This trial is evaluating whether CC-93538 will improve 1 primary outcome and 11 secondary outcomes in patients with Eczema, Infantile. Measurement will happen over the course of Up to week 16.
This trial requires 214 total participants across 4 different treatment groups
This trial involves 4 different treatments. CC-93538 is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
The prevalence of eczema, infantile in the US is 6.1%, higher than those studied with the U.S. NHANES in 1988 of 4.4%. The rate in 2005-2006 in a large metropolitan clinic in the USA is 7.1% with an estimated lifetime prevalence of 2.4% or an estimated prevalence of 6.11% per person. This appears to be the first study utilizing a broad definition of eczema, infantile. As for allergic rhinitis, 2% of patients in children as per the national study reported experiencing it and 1% reported having it last year. There was no significant difference in reporting between patients with atopic and nonatopic eczema.
Eczema tends to be persistent despite medications, and many patients seek a referral from their doctor, who may prescribe immunosuppressive agents (such as tacrolimus) or topical steroids. For those who are allergic to corticosteroids, alternative products with less or no steroid (e.g., topical cortisone) are often prescribed.
Eczema, infantile is a generalized condition with several different manifestations. We are only able to summarize and compare a few signs that can happen with any of the different forms of eczema, infantile. See Eczema symptoms and Signs.. There is no known or effective cure for eczema, infantile, for either adults or children. Doctors' attention will help to provide more information about the various forms of eczema, infantile.
There is an increasing recognition that multiple factors are involved in the pathogenesis of eczema and must be identified and treated as early as possible. There may be multiple 'injury mechanisms' operating.
Despite early recognition of eczema, a cure is not likely. Eczematous individuals are probably predisposed to infection, requiring regular and stringent hand washing and careful medical management.
Eczema is a chronic inflammatory skin disorder with different subtypes ranging from mild and mild to severe and severe form of the disease. Infantile eczema affects 5-10 percent of children in Europe and 2-4 percent in the US. Patients present with scaling on the skin, redness, itching, burning, pain, and sometimes swelling from inflammation. Some forms of the disease can affect the eyes, mucous membranes, nose, or throat. Treatment for infantile eczema often consists of topical steroids and topical hydrocortisone creams. Patients may need to repeat the treatment over time as the child grows.
Newer discoveries are bringing about changes in the treatment of eczema and we hope that these advances will also offer a new hope for an infantile that needs a solution as well.
The most commonly cited causes of eczema infantile include [atopy & contact dermatitis & chemical irritant contact dermatitis / occupational contact dermatitis] are not the only likely triggers. Other environmental factors may play a role in eczema infantile.
A novel class of synthetic, first-in-class, small molecule CCR2/CCL2 receptor modulators is described that inhibits a range of important immune, inflammatory, and allergic responses. This includes inhibition of T cell activation, IgE receptor-dependent mast cell degranulation, inflammatory cell infiltration, CCL2-driven leukocyte recruitment, and allergic symptom-reactivity. In addition, a novel CCR2-specific monoclonal antibody and synthetic small molecule CC-93538 are shown to inhibit the responses induced by specific inflammatory mediators such as IL-1β, interleukin-6, and IL-13.
The most common side effects of cc-93538 are headache and rash, which may occur because of its mechanism of action. However, most patients were still able to complete the study. If it were to be used therapeutically, the main advantage would be its improved toxicity profile relative to other second generation H 3 receptors antagonists. However, the clinical trial in which it was tested did not demonstrate superiority over the second generation H 3 receptor antagonists.
We used cc-93538 to prove that c-Kit plays an important role for the development of human airway epithelial cells. The PI3K/Akt pathway is involved in the regulation of the expression of the c-Kit receptor on human airway epithelial cells. Therefore, PI3K/Akt signaling may be a novel target to inhibit epithelial-mesenchymal transformation in pulmonary fibrosis by blocking cc-93538.
The newly developed bivalirudin and apixaban derivatives appear to be potent inhibitors for thrombin and FXa that may have a role for future antithrombotic therapy. The new derivatives may also provide insights into the thrombin receptor and FXa receptor activation and inhibition and the function of the thrombin clotting time.