RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE
Breast CancerRadiation dermatitis is experienced by almost all patients (up to 95%) receiving radiation therapy for cancer. Radiation dermatitis can be a serious condition because, in addition to its direct physical complications and the resulting impact on overall quality of life, it can also be a dose-limiting toxicity requiring changes to the prescribed course of radiation therapy. The most common strategy employed in an attempt to prevent or minimize radiation dermatitis involves moisturization of the irradiated area, use of a mild soap to keep the area clean, and minimizing exposure to potential mechanical irritants, such as scratching and rough clothing. However, this strategy has been shown to lack clinically significant efficacy. Consequently, there is a clinical need for new treatments that are effective in protecting against radiotherapy-induced oxidative stress and the subsequent development of radiation dermatitis. Based on data from previous studies in animals and humans, Reata believes that omaveloxolone (RTA 408) Lotion may effectively prevent and mitigate radiation dermatitis in oncology patients undergoing radiation therapy. This randomized, double-blind, vehicle-controlled, parallel-group trial will study the efficacy, tolerability and safety of two concentrations of omaveloxolone (RTA 408) Lotion (3% and 0.5%) versus vehicle in patients with breast cancer for whom radiation therapy is recommended.
Examination of Whether Host Preconditioning Modifies Short-term Transplant Survival
Atopic DermatitisEczemaUnlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of S. aureus skin infections. In addition, research in the investigator's lab has shown that these patients have fewer protective antimicrobial Staphylococcal species such as Staphylococcal epidermidis (S. epidermidis) known to produce antimicrobial peptides that play a role in protecting the skin from invading pathogens. In this study, the investigator will attempt to decrease S. aureus colonization and increase colonization by protective Staph species. First the investigator will culture the bacteria on subjects' lesional AD skin. The investigator will selectively grow the subject's antimicrobial Staph colonies and place them into a base moisturizer. The moisturizer plus bacteria will be applied to both of the subject's arms. Prior to applying this, though, one arm will first be pre-treated with an antimicrobial regiment of Dial liquid antibacterial soap and alcohol. We will then compare the abundance of antimicrobial Staph species on each subject's arms 24 hours later to determine whether the pre-treatment regimen increased survival of the transplanted antimicrobial Staph species. The investigator expects that the arm pre-treated with the antimicrobial regimen will have more antimicrobial Staph species at this time point.
Chronic Hand Eczema - Self-management and Prognosis
Chronic Hand EczemaChronic Hand DermatitisHand eczema is a common disease which often gives a chronic course thus affecting many functions in daily life. The body of evidence related to self-management of chronic hand eczema is poor. Better methods to support self-management of patients with chronic hand eczema may potentially improve the prognosis of a disease which is both a tremendous burden to the individual and to the society. The purpose of this trial is to evaluate the effect of a newly designed guidance programme offering individual counselling compared to conventional information with written information sheets.
Management of Eczema by Specific Probiotic Strains
EczemaAtopic DermatitisTo investigate the therapeutic effect of a selected probiotic mixture on the severity of AD in infants aged 0-15 months. The probiotic mixture has been studied in laboratory setting and has proven IL-10 stimulating effects. Therefore it is thought to decrease AD severity in young children (beyond the conventional treatment).
Trial Comparing Best Supportive Care to Aloe Vera Gel
Radiation DermatitisRadiation therapy (RT) has been a component of breast cancer treatment for almost 100 years. Although initially used for the treatment of chest wall recurrences after mastectomy and for advanced inoperable disease, RT has evolved into a critical component of early therapy for women with an intact breast following lumpectomy and for mastectomized women who are at high risk for local failure. Currently breast cancer patients need a multidisciplinary management including surgery, chemotherapy and radiotherapy, radiotherapy has a significant role in loco regional control of the disease. It is estimated that 87% of these women will develop some degree of radiation-induced dermatitis, varying from mild to brisk erythema or even moist desquamation. Topical agents, such as corticosteroid creams and other products including Aquaphor (Beirsdorf Inc, Wilton, CT), and trolamine (Biafine; Genmedix Ltd, France), are commonly prescribed at the onset of radiation dermatitis or, in some institutions, at the beginning of radiotherapy. The aim of this randomized phase III study was to assess the effectiveness of aloe vera cream for the prevention of acute radiation-induced dermatitis of grade 2 or higher during postoperative radiotherapy for breast cancer, compared to best supportive care. The secondary objectives were to assess pain, treatment interruption as a result of skin reactions, and the quantity of life during the treatment.
A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects...
Atopic DermatitisThe purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.
Clinical Evaluation of Bacitracin
Allergic Contact DermatitisThe purpose of this study is to establish a concentration of a bacitracin-patch for diagnosing allergic contact dermatitis.
Comparison of JW-100 and EUCRISA for the Treatment of Atopic Dermatitis
Atopic DermatitisTo compare the efficacy of a JW-100 cream with active control (commercially available as EUCRISA®, Pfizer) for the treatment of atopic dermatitis (AD) in adult patients with mild to moderate AD measured with the Investigator's Static Global Assessment (ISGA) scale.
Laser Therapy for Perioral Dermatitis
Perioral DermatitisPerioral dermatitis is an inflammation of the skin around the mouth. The cause of perioral dermatitis is unknown. Current treatment methods include oral antibiotics and topical calcenurin inhibitors, both of which produce side effects and have been relatively ineffective in the treatment of perioral dermatitis. The investigators hope to assess the efficacy of laser therapy in treatment of perioral dermatitis by using laser therapy on one half of the patients face and having patients apply topical medication (clindamycin) to their face for 8 weeks. The side of their face that receives laser therapy will be randomized. The investigators will assess the efficacy of laser therapy by counting the number of lesions that patients have before and after laser therapy, comparing photos of patient's perioral dermatitis before and after treatment, and having patient's rate their satisfaction of the treatment.
Tencel vs. Standard Cotton Therapeutic Garments as an Adjunct Treatment for Moderate to Severe Atopic...
Atopic DermatitisApproximately 15-20% of children in the United States suffer from the symptoms of atopic dermatitis (eczema), which include pruritus, pain, irritation, and difficulty sleeping. Tencel fabric has been marketed as a superior fabric for children with atopic dermatitis due to improved moisture absorption and decreased bacterial growth compared to cotton and synthetic fabrics. However, no dermatologic studies have been conducted on Tencel fabric. The investigators' objective is to perform a randomized double-blinded trial comparing Tencel garments to traditional cotton for children with moderate to severe atopic dermatitis. The investigators hypothesize that children in the Tencel group will demonstrate improvement in Eczema Area and Severity Index (EASI) scores, Investigator's Global Assessment, pruritus as measured by ItchyQoL: A Pruritus-Specific Quality of Life Instrument, and Children's Dermatology Life Quality Index (CDQLI) or Infant's Dermatitis Quality of Life Index (IDQoL). An randomized double-blind trial of 12 weeks duration will be conducted. Fifty children age 6 months to 6 years with moderate to severe eczema will be recruited from the Johns Hopkins pediatric dermatology clinic and given 6 weeks of standard skin directed therapy followed by 6 weeks during which children will be randomized to treatment with Tencel vs. cotton therapeutic garments in addition to standard eczema care. The primary outcome will be eczema severity as assessed by EASI score by blinded and trained investigators. Secondary outcomes will include patient-reported eczema symptoms (assessed through quality of life and pruritus scales, CDQLI or IDQoL and ItchyQoL scores) and frequency of infection of eczema lesions. Adherence with wearing study garments and usage of standard eczema treatments (topical corticosteroids and calcineurin inhibitors, emollients, and wet/dry wraps) will also be assessed.