Browse
Submit Data
Databases
API
Help

Dataset Information

0 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Safety and Efficacy of Atuzabrutinib Topical Gel in Patients with Mild-to-Moderate Atopic Dermatitis: Findings from Phase 2a Trial

ABSTRACT: Safety and Efficacy of Atuzabrutinib Topical Gel in Patients with Mild-to-Moderate Atopic Dermatitis: Findings from Phase 2a Trial

PROVIDER: PRJNA1224777 | ENA |

REPOSITORIES: ENA

ACCESS DATA

Json Xml

Similar Datasets

Safety and Efficacy of Atuzabrutinib Topical Gel in Patients with Mild-to-Moderate Atopic Dermatitis: Findings from Phase 2a Trial

Project description:This phase 2a study of atuzabrutinib (PRN473/SAR444727), a Bruton tyrosine kinase inhibitor, comprised of a double-blind placebo-controlled treatment period and an open-label uncontrolled treatment period and evaluated safety and efficacy of atuzabrutinib 5% gel vs placebo (in double-blind period) in patients with mild-to-moderate atopic. dermatitis (AD). Patients aged 18–70 years diagnosed with mild-to-moderate AD (N=39) for at least 6 months were included in the study. During the double-blinded Period (Days 1–14), two target lesions with a difference ≤1 point in total sign score (TSS) were randomized 1:1 to atuzabrutinib or matching placebo twice daily. During open-label period (Days 15–42), patients continued to treat the assigned areas and other AD-affected lesions (except scalp, palms, soles and genitals) with atuzabrutinib BID. The objective is to evaluate the safety, tolerability, PK and preliminary efficacy of atuzabrutinib in patients with mild to moderate AD. RNA sequencing analysis was performed to understand the target immune cell expression in lesional skin biopsies versus normal skin and the effect of atuzabrutinib.

2025-03-01 | GSE289784 | GEO

A Phase 1b Randomized Single-Center Trial of Topical Cerdulatinib (DMVT-502) in Patients with Mild-to-Moderate Atopic Dermatitis

Project description:This phase 1b, single-center, double-blind study evaluated safety, efficacy, and effect on molecular profiles of a topical Janus kinase/spleen tyrosine kinase (JAK/Syk) inhibitor, cerdulatinib gel 0.37%, in ten adults with mild-to-moderate atopic dermatitis (AD).

2020-11-12 | GSE141570 | GEO

Bioadhesive black rasberry gel effect on gene expression and proinflammatory proteins in human premalignant oral lesions

2008-06-01 | GSE10174 | GEO

Study of Prophylactic Topical Dapsone 5% Gel Versus Moisturizer for Cetuximab-induced Papulopustular (Acneiform) Rash in Patients With mCRC or HNSCC Without Previous or Concurrent RT

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

Transcription profiling of human oral lesions treated with bioadhesive black rasberry gel to determine the effect on gene expression and proinflammatory proteins

Project description:This portion of the study evaluated the effects of topical 10% black raspberry gel application on gene expression profiles of premalignant oral lesions. Topical application of the bioadhesive black rasberry gel was observed to modulate gene expression and reduce proinflammatory proteins in human premalignant oral lesions. Experiment Overall Design: Each patient served as their own internal control. A pretreatment specimen of the premalignant lesion was obtained for baseline parameters. Following six weeks of treatment, the treated lesional tissue was removed. All tissue samples were immediately placed in RNA later and placed in a -80 degree freezer until sample preparation.

2008-06-18 | E-GEOD-10174 | biostudies-arrayexpress

A Phase 1b Randomized Single-Center Trial of Topical Cerdulatinib (DMVT-502) in Patients with Mild-to-Moderate Atopic Dermatitis

Project description:A Phase 1b Randomized Single-Center Trial of Topical Cerdulatinib (DMVT-502) in Patients with Mild-to-Moderate Atopic Dermatitis

| PRJNA593978 | ENA

A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel

Project description:Human immunodeficiency virus (HIV) disproportionately affects men who have sex with men (MSM) and transgender women (TGW). Safe and acceptable topical HIV prevention methods that target the rectum are needed. MTN-017 was a phase 2, 3-period, randomized sequence, open-label, expanded safety and acceptability crossover study comparing rectally applied reduced-glycerin (RG) 1% tenofovir (TFV) and oral emtricitabine/TFV disoproxil fumarate (FTC/TDF). In each 8-week study period participants were randomized to RG-TFV rectal gel daily, or RG-TFV rectal gel before and after receptive anal intercourse (RAI; or at least twice weekly in the event of no RAI), or daily oral FTC/TDF. MSM and TGW (n = 195) were enrolled from 8 sites in the United States, Thailand, Peru, and South Africa with mean age of 31.1 years (range 18-64). The clinical results were reported here https://www.ncbi.nlm.nih.gov/pubmed/27986684. For the gene expression study, rectal biopsies were obtained from a subset of participants (n = 36) in the United States (Pittsburgh) and Thailand (Bangkok). Biopsies were provided at baseline and after each study period.

2020-07-07 | GSE138723 | GEO

Results of the phase 1, randomized, placebo-controlled first-in-human trial of griffithsin formulated in a carrageenan vaginal gel

Project description:Griffithsin (GRFT) is an anti-viral lectin with potent anti-HIV activity. GRFT’s preclinical safety, lack of systemic absorption after topical administration, and lack of cross-resistance with existing products prompted its development for topical HIV pre-exposure prophylaxis. We evaluated safety, pharmacokinetics and pharmacodynamics of PC-6500 (0.1% GRFT in a carrageenan (CG) gel) in healthy, HIV-negative, non-pregnant women following once daily vaginal gel administration for 14 days. No significant adverse events, histopathological changes in cervico-vaginal mucosa, or anti-drug (GRFT) antibodies were detected. No cervicovaginal proinflammatory responses and no changes in the ectocervical transcriptome were evident. Vaginal microbiome remained largely unchanged. Reduced abundance of vaginosis-associated bacteria and decreased levels of proinflammatory chemokines (CXCL8 and CCL20) were observed. GRFT was not detected in plasma. GRFT and GRFT/CG in CVLs dose-dependently inhibited HIV and HPV, respectively, in vitro. The data suggest GRFT/CG is a promising on-demand multipurpose prevention product that warrants further investigation.

2021-10-04 | GSE141478 | GEO

Topical application of temperature sensitive gel containing caerin 1.1 and 1.9 peptides on TC-1 tumour bearing mice modulates heterogeneity of macrophage and dendritic cell in the tumour microenvironment

Project description:In this study, we demonstrate that, the topical application of a temperature-sensitive gel containing caerin 1.1 and 1.9 peptides significantly reduces the tumour weight of HPV 16 E6/E7 transformed TC-1 tumour bearing mice via improving the tumour microenvironment (TME) when compared with untreated tumour or a control peptide-containing gel. We use single cell transcriptomics and TMT10 plex-labelling proteomics to quantify changes in cellular activity across different cell types within the TME. We show that caerin 1.1/1.9 gel increased immune activating macrophages, modulated the heterogeneity of NK and dendritic cells to be more pro-inflammatory, and increased numbers of activated CD8+ T cells. Proteomic profiling demonstrated higher innate immune responses, especially the positive regulations of interferon-alpha/beta secretion and response to cytokine stimulus in the caerin gel groups. Further, computational integration of the proteome with the single cell transcriptome consistently suggested more activated T cells and NK cells with the treatment of caerin peptide gel.

2022-02-17 | PXD025779 | Pride

Mucosal effects of tenofovir 1% gel wane over longer-term use but retain pro-proliferative and type I/III interferon pathway signatures [MTN014_15cmRectum]

Project description:The nucleotide reverse transcriptase inhibitor (NRTI) tenofovir has been extensively tested as a topical preventative against vaginal and rectal HIV transmission. We sought to determine how use of this product affects gene expression. We used samples from MTN-014, a study of vaginal and rectal gel application. We obtained rectal biopsies before treatment initiation and after two weeks of daily use of tenofovir 1% gel applied rectally or vaginally. We isolated RNA from rectal biopsies preserved with RNAlater. Gene expression was measured from all three samples (three time points) from each participant.

2025-06-02 | GSE277355 | GEO

OmicsDI is part of the ELIXIR infrastructure

OmicsDI is an Elixir interoperability service. Learn more ›

Tweets

OmicsDI Databases

PRIDE
PeptideAtlas
MassIVE
JPOST Repository
Physiome Model Repository

EGA
EVA
ENA
LINCS
PAXDB
Cell Collective

MetaboLights
Metabolomics Workbench
MetabolomeExpress
GNPS
BioModels
FAIRDOMHub

ArrayExpress
dbGaP
ExpressionAtlas
GEO
NODE

Information

Databases
Help
API
Contact us
Code on GitHub
Terms of use
Submit Data