This trial is evaluating whether tapinarof cream, 1% will improve 1 primary outcome and 4 secondary outcomes in patients with Eczema, Infantile. Measurement will happen over the course of Baseline to Week 8.
This trial requires 400 total participants across 2 different treatment groups
This trial involves 2 different treatments. Tapinarof Cream, 1% is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
"Eczema, infantile has a strong family history of more than 1 in 300 children. In our hospital, 85% with eczema, infantile required at least 1 corticosteroid therapy in order to resolve. Eczema, infantile should be included in the differential diagnosis of children with persistent rashes. The severity of eczema, infantile should be assessed as promptly as possible because of its close association with asthma. The condition is associated with recurrent infections. Effective treatment with immunostimulatory therapy may improve the prognostic result." - Anonymous Online Contributor
"Eczema is associated with a significant degree of symptomatology. The treatment of eczema is typically symptom based; topical corticosteroids are used to control itchiness and relieve discomfort. There are numerous topical and oral medications for psoriasis. Treatment for psoriasis is also symptom based and includes corticosteroids, topical and oral medications, and phototherapy. A systematic review from 2000 suggested that topical corticosteroids are efficacious in mild to moderate eczema. There is tentative evidence that immunosuppressant medications may provide a short-term reduction in flares. However, long-term treatment must be weighed up against the risks of side effects." - Anonymous Online Contributor
"This condition is typically diagnosed in infancy. It is important to note that the most common presenting symptoms are pruritic scaly eczema of childhood and atopic dermatitis in infancy. Other symptoms include abnormal scars, red eyes, and cough. Symptoms may worsen with hot or humid weather, stress, and fatigue. Those with eczema of infancy should use the PowerSite database to find clinical trials that are tailored to their condition." - Anonymous Online Contributor
"There appears to be a high incidence of the symptoms (worse in the early stages) of eczema in children with chronic eczema (that is not due to a physiological abnormality such as atopic dermatitis) and, in our hands at St Mark's Hospital, a high incidence of a family history of autoimmune disease. We have therefore been able to identify a child with eczema and an increased risk of autoantibodies, which is suggestive of autoimmune disease. We conclude that there is evidence that eczema in some children with chronic eczema can be due to an autoimmune abnormality." - Anonymous Online Contributor
"The pathogenesis of eczema is still unclear. Genetic and/or environmental factors are responsible for a significant proportion of the variance. The most likely environmental risk factors are stress, the presence of certain micro-organisms, and exposure to tobacco smoke in utero. Some of these factors are also thought to be involved in the pathogenesis of eczema in adults. Further research is necessary to elucidate the etiology of eczema, and to develop strategies for prevention and treatment." - Anonymous Online Contributor
"Approximately 7.8 million children are diagnosed with at least one chronic allergic disease at least once a year in the United States. Children with eczema have the highest odds of being diagnosed with at least one other chronic allergic disease, which occurs during adolescence (OR=3.36). Younger age of onset increases the likelihood of being diagnosed with any or a combination of three other allergies (OR=6.38-12.5), and/or allergic asthma (OR=5.14). Asthma is the most common chronic allergic disease seen in children with at least one of the other two allergies. Children with other allergic manifestations are less likely to be diagnosed with asthma than children without them." - Anonymous Online Contributor
"There is a new avenue for research into the biology of eczema, and much is being learned with the use of genetics and genomics. We are even discovering new ways to classify and diagnose eczema. Research for eczema can be accessed at [Power (http://power.withpowerweb.com)], but one has to be willing to wait for 4 or 5 years to see the results." - Anonymous Online Contributor
"Tapinarof cream had not been updated in 1 year, and the composition of the product had not been changed. The label stated that the product was approved for use by the US Food and Drug Administration. These indications that the label claimed may have been incorrect." - Anonymous Online Contributor
"Data from a recent study of the current study show that trials of topical corticosteroids are effective, warranting an urgent trial, for eczema of both toddlers and infants because these are the main group for which topical corticosteroids are available. For eczema patients with suspected allergy to corticosteroids, the recent results of a trial of omalizumab support the view that omalizumab has a beneficial effect." - Anonymous Online Contributor
"Tapinarof cream, 1%, is an effective, light to medium-acting, viscous emollient used in the treatment of mild-to-moderate atopic dermatitis for at least 8 weeks. The presence of a prescription or over-the-counter medicine or product should be stated on all application instructions." - Anonymous Online Contributor
"Although the exact causal relationship between eczema, infantile, and eczema, infantile is still unknown, ECZ is a disorder of the skin that involves allergic sensitization to environmental triggers and should be investigated further among families with ECZ, infantile eczema, and ECZ, infantile." - Anonymous Online Contributor
"Most people feel the product is well-tolerated, although the application technique may be problematic for some. The product can be used safely in a paediatric setting with a thorough explanation about why it is recommended during a topical consultation." - Anonymous Online Contributor