Randomized Phase III Trial With Mepitel Film for the Prophylaxis of Radiation Dermatitis in Breast...
Breast CancerRadiation DermatitisBreast cancer patients undergoing adjuvant radiotherapy commonly experience radiation-induced skin reactions which adversely impact quality of life. Importantly, patients receiving chest wall radiation or patients with large breasts are more likely to have worse skin reactions. In the last decade, there have been no significant advances in preventing or treating radiation-induced skin toxicities. In response to the lack of evidence, Sunnybrook investigators previously conducted a pilot study (REB #294-2018) of Mepitel Film and preliminary results showed improvements in high grade skin reactions. Mepitel Film has not been widely adopted in North America as more evidence is needed. The validate the efficacy of the film compared to the standard of care, a study testing the efficacy of the film is proposed. In the study, 216 patients will be randomized (2:1) to receive either the film or the institution's current skin treatments and all patients will have their skin assessed.
Can Vitamin D Treatment Help Treat Moderate to Severe Atopic Dermatitis in Young Children? The D-Vex...
Atopic DermatitisVitamin D is known to have a regulatory influence on both the immune system and skin barrier function. Studies in paediatric populations have found an inverse association of vitamin D levels and with both prevalence and severity of atopic dermatitis (AD). Trials of vitamin D as a treatment for AD are limited in number and size. There has never been a placebo-controlled randomised controlled trial of stoss high dose versus daily standard dose for the treatment of AD. Further, no trials have explored the presence of vitamin D pathway genes and response to treatment of AD. This pilot study will be used as a reference to determine outcomes and feasibility for undertaking a larger and more in depth definitive study.
Topical Steroids & Bacterial Decolonization for Radiation Dermatitis
Radiation DermatitisThe purpose of this study is to determine whether bacterial decolonization of the nares and skin, topical steroid therapy, or a combination of the two regimens prior to treatment with radiotherapy (RT) for breast and head and neck cancer patients can prevent grade 2 or higher grade radiation dermatitis (RD) graded via the Common Terminology Criteria for Adverse Events (CTCAE) scale and improve quality of life.
Clinical Relevance of Scratching and Sleep in Atopic Dermatitis
Atopic DermatitisAtopic Dermatitis (AD), otherwise known as (atopic) eczema, is a chronic relapsing inflammatory skin disease. For difficult-to-treat AD, treatment options are limited. A better understanding of the underlying immunological cause, led to development of new, targeted therapies. For evaluating effectiveness and making treatment decisions for these new therapies, only 2 subjective methods exist: 1. clinical scores (AD-severity scored by a physician using structured scoring system), 2. questionnaires (completed by AD-patients). Therefore, an objective AD-severity assessment method might provide benefits for clinical practice. In this study, it is evaluated whether scratching and sleep parameters, obtained with a smartwatch worn by AD-patients, provide added value for clinical practice in dermatology. The usability of this smartwatch system is evaluated by AD-patients.
Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel.
Radiation-induced DermatitisPrimary objective - To investigate the effectiveness of Jalosome® compared with placebo in the prevention and treatment of RID in patients with HNC undergoing RT. Secondary objectives: To investigate the effectiveness of Jalosome® in reducing the maximum severity of RID compared with placebo. To investigate the effect of Jalosome®, compared with placebo, on patients' quality of life. To investigate safety and tolerability of Jalosome®. To investigate patient's compliance to Jalosome® treatment. To investigate patient's global satisfaction with Jalosome® treatment.
Skin Care Strategies for Neonatal Jaundice Phototherapy to Prevent Atopic Dermatitis in Moderate...
Neonatal JaundiceAtopic DermatitisAtopic Dermatitis (AD) is a common chronic, recurrent, and inflammatory skin disease in children. The incidence of moderate to severe AD in infants aged 1-12 months in our country is as high as 25.41%, which is related to subsequent allergic diseases and affects Children's emotions and growth. There are limited drugs that can be used for infant AD. The current guidelines recommend early use of functional skin care products to prevent and treat AD by repairing the skin barrier, moisturizing, and anti-inflammatory. Neonatal jaundice is one of the most common neonatal diseases. 20% of children with jaundice need phototherapy. It is a simple and effective method for jaundice. Studies have found that phototherapy can convert Th2 to Th1, leading to an imbalance of pro-inflammatory and anti-inflammatory, which induces allergies. We speculate that it is of great value to take protective measures such as skin moisturizing during phototherapy for jaundice in children at high risk of allergies. This project intends to take the lead in conducting a randomized controlled study on the use of baby moisturizing products during neonatal phototherapy. Through evaluation projects such as skin microecology analysis, serum allergy indicators and AD clinical manifestations, it is verified that the use of functional skin care products in phototherapy of newborns with high allergies can delay and reduce the severity of AD in infants.
Long-Term Safety Follow-Up Study of SCM-AGH in Subjects Who Participated and Administered SCM-AGH...
DermatitisAtopicThis is a long-term safety follow-up study of the Phase I/II multicenter study of SCM-AGH in subjects with moderate to severe atopic dermatitis. subjects will be followed up for a maximum period of 240 weeks after the first dose of investigational product. Only subjects previously enrolled in protocol ADT2002 (ClinicalTrials.gov ID: NCT04179760) will be eligible for this long-term follow-up protocol.
Corrona Atopic Dermatitis Registry: A Study of Post Approval Drug Safety and Effectiveness
Atopic DermatitisThis prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for patients with atopic dermatitis under the care of a licensed dermatologist or qualified physician extender. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices. Condition or disease : Atopic Dermatitis
Background of Different Phenotypes of Coeliac Disease
Celiac DiseaseDermatitis HerpetiformisThe main purpose of this study is to investigate genetic, serological, immunological and microbiata diversities between different coeliac disease phenotypes and to discover applicable prognostic markers for specific phenotypes.
Identifying Atopic Dermatitis Patients at Risk for Developing Conjunctivitis During Dupilumab Treatment...
Atopic DermatitisStudy on ophthalmological comorbidities and the underlying pathomechanisms of conjunctivitis during dupilumab treatment in atopic dermatitis (AD) patients. Patients participate in the Bioday Registry.