A Self-controlled Trial of Prophylactic Topical Application of Vitamin K1 Cream for Cetuximab-related Skin Rash -VANQUISH trial-
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Cancer
PROVIDER: 2625669 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:We have previously shown that nano-sized graphene oxide (NGO) displays anti-inflammatory activities against natural killer T (NKT) cell-mediated sepsis. To address whether NGO could be applied to treat acute skin inflammation. We developed a conventional skin Cetaphil® cream containing NGO (NGO cream) for topical application to skin lesions and investigated its therapeutic efficacy by employing the tape-stripping-induced acute skin inflammation model. Topical application of NGO cream to the wounded area significantly reduced skin lesions compared with the control cream. Moreover, NGO cream treatment prevented the tape-stripping-elicited infiltration of and IL1β production by skin neutrophils and dendritic cells (DCs). Furthermore, such anti-inflammatory effects of NGO cream were attributed to decreased infiltration of IL12-producing DCs and IFNγ-producing cells (e.g., CD4+ T, CD8+ T, γδ T, NK, and NKT cells) into the skin. In addition, topical NGO cream administration enhanced the expression of suppressive molecules such as FR4 on skin regulatory T cells. Through RNA sequencing analysis, we found that the preventive effect of NGO cream on acute skin inflammation may be correlated with the activation of keratinocytes located in the epidermis. Our results support NGO cream as a therapeutic option to control acute skin inflammation.
2024-08-20 | GSE272008 | GEO
Project description:The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab.
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Project description:The purpose of this study is to determine if using preventive treatments such as Doxycycline (an anti-biotic) capsules, sunscreen with SPF 30, Hydrocortisone 1% cream and a moisturizer will help to reduce the incidence and severity of the skin rash associated with Cetuximab (Erbitux) when compared to receiving standard care for the treatment of skin rash.
| 2146434 | ecrin-mdr-crc
Project description:The MEK inhibitor selumetinib induces objective responses in children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PNs). We conducted an open-label phase 2 study of selumetinib in 33 adults with PNs (NCT02407405). The objective response rate was 72.7% (24/33 patients). Median tumor volume decrease at best response was 23.6% at data cut-off with 19 patients continuing to receive study treatment. Acneiform rash was the most common adverse event (AE, 33/33 patients, 15 grade ≥2); acneiform rash and increases of ALT, AST, CPK, and lipase were the only grade 3/4 AEs to occur in more than 1 patient. Patients report improved pain levels and quality of life. Phosphorylation of ERK1/2 decreased significantly in paired biopsies (P≤0.0003) without compensatory phosphorylation of AKT1/2/3 (P =0.0697-0.9587). Selumetinib can induce sustained tumor volume decreases in adults with inoperable PNs and is well tolerated, while paired biopsies reveal novel pharmacodynamic insights. Kinase enrichment proteomic analysis was performed using patient pre-treatment/baseline and on-treatment specimens when sufficient material was obtained, with detectable on-target loss of binding of selumetinib targets MEK2 and MEK1 in treated samples.
2024-09-12 | PXD043034 | Pride
Project description:The aim of this Phase 2, two-arm, randomized, double blind placebo controlled study is to evaluate the efficacy of combination therapy of doxycycline and Vitamin K1 compared to doxycycline plus placebo for the prevention of acne-like skin rash in mCRC patients receiving first line cetuximab treatment.
| 2106044 | ecrin-mdr-crc
Project description:The purpose of this study is to see if the investigators can prevent or reduce the severity of the Cetuximab-related acne rash. Two different topical agents will be applied to the skin. One topical agent is the dapsone gel and the other is a skin moisturizer. Dapsone gel is an FDA approved medication that you apply to the face. It is commonly used to treat acne. Skin moisturizers are recommended to patients who receive Cetuximab treatment. In addition to these topical agents they will be given a pill to take once a day. This pill has already been shown to help fight rashes from Cetuximab.
| 2150735 | ecrin-mdr-crc
Project description:Importance:Photoaging, which is premature skin aging caused by long-term UV exposure, is of aesthetic concern to many patients. Objective:To investigate the effect of topical fluorouracil, 5%, cream on photoaging using validated photonumeric scales. Design, Setting, and Participants:The Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial was a randomized clinical trial of 932 US veterans with a recent history of 2 or more keratinocyte carcinomas performed from September 30, 2011, through June 30, 2014, to assess the chemopreventive effects of a standard course of topical fluorouracil. Photographs were taken at baseline and at numerous time points for up to 4 years. In our secondary analysis, 2 independent dermatologists graded these photographs using 4 validated photonumeric scales. A total of 3042 photographs from 281 participants randomized to apply topical fluorouracil or placebo were evaluated at baseline, 6 months, 12 months, and 18 months using 4 photonumeric scales (Griffiths scale, Allergan forehead lines scale, melomental folds scale, and crow's feet scale). Data analysis was performed from November 1, 2016, to January 1, 2017. Interventions:Participants were randomized to apply topical fluorouracil, 5%, cream or a vehicle control cream to the face and ears twice daily for 2 to 4 weeks for a total of 28 to 56 doses. Main Outcomes and Measures:Effect of a standard course of fluorouracil on the extent of photodamage as measured using 4 photonumeric scales. Results:The study population was predominantly male (274 [97.5%]) and white (281 [100%]), with a mean (SD) age of 71.5 (0.57) years. No statistically significant changes were found in photodamage between baseline and 6 months (Griffiths scale: ?2?=?0.01, P?=?.93; Allergan forehead lines scale: ?2?=?0.18, P?=?.67; melomental fold scale: ?2?=?0.03, P?=?.87; crow's feet scale: ?2?=?2.41, P?=?.12), 12 months (Griffiths scale: ?2?=?1.39, P?=?.24; Allergan forehead lines scale: ?2?=?0.64, P?=?.43; melomental fold scale: ?2?=?0.12, P?=?.73; crow's feet scale: ?2?=?1.07, P?=?.30), and 18 months (Griffiths scale: ?2?=?3.11, P?=?.08; Allergan forehead lines scale: ?2?=?0.89, P?=?.34; melomental fold scale: ?2?=?1.64, P?=?.20; crow's feet scale: ?2?=?0.46, P?=?.50). Conclusions and Relevance:This study did not demonstrate improvement in photoaging with a standard course of topical fluorouracil, 5%, cream, a finding that may be attributable to a true lack of effect in photodamage or limitations of the photonumeric scales in capturing the effect. The development of photonumeric scales that include manifestations of photoaging other than rhytids, such as lentigines, hyperpigmentation, and telangiectasias, should be considered. Trial Registration:clinicaltrials.gov Identifier: NCT00847912.
| S-EPMC5710428 | biostudies-literature
Project description:In order to investigate the early pathological alteration of EGFRI-induced rash, we treated rat with vehicle or afatinib for 3 days. We then performed gene expression profiling analysis using data obtained from RNA-Seq of 3 different rat skins in each group
2024-05-20 | GSE201504 | GEO
Project description:Little is known whether topical analgesic creams, whose natural products enter the blood stream after application, affect myocardial infarct size. Here we tested whether topical analgesic creams can trigger remote cardioprotection and the mechanism involved. Male Sprague Dawley rats were used for an in vivo rodent model consisting of 30 minutes left anterior descending coronary artery ischemia and 2 hours of reperfusion followed by infarct size assessment. The topical analgesic IcyHot, applied to the abdomen prior to ischemia, reduced myocardial infarct size versus control (41 ± 3* vs 62 ± 1, n= 6/group, *P < 0.001). In contrast, the topical analgesic creams Preparation H, Aspercreme Heat, or Tiger Balm did not alter infarct size. IcyHot, unlike Preparation H, increased circulating methyl salicylate levels during reperfusion (3.0 ± 0.6 vs 0.4 ± 0.2 mg/dL, n = 6, *P < 0.001, measured at the internal jugular vein). Methyl salicylate (10 μM) applied to isolated adult cardiac myocytes during reoxygenation reduced cell death when compared to vehicle (21% ± 2%* vs 30% ± 2% of trypan blue positive cells, n = 9/group, *P < 0.01). Further, treatment with the TRP ankyrin 1 (TRPA1) inhibitors TCS-5861528 (1 μM) or AP-18 (1 μM) blocked the methyl salicylate-induced protective effect in isolated adult cardiomyocytes. In intact rodents, either of the TRPA1 inhibitors (1 mg/kg, intravenous) given prior to IcyHot topical application blocked IcyHot-induced infarct size reduction. IcyHot also reduced infarct size when applied 24 hours prior to myocardial ischemia or during myocardial ischemia versus control. Together, these findings support IcyHot analgesic cream can trigger remote cardioprotection through releasing methyl salicylate into the bloodstream with cardioprotection occurring by a TRPA1-dependent mechanism.
| S-EPMC7719099 | biostudies-literature
Project description:Skin mRNA profiles of wild-type (WT) and EGFR Inhibitors (Gefitinib and Afatinib) induced rash rats were generated by deep sequencing, in triplicate, using Illumina GAIIx. Raw sequences were mapped to the rat reference sequence by Hisat2 v2.0.5. FeatureCounts v1.5.0-p3 was used to count the reads numbers mapped to each gene. FPKM of each gene was calculated based on the length of the gene and reads count mapped to this gene. Differential expression analysis was performed using the DESeq2 R package (1.16.1).
2022-04-04 | GSE199970 | GEO