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Mashup Score: 1
EPI Health (Novan) is initiating a voluntary recall of various within-expiry human drug products as a result of the closures and discontinuation of the post-marketing quality, regulatory and pharmacovigilance activities for these marketed products. The moves comes after EPI filed Chapter 7 bankruptcy in July 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. The discontinuation of these post-marketing programs means the company will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product. Further distribution or use of any remaining product on the market should cease immediately. EPI Health said it has not received any reports of adverse events related to this recall. Only products and lot numbers listed below are affected by the recall. Products’ lot numbers not included are owned and distributed by a new pr
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Mashup Score: 2LEVEL UP: Upadacitinib Shows Superior Efficacy in AD - 7 day(s) ago
New topline results in evaluating the efficacy and safety of upadacitinib for adults and adolescents with moderate-to-severe atopic dermatitis (AD) who had an inadequate response to systemic therapy or when use of those therapies was inadvisable. The study, LEVEL UP, was a Phase 3b/4, multi-center, randomized, open-label, efficacy assessor-blinded study comprising a 35-day screening period, a 16-week treatment Period 1, and a 16-week treatment Period 2. During Period 1, participants were randomly assigned in one of two groups to receive upadacitinib (RINVOQ®) 15 mg QD or dupilumab as per its label. In Period 2, participants received upadacitinib as per protocol-defined criteria. The primary endpoint was the simultaneous achievement of a 90% or greater reduction in Eczema Area and Severity Index (EASI 90) and a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16. Key ranked secondary endpoints included the achievement of EASI 90 at Week 16, and the achievement of a W
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Mashup Score: 0
New research unveils the hidden impact on mental health that some chronic skin conditions take for pediatric patients. The cross-sectional study, published in JAMA Dermatology, was conducted across 32 pediatric dermatology centers in the United States and Canada and aimed to explore the extent of stigma associated with chronic pediatric skin diseases, the dependence on disease visibility and severity, and their association with mental health outcomes. Researchers included 1,671 pediatric patients aged 8 to 17 years with chronic skin conditions in the analysis, along with their parents. Using the Patient-Reported Outcomes Measurement Instrumentation System (PROMIS), they assessed stigma levels through various perspectives, including child-, caregiver-, and physician-assessed disease visibility. The study results indicated that over half of the participants reported high disease visibility, with stigma scores significantly differing based on physician and child/proxy assessments of dise
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Mashup Score: 4Impact of Alopecia Areata on Pediatric Patients and Their Families: Insights from a Single-Center Study in Turkey - 12 day(s) ago
Alopecia areata (AA) is known to impact the health-related quality of life (HRQoL) of affected individuals, yet there is a paucity of research focusing on its effects specifically in pediatric patients and their families. To address this gap, researchers recently conducted a single-center cross-sectional cohort study aimed at assessing the HRQoL of pediatric patients diagnosed with AA and evaluating its impact on their parents. Between December 2020 and December 2021, researchers enrolled 72 pediatric patients with AA from the dermatology department of a tertiary center in Turkey. They used the Children’s Dermatology Life Quality Index (CDLQI) to gauge the HRQoL of pediatric patients, and the Dermatological Family Impact Scale (DeFIS) to evaluate the impact on their parents (often primary caregivers in the disease process). The results showed a mean CDLQI score of 8.4 ± 5.3 among the pediatric cohort, indicating moderate impairment. The symptoms and feelings domain exhibited the highes
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Mashup Score: 0Oral and Topical Minoxidil for Male Androgenetic Alopecia Show Similar Efficacy: Analysis - 15 day(s) ago
Low-dose oral minoxidil (5 mg once daily) was found to have similar effectiveness to topical minoxidil (5% twice per day) for the treatment of male androgenetic alopecia (AGA). The authors conducted the double-blind, placebo-controlled randomized clinical trial in Brazil aiming to evaluate the efficacy, safety, and tolerability of low-dose oral minoxidil compared to topical minoxidil in treating male AGA. The study included 90 men aged 18 to 55 years with AGA classified as 3V, 4V, or 5V on the Norwood-Hamilton scale. Participants were randomized into one group receiving daily oral minoxidil (5 mg) and topical placebo, and the other group receiving topical minoxidil (5%) twice daily and oral placebo. The study period was 24 weeks. Primary outcome measures included change in terminal hair density on the frontal and vertex regions of the scalp, with secondary outcomes including changes in total hair density and photographic evaluation. Of the 90 enrolled participants, 68 completed the st
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Mashup Score: 0
A single session of treatment with a fractional carbon dioxide laser followed by botulinum toxin type A was associated with significant reduction of facial pores in a pilot study presented at the American Society for Laser Medicine and Surgery (ASLMS) 43rd Annual Conference on Energy-based Medicine and Science in Baltimore. Enlarged facial pores are a common aesthetic concern, and fractional carbon dioxide (FxCO2) has shown success in minimizing pore size, but its use in combination with intradermal botulinum toxin type A (BTX-A) has not been examined, wrote Nattaporn Sampattavanich, MD, of Phramongkutklao Hospital, Bangkok, Thailand, and colleagues in an abstract presented at the annual conference of the American Society for Laser Medicine and Surgery. The researchers conducted a split-face pilot study of 15 adults with large facial pores. All participants underwent an initial session of FxCO2 applied to both cheeks, followed immediately by an injection of 16 units of BTX-A in one che
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Mashup Score: 0Top Non-cosmetic Laser Indications Vary by Laser Type - 19 day(s) ago
Treatment of psoriasis, vascular lesions, and hypertrophic disorders were the most common non-cosmetic indications for dermatologic use of excimer, vascular, and ablative lasers, respectively, based on data from more than 55,000 individuals. Non-cosmetic laser therapy in dermatology has experiencing significant growth in recent years, but the demographics and indications have not been examined, wrote Serena Yun-Chen Tsai, MD, of Harvard University, Boston, and colleagues in an abstract presented at the annual conference of the American Society for Laser Medicine and Surgery. In a population-based study, the researchers reviewed electronic health records for 56,784 adult patients who underwent non-cosmetic laser therapy (excimer, ablative, or vascular) at 92 healthcare organizations in the United States between January 2013 and December 2023. Overall, the mean age of the patients was 45.3 years, and half were female. Among the 42,898 patients underwent excimer laser therapy, psoriasis w
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Mashup Score: 0
In this episode of DermWire TV, a new analysis highlights factors affecting long-term antibiotic prescriptions for acne; a company developing plaque psoriasis biologics makes a major acquisition; and Practical Dermatology launches two new video series focusing on advancing treatment and improving understanding of atopic dermatitis. (AD), as well as a new series of C-Suite interviews.
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In this episode of DermWire TV, a new analysis highlights factors affecting long-term antibiotic prescriptions for acne; a company developing plaque psoriasis biologics makes a major acquisition; and Practical Dermatology launches two new video series: https://t.co/bZ2FDE3Lz4 https://t.co/RquoFFm2Tv
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Mashup Score: 1
A recent analysis of the phase 1b KEYNOTE-041 trial indicated effectiveness and tolerability of pembrolizumab in Japanese patients with advanced melanoma. Researchers conducted the study over a 12-month period. The study evaluated pembrolizumab’s long-term efficacy and safety in individuals with locally advanced (unresectable stage III) or metastatic (stage IV) melanoma who were ineligible for local therapy. Patients had all received limited prior systemic treatments. The study drug was administered at a dosage of 2 mg/kg every 3 weeks for up to 2 years or until confirmed disease progression or intolerable side effects. According to the results, pembrolizumab exhibited a promising overall response rate (ORR) of 24.3% among evaluable patients, with two patients achieving complete response following initial partial response. Median overall survival (OS) reached 25.1 months, with a 30-month OS rate of 46.3%, indicating durable antitumor activity. Furthermore, the median duration of respon
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Mashup Score: 1
Deucravacitinib, a TYK-2 inhibitor, was linked with significant improvements in patient-reported outcomes (PROs) in patients with active psoriatic arthritis (PsA), according to results from a phase 2 trial. To assess the effects of deucravacitinib in this patient population, the study authors conducted a double-blind and randomized trial that included 203 patients with active PsA who were assigned to receive either deucravacitinib at doses of 6 mg or 12 mg once daily or a placebo over a period of 16 weeks. Key secondary endpoints included changes from baseline at Week 16 in the Health Assessment Questionnaire Disability Index (HAQ-DI) and the 36-item Short Form Health Survey (SF-36) physical component summary (PCS) score. Additional PROs (fatigue, pain, and mental health) were also assessed. The results showed that both doses of deucravacitinib led to significant improvements in HAQ-DI and SF-36 PCS scores compared to the placebo group. Moreover, a higher proportion of patients receivi
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EPI Health (Novan) is initiating a voluntary recall of various within-expiry human drug products as a result of the closures and discontinuation of the post-marketing quality, regulatory and pharmacovigilance activities for these marketed products: https://t.co/p54vKGCMSQ