio Therapeutics公司，并囊获其创新蛋白酪氨酸磷酸酶N1和N2（PTPN1和PTPN2）小分子抑制剂临床前项目。勃林格殷格翰预计将该项目发展为其免疫肿瘤学产品组合的潜在核心组成，以实现改善癌症患者治疗效果的目标。 Nerio Therapeutics是一家专注于靶向磷酸酶的药物研发公司。Nerio所开发的新型、强效、潜在“first-in-class"小分子可以高选择性抑制PTPN1/2，这两个蛋白具有免疫检查点作用。通过抑制PTPN1/2，可使肿瘤对促炎信号敏感，并可增强患者免疫功能，激活免疫系统对抗癌细胞。Nerio的小分子抑制剂将成为勃林格殷格翰产品组合的重要补充，既可以作为单药疗法使用，也具潜力与该公司内部正在开发的多种癌症疗法联合使用。 3、欧加农收购Dermavant Sciences 9月18日，欧加农（Organon）宣布将收购Roivant子公司Dermavant Sciences。根据协议条款，收购总交易额约为12亿美元，包括1.75亿美元的首付款、7500万美元的监管里程碑付款以及9.5亿美元的某些商业里程碑付款。此外，欧加农将向Dermavant Sciences股东支付净销售额的分层特许权使用费。交易完成后，作为收购价格对价的一部分，欧加农将承担Dermavant Sciences的负债（截至2024年6月30日，负债约为2.86亿美元）。据悉，欧加农此次收购的主要目标是本维莫德乳膏（商品名：VTAMA），Dermavant Sciences拥有该产品在中国以外的全球权益。该交易预计将于2024年Q4完成。欧加农预计该交易不会导致其资本配置的优先级发生变化。 4、Crown Laboratories收购Revance Therapeutics 8月12日，Crown Laboratories宣布将以9.24亿美元现金收购医美小巨头Revance Therapeutics（NASDAQ: RVNC），收购价为每股6.66美元。该交易预计将于年底前完成。合并完成后，Revance将由Crown全资拥有，Revance的股票将不再在纳斯达克公开交易。 Revance是一家新兴的生物科技公司，核心资产包括一款创新的长效肉毒素注射剂DAXXIFY®（DaxibotulinumtoxinA-lanm），该产品一经上市便引发了业界的广泛关注。此次交易是医美领域的一次强强整合，通过此次合并，Revance与Crown将共同构建起护肤品领域内最为广泛和强大的分销网络之一，进一步巩固并扩大其市场版图。 5、大冢制药收购Jnana Therapeutics 8月1日，大冢制药（Otsuka）和Jnana Therapeutics共同宣布，双方已达成最终协议，大冢制药将收购Jnana公司，使其成为大冢制药子公司Otsuka America的全资子公司。根据协议条款，大冢制药将在收购完成后向Jnana公司的股东支付8亿美元，以及高达3.25亿美元的开发和监管里程碑。此次收购预计将在2024财年第三季度完成。基于此次收购，大冢制药将获得潜在“first-in-class”小分子抑制剂JNT-517，并扩展其自身免疫产品组合以及药物发现技术。JNT-517是一款在研的治疗苯丙酮尿症（PKU）的口服药物。2024年1月，Jnana公司宣布JNT-517在治疗PKU患者的1期临床试验中获得具有统计学意义的积极中期结果，该结果支持JNT-517在2025年上半年开始关键性3期临床试验。参考资料： [1]Q3 Round up:Two out of Three Ain't Bad OCTOBER-2024-Evaluate. [2]32亿美元！礼来收购Morphic，持续进军炎症性肠病领域.医药魔方.2024年07月09日. [3]勃林格殷格翰13亿美元囊获潜在“first-in-class"抗癌小分子.药明康德.2024年07月30日. [4]欧加农12亿美元收购Dermavant，获得本维莫德乳膏权益.医药魔方.2024年09月19日. [5]9.24亿美元！这家医美企业被溢价111%收购.动脉新医药.2024年08月13日. [6]超11亿美元！大冢制药收购一家自身免疫创新药公司.医药观澜.2024年08月01日. 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。点赞本文！

并购抗体药物偶联物临床2期

2024-04-10

·PRNewswire

Crown Aesthetics Wins 2024 Excellence in Customer Service Award

Emphasizing Commitment to Exceptional Customer Experiences in the Aesthetics Industry DALLAS, April 10, 2024 /PRNewswire/ -- Crown Aesthetics ("Crown"), a Crown Laboratories, Inc. company, is proud to announce that it has won the 2024 Excellence in Customer Service Award presented by Business Intelligence Group. This recognition underscores the company's unwavering commitment to delivering exceptional customer experiences and signifies its position as a leader in the industry. Crown strives to provide best in class products that are supported by continuous education and marketing support to drive patients into medical practices. With an impressive legacy of innovative aesthetic skincare solutions such as SkinPen® Precision, the first FDA-cleared microneedling system, and BIOJUVE™, a breakthrough topical regimen that optimizes skin health through the skin's microbiome, Crown differentiates itself through its unparalleled support to ensure its customers' success. "We are truly honored to receive the Excellence in Customer Service Award," said Michael McKenna, Executive Vice President and General Manager of Crown Aesthetics. "This achievement is a reflection of the hard work and dedication of our entire team who consistently strive to provide our customers with the best possible experience. While we may not be perfect, we continually seek opportunities for improvement, learning valuable lessons along the way, always listening to our customers. We remain committed to maintaining a high standard of excellence and continuing to exceed expectations in the years to come." "Receiving this award validates our dedication to excellence," said Angela Wilson McDonald, Global VP, Education and Customer Success. "It also serves as reassurance to both current and prospective customers that they can expect nothing less than outstanding service when they choose Crown. In an increasingly competitive market where our customers and their patients have numerous options available to them, providing outstanding service is essential for building trust and loyalty. I'm proud of what our team has accomplished." "In today's dynamic environment, customer service teams and suppliers have had to adapt significantly," said Maria Jimenez, Chief Nominations Officer at the Business Intelligence Group. "We're thrilled to recognize Crown for their exemplary leadership and impactful contributions to improving everyday lives." The Excellence in Customer Service Awards celebrate those who are winning by supporting their own customers and those who are developing the tools to help others find success. Awards were given out to consultants, outsource partners and technology providers for superior performances in the past 12 months. About Crown Aesthetics Crown Aesthetics, the premier medical aesthetics company, is dedicated to helping leading practices around the world grow their businesses. We do that by delivering dramatic results in rejuvenation and restoration. Our minimally-invasive innovations – SkinPen®, the first FDA-cleared microneedling device; MicroPen EVO™, also FDA-cleared; BIOJUVE™, a novel skin biome brand; a platelet-rich plasma (PRP) system ProGen PRP® Eclipse; and VOTESSE®, a hair health system - act as "gateway" products that drive new and highly satisfied patients into practices. Based in Dallas, Texas, Crown Aesthetics sets industry standards for efficacy, safety, and innovation. As a result, our customers consistently deliver the best aesthetic care in the business. For more information, please visit . About Crown Laboratories, Inc. Crown, a privately held, fully integrated global skincare company, is committed to developing and providing a diverse portfolio of aesthetic, premium, and therapeutic skincare products that improve the quality of life for its consumers throughout their skincare journey. An innovative company focused on skin science for life, Crown's unyielding pursuit of delivering therapeutic excellence and enhanced patient outcomes is why it has become a leader in Dermatology and Aesthetics. Crown has been listed on the Inc. 5000 Fastest Growing Privately Held Companies List for ten years and has expanded its distribution to over 50 countries. For more information, visit . SOURCE Crown Laboratories, Inc.

上市批准

2024-03-21

·PRNewswire

SkinPen® Precision Wins Prestigious Aesthetics Awards 2024 for "Best Energy Device of the Year"

DALLAS, March 21, 2024 /PRNewswire/ -- Crown Aesthetics, a Crown Laboratories company and a leading innovator in the medical device industry, is thrilled to announce that the first FDA-cleared microneedling device, SkinPen® Precision, has been awarded the highly coveted title of Best Energy Device of the Year. This prestigious award recognizes the remarkable impact SkinPen Precision has had in advancing healthcare through cutting-edge technology and superior patient outcomes. Continue Reading SkinPen Award The Aesthetics Awards are the most prestigious and longest-standing awards ceremony in the UK medical aesthetics specialty. They strive to promote and recognize the best of the best in the field of aesthetics. SkinPen Precision secured the top spot for its supreme efficacy, safety, and patient satisfaction. Backed by over 90 clinical studies and extensive clinical data, SkinPen Precision is a game-changer in the aesthetics' landscape. "We are incredibly proud to receive this esteemed recognition," said Andy Moulton, Vice President of International Sales for Crown Aesthetics. "This award is a testament to our unwavering commitment to innovation and excellence in healthcare. SkinPen Precision embodies our dedication to improving patient outcomes, and we are honored to see its impact acknowledged on such a significant platform." SkinPen Precision is a preferred choice among healthcare professionals worldwide. It has consistently delivered outstanding results for over five years, empowering patients to achieve optimal skin health. FDA Clearance – Medical Device Class II In the US, SkinPen Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older. CE Mark – Medical Device Class IIa: Medical Purpose: SkinPen Precision Microneedling System is a medical device intended to treat facial acne scars in adults aged 22 years or older. Aesthetic Purposes: SkinPen Precision Microneedling System is also intended to help improve the cosmetic appearance of fine lines, wrinkles, stretch marks, surgical scars, enlarged pores and pigmentation conditions (dyschromia). Indications and body treatment areas for SkinPen Precision may vary based on your country. For more information about SkinPen Precision, please visit . About Crown Aesthetics Crown Aesthetics, the premier medical aesthetics company, is dedicated to helping leading practices around the world grow their businesses. We do that by delivering dramatic results in rejuvenation and restoration. Our minimally-invasive innovations – SkinPen® Precision, the first FDA-cleared microneedling device; MicroPen EVO™, also FDA-cleared; BIOJUVE™, a novel skin biome brand; a platelet-rich plasma (PRP) system ProGen PRP® Eclipse; and VOTESSE®, a hair health system - act as "gateway" products that drive new and highly satisfied patients into practices. Based in Dallas, Texas, Crown Aesthetics sets industry standards for efficacy, safety, and innovation. As a result, our customers consistently deliver the best aesthetic care in the business. For more information, please visit . About Crown Laboratories, Inc. Crown, a privately held, fully integrated global skincare company, is committed to developing and providing a diverse portfolio of aesthetic, premium, and therapeutic skincare products that improve the quality of life for its consumers throughout their skincare journey. An innovative company focused on skin science for life, Crown's unyielding pursuit of delivering therapeutic excellence and enhanced patient outcomes is why it has become a leader in Dermatology and Aesthetics. Crown has been listed on the Inc. 5000 Fastest Growing Privately Held Companies List for ten years and has expanded its distribution to over 50 countries. For more information, visit . Photo - Logo -