[Translation] A single-center, randomized, open-label, single-dose, parallel-design comparative pharmacokinetic study of ibuprofen methylpyrrolidone cream in humans

本试验为正式试验，旨在研究局部涂抹汕头经济特区鮀滨制药厂研制、生产的布洛芬吡甲酯乳膏（T：10 g﹕0.5 g）的药代动力学特征；以鳥居薬品株式会社生产的布洛芬吡甲酯乳膏（STADERM®，R：10 g﹕0.5 g）为参比制剂，评价受试制剂与参比制剂在布洛芬/布洛芬吡甲酯上的药动学参数（Cmax、AUC0-t、AUC0-∞）的差异性，并评价受试制剂的安全性。

[Translation]

This test is a formal test, aiming to study the pharmacokinetic characteristics of topical application of ibuprofen methylpyridin cream (T: 10 g﹕0.5 g) developed and produced by Tuobin Pharmaceutical Factory in Shantou Special Economic Zone; Ibuprofen methylpyridine cream (STADERM®, R: 10 g﹕0.5 g) produced by Co., Ltd. is a reference preparation. The test preparation and the reference preparation are evaluated on ibuprofen/ibuprofen methylpyridine. Differences in pharmacokinetic parameters (Cmax, AUC0-t, AUC0-∞), and evaluate the safety of the test preparations.

Start Date-

Sponsor / Collaborator

Shandong Bestcomm Pharmaceutical Co., Ltd.

JPRN-jRCTs061210078

/ RecruitingPhase 2IIT

Single-center, open-label, single-arm clinical study to confirm the efficacy and safety of topical delgocitinib ointment in patients with rosacea and rosacea-like dermatitis

Start Date20 Jun 2022

Sponsor / Collaborator-

NCT03878784

/ CompletedNot ApplicableIIT

Investigation of PACAP38-induced Headache and Rosacea-like Symptoms in Patients With Rosacea

The investigators aim is to investigate the incidence of headache and rosacea-like flushing after pituitary adenylate cyclase-activating peptide-38 (PACAP38) with and without treatment with sumatriptan in patients with rosacea

Start Date12 Nov 2018

Sponsor / Collaborator

Danish Headache Center

100 Clinical Results associated with Rosacea-like dermatitis

100 Translational Medicine associated with Rosacea-like dermatitis

0 Patents (Medical) associated with Rosacea-like dermatitis

166

Literatures (Medical) associated with Rosacea-like dermatitis

01 Jan 2025·International Immunopharmacology

Activation of aryl hydrocarbon receptor ameliorates degranulation of LL-37 induced mast cells in rosacea through enhancing autophagy

Article

Author: Chen, Shuyan ; Dong, Miao ; Sun, Yan ; Wu, Jinxuan ; Wang, Zi ; Zhang, Ying ; Zhu, Qiao ; Hu, Honghao ; Gao, Xinghua

BACKGROUNDActivation of the aryl hydrocarbon receptor (AhR) ameliorates LL-37-induced rosacea-like dermatitis in mice, whereas mast cells and cytokine overexpression are prominent features in rosacea skin.OBJECTIVETo evaluate the potential mechanisms of AhR activation on autophagy and degranulation of mast cells in rosacea.METHODSLL-37 treated mast cells were used to mimic rosacea. An AhR agonist (tapinarof) was applied to LL-37 induced mast cells. Furthermore, an autophagy agonist (RAPA) and an inhibitor (CQ) was added to investigate the mechanisms of autophagy. Western blot and RT-qPCR assessed cell degranulation (Cma1, Tpsab1) and cytokines (MMP9, TNF-α, and IL-6). Changes in cell morphology were observed under a microscope. Autophagy markers (LC3 and p62) were examined using Western blot and cellular immunofluorescence.RESULTSLL-37 upregulated the expressions of Cma1, Tpsab1, MMP9, TNF-α, and IL-6, which were then reduced by tapinarof treatment for 24 h. LC3B-I was converted to LC3B-II and p62 was reduced gradually with increasing concentration of tapinarof, indicating that autophagy was enhanced. RAPA enhanced the expression of LC3B-II on LL-37-induced mast cells, similar to tapinarof, while CQ partially inhibited the ability of tapinarof to induce autophagy in mast cells. Moreover, CQ reversed tapinarof's suppression of Cma1, Tpsab1, MMP9, TNF-α and IL-6 on LL-37 treated mast cells.CONCLUSIONThe present study showed that activation of AhR ameliorated degranulation of LL-37-induced mast cells in rosacea through enhancing autophagy, offering a new option for rosacea treatment.

01 Dec 2024·Immunity, Inflammation and Disease

Impaired Angiogenesis and Th1/Th17 Polarization: A Possible Explanation for the Decreased Incidence of Rosacea in the Aged

Article

Author: Long, Juan ; Chen, Mengting ; Deng, Zhili ; Liu, Tangxiele

ABSTRACTBackgroundRosacea is a common inflammatory skin disorder characterized by frequent facial flushing, erythema, telangiectasia, and papules, with a higher incidence observed in individuals aged 30−50 years and a tendency to decrease in the elderly. This age‐related decline in incidence drew our attention to further explore the relationship between rosacea pathogenesis and aging.MethodsWe analyzed the incidence of rosacea across 8340 individuals without systemic diseases. The effects of LL37‐induced rosacea‐like erythema and inflammation were evaluated in both young and aged mice. Immunofluorescence analysis was performed to assess microvessel density, whereas the expression levels of angiogenesis‐related factors, including matrix metalloproteinases (MMPs) and vascular endothelial growth factor α (VEGFα), were quantified. Additionally, immune responses were assessed at both the cellular and systemic levels.ResultsAged mice displayed milder LL37‐induced rosacea‐like erythema and inflammation compared to their young counterparts. Immunofluorescence analysis revealed a decrease in microvessel density in rosacea models of the aged group. The expression of angiogenesis‐related factors, including MMPs and VEGFα, was decreased in aged mice compared to young mice, indicating a reduced responsiveness to LL37 stimulation. Furthermore, we found that suppressed Th1‐ and Th17‐polarized immune responses, one of the major pathogenic mechanisms of rosacea, were reduced in aged mice in response to LL37 stimulation at both cellular and systemic levels.ConclusionThe findings suggest that impaired angiogenesis and attenuated Th1/Th17 immune responses underlie the age‐related decline in rosacea incidence.

15 Oct 2024·The FASEB Journal

IL‐17A‐neutralizing antibody ameliorates inflammation and fibrosis in rosacea by antagonizing the CXCL5/CXCR2 axis

Article

Author: Mao, Na ; Zhang, Chuanxi ; Liu, Heliang ; Xu, Hong ; Yang, Jie ; Zheng, Ruiping ; Jin, Hui ; Cai, Wenchen ; Gao, Xuemin ; Zhang, Ziyan ; Wu, Yiling ; Kang, Yumeng

AbstractRosacea is a chronic inflammatory skin disorder that can lead to fibrosis. However, the mechanisms underlying fibrosis in the later stages of rosacea have been less thoroughly investigated. Interleukin‐17A (IL‐17A) has been implicated in both inflammation and organ fibrosis; however, the effectiveness and mechanism of IL‐17A‐neutralizing antibodies in the later stages of rosacea‐related fibrosis remain unclear. In this study, we induced rosacea‐like lesions in mice using LL‐37 and administered IL‐17A‐neutralizing antibodies. The results indicated that the IL‐17A‐neutralizing antibodies alleviated skin damage, reduced skin thickness, and decreased the secretion of inflammatory factors (TNF‐α, CAMP, TLR4, P‐NF‐kB), angiogenesis‐related factors (CD31, VEGF), and the TGF‐β1 signaling pathway, along with factors associated with epithelial–mesenchymal transition and the deposition of fibrosis‐related proteins (COL1) in the rosacea‐like mouse models. Furthermore, the IL‐17A‐neutralizing antibodies effectively diminished the expression of IL‐17, IL‐17R, CXCL5, and CXCR2 in the skin. Our findings demonstrate that IL‐17A‐neutralizing antibodies inhibit the activation of the CXCL5/CXCR2 axis in rosacea‐like skin tissue, thereby ameliorating inflammation and fibrosis associated with the condition.

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