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Dermatitis clinical trials

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NCT ID: NCT05594498 Active, not recruiting - Breast Cancer Clinical Trials

A Study of StrataXRT in the Prevention of Radiation Dermatitis in Breast Cancer Patients

Start date: October 13, 2022
Phase: N/A
Study type: Interventional

For breast cancer patients undergoing adjuvant radiotherapy, radiation dermatitis (RD) is a common occurrence that can negatively impact patients' quality of life (QOL). RD often presents as erythema, pruritus, and/or edema and in more severe cases, skin breakage can occur, resulting in moist desquamation. StrataXRT is a silicone-based film-forming topical gel. Recent studies have shown the benefits of StrataXRT, but with mixed results. A recent randomized controlled trial published in 2022 found that in breast cancer patients (n=100), the use of StrataXRT significantly reduced the mean size of the radiation-induced dermatitis area (p=0.002) when compared to the control group. Additionally, another study (n=49) demonstrated significant differences in the Erythema Index (EI) (p=0.001) and Melanin Index (MI) (p=0.005) between StrataXRT compared to the use of Xderm, a moisturizer cream. To validate the finding of the previous studies a pilot study testing the efficacy of StrataXRT has been proposed. In this study, 50 patients will use Strata XRT on their breast/chest wall during radiation treatment. Their skin will be assessed throughout and post-treatment. Investigators hypothesize the severity of skin reactions will be less for patients using Strata XRT when compared to historical data from our centre.

NCT ID: NCT05590585 Active, not recruiting - Atopic Eczema Clinical Trials

Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial

DISCOVER
Start date: January 11, 2023
Phase: Phase 4
Study type: Interventional

The study is focused on skin of color participants who have moderate-to-severe atopic dermatitis. Atopic dermatitis, also referred to as eczema, is a condition that causes the skin to become itchy, dry, and cracked. From the previous studies on the study drug, it is seen that the study drug has an acceptable safety and effectiveness in participants with atopic dermatitis. The aim of this study is to get additional information on the safety and effectiveness of the study drug, particularly the information on aspects of atopic dermatitis in skin of color participants. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in your blood at different times - How much the study drug improves quality of life and mental health

NCT ID: NCT05571943 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis

Start date: September 15, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label study to evaluate the long-term safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate AD. The study will also evaluate the long-term efficacy of difamilast ointment 1%, including durability of response.

NCT ID: NCT05517850 Active, not recruiting - Atopic Dermatitis Clinical Trials

Therapist-guided vs Self-guided CBT for AD: Non-inferiority Trial

Start date: November 29, 2022
Phase: N/A
Study type: Interventional

The study aims to test the hypothesized non-inferiority of a self-guided digital intervention compared to a therapist-guided variant for people with atopic dermatitis (AD). Both interventions are based on Cognitive behavioral therapy. Participants will be recruited from advertisements in social media. Measurements of AD symptoms and psychological well-being will be conducted at pre-treatment, post-treatment as well as 6-month and one-year follow-up.

NCT ID: NCT05507580 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis

Flex-Up
Start date: May 12, 2023
Phase: Phase 4
Study type: Interventional

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study evaluates the dosing flexibility of upadacitinib in adult participants with moderate to severe AD. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for the treatment of moderate to severe/active immune-mediated inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis (UC), Crohn's Disease (CD), and AD. The study is comprised of a 35-day Screening Period, a 12-week double-blind period and a 12-week single-blind period. During the double-blind period, participants are placed in 1 of 2 groups, called treatment arms and will be randomized in a 1:1 ratio to receive upadacitinib. At 12 weeks during the single blind period, participants will be blinded to the upadacitinib dose based on their EASI response and reassigned to in 1 of 4 arms. After the last study visit, there is a 30-day follow-up visit. Approximately 454 adult participants ages 18 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 160 sites worldwide. The study is comprised of a 12-week double-blind period, followed by a 12-week single-blind period. Participants will receive upadacitinib oral tablets once daily for up to 24 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05469464 Active, not recruiting - Atopic Dermatitis Clinical Trials

Study to Assess the Efficacy and Safety of Orismilast in Atopic Dermatitis (ADESOS)

Start date: July 11, 2022
Phase: Phase 2
Study type: Interventional

This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe atopic dermatitis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe atopic dermatitis and assess the safety aspects of these 3 different doses. The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.

NCT ID: NCT05466877 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study of MG-K10 in Subjects With Atopic Dermatitis

Start date: August 31, 2022
Phase: Phase 2
Study type: Interventional

This study evaluates the preliminary efficacy of MG-K10 in subjects with moderate to severe asthma, and provides a basis for the design and dosing regimen of phase III clinical trials.

NCT ID: NCT05456529 Active, not recruiting - Clinical trials for Atopic Dermatitis (AD)

Study of Ruxolitinib Cream in Adolescents With Atopic Dermatitis

Start date: September 1, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability of ruxolitinib cream in adolescents with Atopic Dermatitis (AD).

NCT ID: NCT05442645 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study in Male and Female Adult Patients With Atopic Dermatitis Treated With Dupilumab in Taiwan

Start date: July 20, 2022
Phase:
Study type: Observational [Patient Registry]

Primary objective: To characterize the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment for adult AD patients, who are eligible for dupilumab reimbursement in Taiwan (e.g., used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching). Secondary objectives: - To characterize the adult AD patients, who are eligible for dupilumab reimbursement in Taiwan, with respect to their a) medical history, b) socio-demographic, c) disease characteristics, d) comorbid with type 2 diseases [e.g., Asthma, Chronic rhinosinusitis with nasal polyp (CRSwNP)], and e) prior and concomitant treatments of atopic dermatitis - To assess the effectiveness and safety of dupilumab in adult atopic dermatitis patients, who are eligible for dupilumab reimbursement in Taiwan - To assess comorbid atopic conditions and effects of dupilumab treatment for comorbid atopic conditions in adult patients, who are eligible for dupilumab reimbursement in Taiwan - To evaluate the correlation of patient reported outcome [Atopic Dermatitis Control Tool (ADCT)] and physician assessment [Eczema Area and Severity Index (EASI)] from the recruited subjects

NCT ID: NCT05398445 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

ROCKET-Ignite
Start date: May 31, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.