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Blister clinical trials

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NCT ID: NCT06266195 Recruiting - Vesicle Clinical Trials

Spectroscopic Profiling of Extracellular Vesicles By Resonant Gold Nanostructures in the Infrared

PROVEIR_1
Start date: March 15, 2023
Phase:
Study type: Observational [Patient Registry]

Extracellular vesicles, due to their ease of extraction and ability to represent the cells from which they originate, have high potential in the field of personalized medicine, especially in the identification of new early bio-markers of cancer, including hepatocellular carcinoma. Nevertheless, the development of high-throughput diagnostic methods in this area is still in its infancy, and the design of new integrated technological solutions is of great interest and topicality. The main hypothesis of this study is that the development of a novel technology integrating resonant gold nanostructures in the mid-infrared can significantly contribute to the development of new approaches for the diagnosis of hepatocellular carcinoma.

NCT ID: NCT05397834 Active, not recruiting - Asthma Clinical Trials

A Bioequivalence Study Between Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 250 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions

Start date: May 11, 2022
Phase: Phase 1
Study type: Interventional

Bioequivalence study between two inhaler products of ffluticasone propionate inhalation powder

NCT ID: NCT05378997 Completed - Clinical trials for Epidermolysis Bullosa

Safety, Tolerability, and Pharmacokinetics of Ascending Topical Doses of TCP-25 Applied to Epidermal Suction Blister Wounds, Non-Healing Leg Ulcers and Patients With Dystrophic Epidermolysis Bullosa.

Start date: April 7, 2022
Phase: Phase 1
Study type: Interventional

This is a three-part, Phase I, first-in-human study designed to evaluate the safety, tolerability, and potential systemic exposure of multiple topical doses of TCP-25. Part I includes healthy volunteers with acute epidermal wounds formed by the suction blister technique. Part II includes patients with non-healing leg ulcers and Part III patients with dystrophic epidermolysis bullosa (DEB).

NCT ID: NCT05311033 Recruiting - Skin Pigmentation Clinical Trials

Evaluation of a Tranexamoc Acid Treatment on Post-inflammatory Pigmentation in the Suction Blister Model

TRANEX
Start date: January 4, 2023
Phase: N/A
Study type: Interventional

Post-inflammatory hyperpigmentation (PIH) is a common sequela of inflammatory dermatoses. PIH results from the overproduction of melanin or irregular pigment dispersion after skin inflammation. The investigators have developed, validated and published an in vivo model of PIH based on an initial lesion involving suction blisters. In this study, they have demonstrated that the suction blisters model is able to reproduce an epidermal lesion and inflammatory state that, in melanin competent subjects, leads to consistent hyperpigmentation during real sunlight exposure without the need for additional artificial exposure to intense UV light. An increase in vascularisation is demonstrated by histology in early forms of PIH. The investigators have also shown this increase in vascularisation in their PIH model. Furthermore, the transcriptomic study in this model shows that UVA and visible light directly stimulate endothelial cells and increase angiogenesis but act essentially indirectly through the production by fibroblasts of uPA (urokinase-type plasminogen activator), a key factor in the modulation of extracellular matrices, inflammatory processes and angiogenesis. UPA is a serine protease that converts plasminogen to plasmin which promotes angiogenesis. Tranexamic acid (TA) is an antifibrinolytic that reversibly binds to plasminogen, preventing its conversion to plasmin and subsequent fibrin degradation. The aim of the study will be to evaluate the efficacy of tranexamic acid in preventing post-inflammatory hyperpigmentation induced in the suction blisters model in at-risk subjects.

NCT ID: NCT05086640 Recruiting - Sport Injury Clinical Trials

Evaluation of the Effectiveness of the Local Application of Lemon in the Prevention of Blisters in Ultra-trail Runners

BS-2
Start date: July 30, 2021
Phase: N/A
Study type: Interventional

For more than a decade, worldwide participation in ultra-marathons and ultra-trails (running races longer than the 42.195 km marathon) has been increasing. Although considered benign, blisters are a common problem, with serious consequences and limiting performance. Although blisters are a major factor limiting endurance performance, they are a reason for only 5.8% of ultra-trail runners to quit. While equipment is improving and participants are increasing and intensifying their training, there is no consensus on the prevention of blisters in ultra-trail running, even though it is the number one factor limiting sports performance. There are few prospective interventional studies on the prevention of blisters during outdoor activities. On many running forums, there is the hypothesis that lemon applied to the feet prevents the appearance of blisters. This hypothesis has never been scientifically studied. The investigators hypothesize that the local application of Lemon allows a reduction in the number of blisters on ultra-trail. The objective of this Blisters-stop 2 study is to evaluate the efficacy of local application of Lemon in preventing the appearance of blisters.

NCT ID: NCT05071651 Recruiting - Sport Injury Clinical Trials

Epidemiological Characteristics and Prevention Methods of Blisters in Ultra-trail Runners

Start date: April 6, 2021
Phase:
Study type: Observational [Patient Registry]

PRIMARY OBJECTIVE : To evaluate the methods of prevention of the appearance of blisters set up by the runners before and during an ultra-trail SECONDARY OBJECTIVES : To evaluate : - The main locations of blisters. - The severity of blisters - The effectiveness of prevention methods To evaluate the incidence of blisters in an ultra-trail context.

NCT ID: NCT05021887 Recruiting - Asthma Clinical Trials

A Bioequivalence Study Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions

Start date: August 13, 2021
Phase: Phase 1
Study type: Interventional

Bioequivalence study between two inhaler products of ffluticasone propionate inhalation powder

NCT ID: NCT04665895 Completed - Asthma Clinical Trials

A Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100mcg/Blister Oral Inhalation Powder/GSK in Patients With Asthma

ANASSA-PD
Start date: December 9, 2020
Phase: Phase 3
Study type: Interventional

Τherapeutic equivalence, randomized, multiple-dose, placebo-controlled, observer-blind, parallel group design consisting of a 2-week run-in period followed by a 4-week treatment period with Fluticasone propionate 100 mcg/ blister oral inhalation powder/Respirent Pharmaceuticals (Test) or FLOVENT DISKUS® 100mcg blister oral inhalation powder (Reference) or placebo.

NCT ID: NCT04308889 Completed - Inflammation; Skin Clinical Trials

Pro-Resolving Mediators in Acute Inflammation in Humans

Start date: July 2, 2018
Phase: Early Phase 1
Study type: Interventional

The investigators are undertaking a clinical blister model with or without dietary supplementation with omega-3 fatty acids (i.e., Lovaza) to determine the role of specialized pro-resolving mediators - endogenous lipids converted from omega-3 fatty acid precursors including those in Lovaza - on inflammation parameters and their resolution.

NCT ID: NCT04298398 Not yet recruiting - Cancer Clinical Trials

Impact of Group Psychological Interventions on Extracellular Vesicles in People Who Had Cancer

MindGAP-P
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Background: There is some evidence demonstrating the effect of psychological interventions in improvements in health biological parameters. To best of our knowledge, no study had addressed the impact of any psychological intervention on extracellular vesicles. In addition, Mindfulness-Based Cognitive Therapy (MBCT) and Emotion Focused Therapy for Cancer Recovery (EFT-CR) in the group have never been explored regarding extracellular vesicles and the effectiveness of these was not compared yet. Objectives: 1. To explore and compare the effect of MBCT and EFT-CR on biological parameters and psychological variables in distressed people who have had breast, prostate and colorectal cancer; 2. In addition, we will explore the acceptability through recruitment and retention rates of MBCT and EFT-CR in group and evaluate whether these interventions are appropriate for a larger clinical trial. Methods: The design of this study is a parallel randomized controlled trial. Participants will be randomized into MBCT, EFT-CR or usual care. Outcome measures will be assessed before, at the end of the intervention (8 weeks) and follow-ups (24 and 52 weeks from the baseline moment). Hypotheses: The researchers expected that both interventions will have an effect on extracellular vesicles and other study biomarkers as well as improvements in psychological outcomes, compared to treatment as usual (TAU) group. Regarding the comparative effectiveness, we did not have evidence to hypothesize which one of the interventions will be superior in both biological (extracellular vesicles) and psychological outcomes. Contribution for practice: The results of this preliminary study would permit to know if there are benefits of these psychological interventions on changes in extracellular vesicles and on psychological outcomes related to health. In addition, this study will permit to determine the acceptability of conducting a larger randomized controlled trial.