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Statistical Methods for Assessment of Complex Generic Drugs
Published in Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow, Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
BE studies with clinical endpoints are relatively expensive and require large numbers of subjects. Therefore, if there exist acceptable PK or PD endpoints, these endpoints can be preferred. For instance, for topical dermatologic corticosteroid drug products, BE can be established using in vivo PD studies. The PD endpoint for dermatologic corticosteroid drug products is obtained through the McKenzie-Stoughton Vasoconstrictor Assay (VCA) approach (Smith et al., 1993). The VCA approach is based on the fact that a corticosteroid product will cause vasoconstriction of the skin microvasculature and consequently will produce a visible blanching response over time. Note that the VCA approach is limited only to dermatologic corticosteroid drug products. Mometasone furoate cream is a representative of this category. For BE assessment of mometasone furoate cream, both a pilot and pivotal vasoconstrictor study are recommended. The aim of the pilot study is to determine the appropriate dose duration for use in the subsequent pivotal BE study (US FDA, 2016c).
Monographs of Topical Drugs that Have Caused Contact Allergy/Allergic Contact Dermatitis
Published in Anton C. de Groot, Monographs in Contact Allergy, 2021
A 70-year-old patient presented with contact dermatitis on the right forearm and hands 7 days after application of mometasone furoate 0.1% cream because of granuloma annulare. Patch testing was positive to the cream and several corticosteroids (which he had apparently never used). A ROAT with the cream was strongly positive after 3 days. Further patch testing yielded positive reactions to mometasone furoate at 0.01% and 0.1% pet. (3).
Radiotherapy: The Prevention of Secondary Effects, Radiodermatitis, and Long-Term Toxicity
Published in Paloma Tejero, Hernán Pinto, Aesthetic Treatments for the Oncology Patient, 2020
Multiple prospective randomized trials have established that topical corticosteroids are effective in decreasing radiation dermatitis in patients with breast cancer [11,12,14]. Kole et al. [5] evaluated the effect of mometasone furoate for the prevention of radiation dermatitis. These results have been validated in two larger recent studies that tested the efficacy of mometasone furoate. The preventive effect of betamethasone on radiation dermatitis has been observed in both conventional and hypofractionated radiation environments. Some nonsteroidal agents have shown promise. Silver sulfadiazine cream 3 days per week during RT and for 1 week after showed a reduction of the dermatitis rates compared to a control group without intervention [5].
Topical prebiotics/postbiotics and PRURISCORE validation in atopic dermatitis. International study of 396 patients
Published in Journal of Dermatological Treatment, 2023
Carlo Gelmetti, Corinna Rigoni, Alessandra Maria Cantù, Antonina Agolzer, Alice Agrusa, Michela Brena, Federica Dall’Oglio, Patrizia Demichelis, Sandra Farina, Lucretia Adina Frasin, Sandra Lorenzi, Giuseppina Mazzola, Marisa Praticò, Stefania Robotti, Aurora Tedeschi, Lucia Villa, Prodromos Ananiadis, Eirini Arkoumani, Iulia Astashonok, Eulalia Baselga Torres, Sidita Borici, Elna Cano, Rozana Cela, Amarda Cengo, Francisca Corella, Xavier Cubiro Raventos, Miriam America De Jesus Silva, Ermira Demiraj, Entela Dhima, Xhiljola Doci, Anna Domarad, Marina Didyk, Albana Dyli, Ourania Efthimiou, Georgia Filippi, Víctor-Adrian Flores Climente, Maria Pilar Garcia Muret, Javier Garcia Navarro, Migena Gega, Aristea Noura Giakoub, Vasileios Giakoubis, Amarda Gica, Marjeta Gjomema, Blerina Guri, Elmijola Janushaj, Antonios Kanelleas, Georgia Kanelopoulou, Entela Kapaj, Dorothea Kapoukranidou, Konstantina Karadima, Athina Katsavou, Lena Kotrulja, Aikaterini Kyriakou, Georgios Larios, Anna Lopez, Cristina Lopez, Sofia Magdalini Manoli, Tatiana Matvienko, Liljana Mervic, Konstantinos Mileounis, Diana Muja, Milkota Nadezhda, Despoina Panagioti, Markos Papakonstantis, Maria Papanikou, Despoina Papathemeli, Kyriaki Papigkioti, Violetta Pivak, Driada Preza, Esther Roé, Mirjam Rogl Butina, Esther Serra Baldrich, Dimitrios Sgouros, Aleksandra Shilova, Eljona Shllaku, Nikolaos Sideris, Ermal Sina, Ardiana Sinani, Fani Sourli-Chasioti, Mirsa Stankaj, Dimitra Tasioula, Athanasios Tsalmadoupis, Fragkiski Tsatsou, Eftichia Tsenebi, Anastasia Tsitlakidou, Politimos Vassis, Eva Vilarrassa, Olga Vorobey, Nikolaos Voutsakis, Svetlana Yakovleva, Svetlana Yakubovskaya, Ekaterina Yerygina, Alexios Zarras, Valbona Zenelaj, Olga Zenko
About 402 subjects, enrolled in 8 European countries, were involved in the study and followed over time for approximately 3 months. After the data-cleaning phase, 6 subjects (1.5%) were excluded from the analysis because they lacked information at baseline. The study is therefore based on a total of 396 subjects of both sexes suffering from Atopic Dermatitis defined according to Hanifin and Rajka’s criteria and recruited from the following countries indicated in Table 2 who met the following inclusion criteria were studied:Male and female sex.Mild and/or moderate AD according to the SCORAD index (9).Patients who may use topical treatment, preferably with mometasone furoate 0.1% cream as needed.Signature of informed consent to participate in the study.
Safety review of current systemic treatments for severe chronic rhinosinusitis with nasal polyps and future directions
Published in Expert Opinion on Drug Safety, 2021
Biological agents are medicines produced by a biological process. Monoclonal antibodies (mAB) are one type of biologic that are becoming more widely used in the treatment of inflammatory conditions where pharmacological therapy does not provide adequate symptom control. They target specific inflammatory mediators or immune cells in the pathophysiological pathways that produce chronic inflammatory diseases [99]. Studies have evaluated mAB in conditions such as asthma and atopic dermatitis leading to increasing interest that these agents may also offer some benefit in treating patients with CRSwNP. All currently available biologics used in the treatment of CRSwNP are given by injection. It should also be noted that biologics are considered as an add-on treatment for severe CRSwNP, given in addition to an intranasal corticosteroid. In all trials discussed below, mometasone furoate spray was given as a maintenance treatment in both active and placebo treatment arms and therefore adverse events may be attributable to this in both arms.
A decade retrospective study of light/laser devices in treating nasal rosacea
Published in Journal of Dermatological Treatment, 2020
Yanping Zhang, Shibin Jiang, Yansong Lu, Wu Yan, Hongwei Yan, Yuanyuan Xu, Tianhua Xu, Yuanhong Li, Long Geng, Xinghua Gao, Hongduo Chen
Before treatment, the makeup of each patient was removed and cleaned with a neutral cleanser. Immediately after light/laser treatment, an ice pack was used for at least 30 min to cool the skin surface. The fundamental skin care products including a mild moisturizer and a broad-spectrum sunscreen (sun protection factor, SPF ≥ 30, protection of ultraviolet A, PA++/+++) were applied during the whole period. Triggering factors for rosacea such as spicy foods, emotion fluctuation, overheated environment, intense and direct sun exposure, or others were required to avoid. Specifically for FCO2 laser, before treatment, an anesthetic compound lidocaine cream (Tsinghua Unisplendour Corporation Limited, Beijing, China) was topically applied under occlusion for 1 h. In addition, after treatment, an antibiotic ointment fusidic acid (LEO Pharma, Barcelona, Spain) and a recombinant human epidermal growth factor gel (Pavay Gene Pharmaceutical Co., Ltd., Guilin, China) were topically applied four times a day for 1 week, respectively, and a corticosteroid cream mometasone furoate (Schering-Plough, NJ, Shanghai, China) was topically applied twice a day for 3 days.