Article
Dermatology
Pooja Sodha, Amanda Suggs, Girish S. Munavalli, Paul M. Friedman
Summary: The study demonstrated significant improvement in erythematotelangiectatic rosacea patients with the combination of oxymetazoline therapy and 595-nm PDL, showing better outcomes in terms of CEA improvement, vessel size reduction, and GAI scores compared to oxymetazoline therapy alone.
LASERS IN SURGERY AND MEDICINE
(2021)
Article
Dermatology
Chanudda Washrawirul, Thanaporn Puaratana-arunkon, Yuda Chongpison, Nopadon Noppakun, Pravit Asawanonda, Chanat Kumtornrut
Summary: The study confirmed the effectiveness and safety of topical oxymetazoline hydrochloride (OxH) 0.05% solution for post-acne erythema (PAE), showing reduction in PAE lesion counts, improved clinical response rate, and higher patient satisfaction.
JOURNAL OF DERMATOLOGY
(2023)
Article
Pharmacology & Pharmacy
Yvette N. Lamb
Summary: Imeglimin hydrochloride is an orally administered first-in-class glimin with glucose-lowering effects approved for use in type 2 diabetes in Japan. Its development milestones leading to this approval include positive results from the pivotal phase III TIMES program.
Article
Pharmacology & Pharmacy
Connie Kang
Summary: Keverprazan hydrochloride, developed by Jiangsu Carephar Pharmaceuticals, is a potassium ion competitive acid blocker used for the treatment of acid-related diseases. It has recently been approved in China for the treatment of reflux esophagitis and duodenal ulcer in adults. This article summarizes the development milestones of keverprazan hydrochloride leading to its first approval for reflux esophagitis and duodenal ulcer treatment.
Article
Oncology
Denise Casey, Suzanne Demko, Arup Sinha, Pallavi S. Mishra-Kalyani, Yuan-Li Shen, Sachia Khasar, M. Anwar Goheer, Whitney S. Helms, Lili Pan, Yuan Xu, Jianghong Fan, Ruby Leong, Jiang Liu, Yuching Yang, Katherine Windsor, Mei Ou, Olen Stephens, Byeongtaek Oh, Gregory H. Reaman, Abhilasha Nair, Stacy S. Shord, Vishal Bhatnagar, Selena R. Daniels, Sharon Sickafuse, Kirsten B. Goldberg, Marc R. Theoret, Richard Pazdur, Harpreet Singh
Summary: The FDA approved selumetinib for pediatric patients with neurofibromatosis type 1 who have inoperable plexiform neurofibromas. The approval was based on a single-arm multicenter trial showing clinical improvements and a durable overall response rate. The risks of selumetinib are consistent with MEK inhibitor class effects, with favorable benefit-risk assessment for patients with inoperable plexiform neurofibromas.
CLINICAL CANCER RESEARCH
(2021)
Letter
Dermatology
Arcadi Altemir, Maribel Iglesias-Sancho, Cristina Barrabes-Torrella, Manuel Sanchez-Regana, Montse Salleras-Redonnet
Summary: Erythromelalgia is a rare syndrome that has a significant impact on quality of life, and its management is often challenging. This study presents the first case of erythromelalgia successfully treated with topical oxymetazoline.
CLINICAL AND EXPERIMENTAL DERMATOLOGY
(2022)
Article
Oncology
Elizabeth S. Duke, Amy K. Barone, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Yuan-Li Shen, Emasenyie Isikwei, Hong Zhao, Youwei Bi, Jiang Liu, Nam Atiqur Rahman, Emily Wearne, John K. Leighton, Maritsa Stephenson, Idara Ojofeitimi, Barbara Scepura, Abhilasha Nair, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Summary: On September 17, 2021, the FDA approved cabozantinib for the treatment of RAI-refractory locally advanced or metastatic differentiated thyroid cancer. The approval was based on data from an international trial, which showed that cabozantinib significantly prolonged progression-free survival compared to placebo.
CLINICAL CANCER RESEARCH
(2022)
Article
Pediatrics
Richard Cartabuke, Joseph D. Tobias, Kris R. Jatana
Summary: Oxymetazoline is used in pediatric patients for various conditions in the operating room, but caution is needed due to potential systemic adverse effects. While FDA approval is for patients >= 6 years old, off-label short-term use in younger children may occur in certain clinical scenarios. Further research is needed to understand its absorption and effects in children.
Review
Dermatology
Nwanneka Okwundu, Abigail Cline, Steven R. Feldman
Summary: Topical oxymetazoline and brimonidine have been found to be effective in treating persistent facial erythema associated with rosacea, with mild and localized adverse effects. Further long-term research is necessary to understand their long-term effects.
JOURNAL OF DERMATOLOGICAL TREATMENT
(2021)
Review
Medicine, General & Internal
Jonathan J. Darrow, Jerry Avorn, Aaron S. Kesselheim
Summary: Medical device regulation in the US has become more complex over the past 45 years, with various regulatory pathways and evolving evidence requirements. Increased FDA support from industry and concerns about flexible authorization requirements highlight the ongoing tension between efficient access and ensuring patient safety.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
(2021)
Article
Dermatology
Emil A. Tanghetti, David J. Goldberg, Jeffrey S. Dover, Roy G. Geronemus, Zane Bai, Nancy Alvandi, Stuart D. Shanler
Summary: The study evaluated the safety and efficacy of oxymetazoline hydrochloride cream, 1% as an adjunctive treatment for patients with moderate to severe facial erythema associated with rosacea. The results showed significant improvement in patients' condition and high levels of satisfaction with the treatment.
LASERS IN SURGERY AND MEDICINE
(2021)
Article
Oncology
Vaibhav Kumar, Leslie Doros, Margaret Thompson, Sirisha L. Mushti, Rosane Charlab, Elizabeth I. Spehalski, Hong Zhao, Matthew D. Thompson, Shenghui Tang, Richard Pazdur, Steven J. Lemery, Marc R. Theoret, Lola A. Fashoyin-Aje
Summary: On May 15, 2020, the FDA approved ripretinib for adult patients with advanced gastrointestinal stromal tumor who have received prior treatment with three or more kinase inhibitors, including imatinib. The approval was based on results from the INVICTUS trial, which showed a significant improvement in progression-free survival for patients in the ripretinib group compared to the placebo group. The median overall survival was also longer in the ripretinib group.
CLINICAL CANCER RESEARCH
(2023)
Article
Dermatology
Naglaa Agamia, Sara El-Nagdy, Aly El-Ariny
Summary: The combination of tranexamic acid, oxymetazoline, and brimonidine is an effective and safe treatment for reducing persistent post acne erythema.
DERMATOLOGIC THERAPY
(2022)
Article
Dermatology
Ben Wang, Yingxue Huang, Yan Tang, Zhixiang Zhao, Wei Shi, Dan Jian, Fangfen Liu, Qiong Gao, Peiru Wang, Jie Yang, Lin Li, Hongfu Xie, Ji Li
Summary: This study evaluated the efficacy and safety of a 12-week treatment with paroxetine for refractory erythema of rosacea. The results showed that the proportion of participants who achieved treatment success was significantly higher in the paroxetine group compared to the placebo group. Paroxetine also improved other symptoms and was well-tolerated. Paroxetine is an effective alternative treatment for moderate-to-severe erythema of rosacea.
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
(2023)
Article
Dermatology
Martin Schaller, Simon Riel, Rawad Bashur, Nithin Kurup, Harald Schnidar, Birgit Fehrenbacher
Summary: Ivermectin 1% cream is effective in treating papules and pustules as well as improving erythema and invisible skin symptoms in patients with rosacea.
DERMATOLOGIC THERAPY
(2022)
Review
Pharmacology & Pharmacy
Alexandra Taylor, Rohan Singh, Steven R. Feldman
Summary: This review highlights the pharmacokinetics, efficacy, and safety of recently approved calcipotriene and betamethasone dipropionate (C-BD) cream in the treatment of psoriasis. The results showed that C-BD cream was effective and safe, with higher treatment success rates compared to C-BD topical suspension and vehicle. The use of C-BD cream provides a convenient and preferred option for patients with mild-to-moderate psoriasis.
ANNALS OF PHARMACOTHERAPY
(2023)
Review
Pharmacology & Pharmacy
Lindsey A. Mohney, Rohan Singh, Steven R. Feldman
Summary: This study reviews the pharmacokinetics, efficacy, and safety of a newly approved topical Janus kinase 1 (JAK) inhibitor, ruxolitinib (RUX), in patients with atopic dermatitis (AD). The results suggest that RUX is an effective and safe therapy for AD in adult patients.
ANNALS OF PHARMACOTHERAPY
(2023)
Review
Pharmacology & Pharmacy
Rohan Singh, Alexandra Taylor, Milaan A. Shah, Lindsay C. Strowd, Steven R. Feldman
Summary: This study reviewed the pharmacokinetics, efficacy, and safety of tralokinumab in the treatment of atopic dermatitis (AD). Data analysis demonstrated that tralokinumab is effective and safe as a monotherapy, in combination with topical corticosteroids (TCS), and in patients with resistance or contraindication to oral cyclosporine. Tralokinumab, which is associated with overexpression of IL-13, is an efficacious systemic treatment for moderate-to-severe AD.
ANNALS OF PHARMACOTHERAPY
(2023)
Review
Pharmacology & Pharmacy
Jessica N. Pixley, Taylor Schaetzle, Steven R. Feldman
Summary: This article reviews clinical trials on the efficacy, safety, and clinical application of once-daily roflumilast 0.3% cream for plaque psoriasis treatment. The results show that roflumilast is effective and safe, and it has potential as a nonsteroidal alternative to topical corticosteroids.
ANNALS OF PHARMACOTHERAPY
(2023)
Editorial Material
Dermatology
Heli Patel, Steven R. Feldman
AMERICAN JOURNAL OF CLINICAL DERMATOLOGY
(2023)
Review
Pharmacology & Pharmacy
Christopher Alihosseini, Hannah Kopelman, Mallory Zaino, Steven R. Feldman
Summary: This study reviewed the safety and efficacy of avacopan for the treatment of ANCA-associated vasculitis. The results showed that avacopan can improve remission rates and reduce side effects caused by steroid use. Therefore, avacopan may be a new option for the treatment of ANCA-associated vasculitis.
ANNALS OF PHARMACOTHERAPY
(2023)
Review
Pharmacology & Pharmacy
Meghan C. Grossmann, Jessica N. Pixley, Steven R. Feldman
Summary: This article reviews the efficacy and safety of 1% tapinarof cream for plaque psoriasis. The results of two 12-week phase III clinical trials showed that around 35.4% to 40.2% of patients achieved clear or almost clear disease severity at week 12. In the 40-week, open-label extension trial, 40.9% of patients achieved a Physician's Global Assessment (PGA) score of 0 at least once. Tapinarof may be an effective and safe topical treatment for mild to severe plaque psoriasis.
ANNALS OF PHARMACOTHERAPY
(2023)
Letter
Dermatology
William B. Song, Gabrielle M. Peck, Aakriti Neopaney, Daniel B. Shin, Alan B. Fleischer Jr, Steven R. Feldman, Joel M. Gelfand, Hideki Mochizuki, James T. Elder, Yukinori Okada
JOURNAL OF INVESTIGATIVE DERMATOLOGY
(2023)
Review
Pharmacology & Pharmacy
Diem-Phuong D. Dao, Jessica N. Pixley, Zeynep M. Akkurt, Steven R. Feldman
Summary: This article evaluates the effectiveness, safety, pharmacology, and clinical applications of topical sirolimus 0.2% gel for treating tuberous sclerosis complex (TSC)-associated facial angiofibromas. The gel showed improvement in tumor size and redness without any serious adverse events. It is considered a safe and effective noninvasive alternative to surgical procedures for TSC-related angiofibromas.
ANNALS OF PHARMACOTHERAPY
(2023)
Letter
Dermatology
Jessica N. Pixley, Mallory L. Zaino, Christina L. Kontzias, Rachel E. Tao, Steven R. Feldman
Summary: This study aimed to determine if showing patients their facial characteristics using an AI application would increase their use of sunscreen. The findings showed a decrease in self-reported sunscreen usage after the study, while skincare product usage remained unchanged.
CLINICAL AND EXPERIMENTAL DERMATOLOGY
(2023)
Letter
Dermatology
Emily A. Parks, Mallory L. Zaino, Jessica N. Pixley, Vani Mangalam Subramanian, Deepak Sirdeshmukh, Steven R. Feldman, Rita O. Pichardo
JOURNAL OF DERMATOLOGICAL TREATMENT
(2023)
Article
Dermatology
Rachel E. Tao, Jessica N. Pixley, Phillip G. Holovach, Alan B. Fleischer Jr, Steven R. Feldman
Summary: Off-label treatments are commonly used for pediatric psoriasis, with topical treatments, especially unapproved tacrolimus, being the most common approach. This may indicate a hesitance to use corticosteroids in children.
DERMATOLOGY AND THERAPY
(2023)
Review
Infectious Diseases
Rachel E. Tao, Stuti Prajapati, Jessica N. Pixley, Ayman Grada, Steven R. Feldman
Summary: Tetracycline-class drugs are commonly used in dermatology for treating skin diseases. This study reviewed the available evidence on whether taking these drugs with food affects their absorption and clinical efficacy. The study found that co-administration with food decreased systemic absorption of tetracycline, while the impact on doxycycline and minocycline varied. Oral sarecycline showed decreased absorption with food. Only sarecycline demonstrated limited or no impact of food intake on clinical efficacy. The study suggested considering patient adherence when choosing to take doxycycline, minocycline, and sarecycline with food.
Review
Biochemistry & Molecular Biology
Heli A. A. Patel, Rishab R. R. Revankar, Sofia T. T. Pedroza, Shaveonte Graham, Steven R. R. Feldman
Summary: Understanding the genetic factors in psoriasis can help improve targeted treatment strategies. This review discusses the genes associated with psoriasis pathogenesis and their connection to available treatment options. Searching various databases, relevant genetic markers and treatments were identified. Gene variants involved in inflammatory pathways, such as interleukins and interferons, are commonly implicated in psoriasis. Some treatments, like IL23 and TYK2 inhibitors, target genes associated with psoriasis. Multiple genes are involved in psoriasis pathogenesis, providing potential avenues for developing new treatment strategies and improving outcomes.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
(2023)
Article
Dermatology
Rachel E. Tao, Jessica N. Pixley, Christina L. Kontzias, Steven R. Feldman
Summary: Drug efficacy is best evaluated through randomized, controlled, double-blind clinical trials, while safety assessment is more challenging. The Medical Dictionary for Regulatory Activities (MedDRA) is used to track and categorize adverse events (AE) during clinical trials. This study reviewed recent clinical trials on atopic dermatitis to demonstrate the importance of understanding MedDRA in evaluating adverse events related to herpes simplex virus (HSV) infection.
ARCHIVES OF DERMATOLOGICAL RESEARCH
(2023)