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Dermatitis clinical trials

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NCT ID: NCT05948306 Enrolling by invitation - Pressure Injury Clinical Trials

Effects of Critical Patient-centered Skin Care Protocol

Start date: September 27, 2023
Phase: N/A
Study type: Interventional

Many critical diseases can damage skin and tissue integrity due to natural immobility, hemodynamic instability, poor tissue perfusion, use of medical devices and many other internal and external factors. Skin damage frequently seen in intensive care units; It can be listed as skin tears and secondary cutaneous infections, especially pressure injuries (PI) and incontinence-associated dermatitis (IAD). In the DecubICU's study, which has the largest sample number ever, published in 2021, the prevalence of pressure ulcers and related factors in 1117 intensive care units from 90 different countries were evaluated; Pressure ulcers were detected in 6747 of 13,254 patients hospitalized in the ICU, and 57% of these wounds were reported to be associated with the intensive care unit. In addition to pressure injuries, another skin problem that has also been focused on in nursing science in the last 10 years; incontinence-associated dermatitis. IAD, which develops on the skin exposed to urine and faeces, is not only a skin damage that needs to be examined on its own, but also paves the way for the development of pressure sores and can also progress together with pressure injuries. The study which was published in 2018, examined 109 intensive care patients, while the incidence of IAD was determined as 23.6%, while in 2019 another study in which 351 patients were included for 52 weeks, annual prevalence of IAD ranged from 17% and weekly incidences ranged from 0-70%. The findings of three different studies conducted in the intensive care unit are that IAD developed in 6% of 112 patients, 26.2% of 145 patients, and 65.4% of 266 patients, respectively. However, despite the limited literature, the high prevalence rates and the strong relationship between pressure injuries and incontinence associated dermatitis point to the necessity of evaluating these two skin injuries together. Each existing skin injury reduces the quality of life by causing pain and pain to the individual, and also increases hospitalizations and infection rates, placing a financial burden on the health system and causing loss of workforce. For all these reasons, skin problems are considered as a quality indicator in hospitals and the primary responsibility for maintaining skin integrity is attributed to nurses. Guidelines published by EPUAP, National Pressure Injury Advisory Panel and Pan Pacific Pressure Injury Alliance (PPPIA) in 2019 in the prevention of pressure injuries in intensive care units play a key role in determining nurses' attempts to preserve skin and tissue integrity. In the prevention of incontinence-related dermatitis, the best practices guide published by Dimitri Beckmann in 2015 should be integrated into clinics. Furthermore, the person-centered approach in skin care has been considered as a concept that should be focused on by the authors in recent years, and in a systematic review published in 2020, clinical applications of the person-centered care approach in wound care were suggested by considering the current evidence. However, the resources in which prevention strategies are focused on individual-centered care are very limited. Therefore, in this study, it was aimed to develop a critical patient-centered skin care protocol and to examine the effects of this protocol on the barrier functions of the skin. HYPOTHESES AND DETAILED AIMS ARE BELOW. The primary aim of the study is to examine the effect of critical patient centered skin care on the barrier function of the skin. The hypotheses for the primary purpose of this study are as follows: H0: Application of critical patient-centered skin care protocol has no effect on skin barrier function (skin temperature, transepidermal water loss, skin pH, and secondary infection). H1: Application of critical patient-centered skin care protocol has an effect on the barrier function of the skin (skin temperature, transepidermal water loss, skin pH, and secondary infection). The secondary aim of the study is to examine the effects critical patient-centered skin care on the incidence and development time of incontinence-associated dermatitis and pressure injuries. In this direction, the hypotheses for the secondary purpose of this study are as follows: H0: Application of critical patient-centered skin care protocol has no effect on the incidence of incontinence associated dermatitis and the incidence of pressure injury and their development times. H1: Application of critical patient-centered skin care protocol has an effect on the incidence of incontinence associated dermatitis and the incidence of pressure injury and their development times.

NCT ID: NCT05945810 Completed - Atopic Dermatitis Clinical Trials

Evaluation of TLL-018 Extended and Immediate Release Formulation for Bioequivalence Testing in Healthy Chinese Subjects

Start date: July 12, 2023
Phase: Phase 1
Study type: Interventional

The goal of this two-sequence, two-cycle, single and multiple-dose Phase I clinical trial is To evaluate the human bioequivalence of the test preparation and the reference preparation in 28 healthy chinese subjects at a single center.

NCT ID: NCT05942248 Recruiting - Acne Clinical Trials

The Use of Image-Based Computer Gradings in the Analysis of Acne, Rosacea, Melasma, and Seborrheic Dermatitis

Start date: June 6, 2023
Phase: N/A
Study type: Interventional

The study is conducted to determine if image-based computer grading can of acne, melasma, rosacea and seborrheic dermatitis correlate well to expert based clinical severity grading.

NCT ID: NCT05938478 Recruiting - Atopic Dermatitis Clinical Trials

Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT

PROTECT
Start date: December 8, 2022
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to learn about exposure to tralokinumab during pregnancy, as well as atopic dermatitis (AD) during pregnancy. The main question the study aims to answer is whether pregnant people who have been exposed to tralokinumab during pregnancy experience any differences in pregnancy and infant outcomes compared to women with atopic dermatitis who have not been exposed to tralokinumab during pregnancy. Participants are not required to take tralokinumab during the study. Participants will be asked to: - Complete 1-3 phone interviews during pregnancy and 1-2 phone interviews after delivery - Release medical records for pregnancy and for their child - Complete an online survey about their baby's development at 4 months and 12 months of age - May be asked to have a study doctor examine their child All information is collected remotely, and no visits to the study site are required.

NCT ID: NCT05935085 Recruiting - Clinical trials for Atopic Dermatitis Eczema

This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects With Moderate to Severe Atopic Dermatitis (AD).

Start date: June 13, 2023
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, and efficacy of ANB032 in subjects with moderate to severe atopic dermatitis (AD).

NCT ID: NCT05934422 Enrolling by invitation - Atopic Dermatitis Clinical Trials

NiPPeR Randomised Trial - Child Follow Up Study

NiPPeR Child
Start date: June 16, 2023
Phase: N/A
Study type: Interventional

There is an increasing focus on the need to optimise nutrition, lifestyle and metabolism of parents before and during pregnancy and of the infant after birth, but as yet there is limited understanding of the specific influences and of the underlying mechanisms. This study is a follow up of children from the NiPPeR trial of a nutritional drink enriched with micronutrients, myo-inositol and probiotics taken preconception and during pregnancy. In this setting we will examine the influence of parental nutrition, lifestyle and metabolism before and during pregnancy on child growth, development and well-being; ascertaining growth, adiposity, metabolism, neurobehavioural and health outcomes in the children, and characterising the underlying mechanisms. The data collected will allow identification of the contributions of parental and offspring characteristics, nutritional, lifestyle and medical factors, social and economic status, ethnicity, genetics, metabolism and microbes to promoting healthy growth, body composition and wellbeing in the children.

NCT ID: NCT05932888 Completed - Atopic Dermatitis Clinical Trials

Safety, Tolerability, and Pharmacokinetic Study of QLM3003 in Healthy Adult Subjects

Start date: June 25, 2023
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be evaluated.

NCT ID: NCT05932654 Recruiting - Atopic Dermatitis Clinical Trials

POC Study to Evaluate BSI-045B Monotherapy and BSI-045B add-on Therapy With Dupilumab in Atopic Dermatitis

ADAMANT
Start date: July 31, 2023
Phase: Phase 2
Study type: Interventional

The study is a multicenter clinical trial and is designed as a proof-of-concept study to evaluate the efficacy, safety, tolerability, PK, immunogenicity, and PD of BSI-045B following SC injections, as monotherapy or as add-on therapy with dupilumab. The study will enroll patients with moderate to severe AD in 4 cohorts. There will be 2 Monotherapy Cohorts, assigned to different doses of BSI-045B: a 300 mg Cohort and a 480 mg Cohort. There will be 2 Add-on Therapy Cohorts, assigned to different doses of BSI-045B: a 300 mg Cohort and a 480 mg Cohort. Patients in the Monotherapy Cohorts will be treated with BSI 045B. Patients in the Add-on Therapy Cohorts will be treated with BSI-045B, concomitantly with steady-state dupilumab treatment. Patients in each of these 4 cohorts will initially be treated with a loading dose of BSI-045B given every week (QW) for 3 weeks. Thereafter, BSI-045B will be administered every 2 weeks (Q2W) and patients will receive their assigned dose of BSI-045B (300 mg or 480 mg) Q2W through Week 24.

NCT ID: NCT05928169 Recruiting - Psoriasis Clinical Trials

Determinants of Chronic Inflammatory Skin Disease Trajectories

Start date: May 1, 2023
Phase:
Study type: Observational

Although it is well known that the clinical expression and course of chronic inflammatory skin diseases are highly variable, there are insufficient epidemiological data on this, and the factors that determine the manifestation, clinical features and course are also largely unknown. There are currently no reliable markers that could predict or delineate patient subgroups to support patient management. The aim of this project is to identify clinical and molecular factors that correlate with disease, disease subtypes and progression through in-depth long-term clinical characterization of patients with chronic inflammatory skin diseases and examination of individual biomaterials.

NCT ID: NCT05923099 Recruiting - Atopic Dermatitis Clinical Trials

A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis

Start date: September 20, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to test different doses of the trial medicine (LEO 138559) at treating moderate to severe atopic dermatitis in adults. There will be 4 different doses, that will also be compared to a placebo (a dummy medicine that doesn't contain the active ingredient of LEO 138559). Each participant will be randomly assigned to one of the 4 doses of LEO 138559 or placebo. In all arms, injections of placebo may be used to mask the different doses. The trial will last up to 36 weeks, including a screening/washout period (up to 4 weeks), a treatment period (16 weeks), and a follow up period (16 weeks). The participants will visit the clinic 17 times. For the first 4 weeks of the treatment period, participants will visit the clinic every week. For the next 12 weeks of the treatment period, participants will visit the clinic every 2 weeks. For the 16 week follow up period, participants will visit the clinic every 4 weeks. The treatments will be given to the participants by staff at the clinic. They are given as an injection just under the skin. At each visit the doctor will check the participants atopic dermatitis and if they have had any side effects. Participants will also complete an electronic diary every day about their atopic dermatitis and quality of life.