This trial is evaluating whether Dupilumab SAR231893 will improve 15 secondary outcomes in patients with Eczema, Infantile. Measurement will happen over the course of Baseline to Week 21.
This trial requires 23 total participants across 2 different treatment groups
This trial involves 2 different treatments. Dupilumab SAR231893 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.
In children with eczema, a child's skin should be reassessed every 6-8 weeks until signs of resolution have been documented. The child's skin should be monitored once a year for 2-3 years after resolution of the eczema. If the skin looks normal, children with eczema can be reassured that their eczema is resolved and can return to normal life.
Eczema, infantile, is a common condition where infants swell up, sometimes causing the skin to crack and bleed. It is more common in babies than adults and typically takes between 3 months and 2 years to get better. It is also very common, affects around 1% of babies or one in 250, which might be an underestimate, as some mothers do not complain about the condition. It is likely to set in later childhood or even late in life. It is not contagious. Eczema, infantile, can be diagnosed by a skin biopsy.
There is no one set of signs that is always present. Symptoms vary by patient. It is important to think of eczema in a holistic way as a disorder that manifests on different parts of the body at different times throughout a child's life. The same child may have the same eczema in different parts of their body, or different children may have different eczema on the same part of their body in the same child.
Common treatments for eczema, infantile are topical corticosteroids, topical antifungal medications, oral or inhaled corticosteroids, antihistaminic treatments, or combinations of these. For severe, corticosteroid-refractory eczema, referral to a dermatologist is strongly advised.
There is a high rate of eczema in children in the United States, with nearly 3 percent and 13 percent of children having at least one and over two episodes, respectively, of eczema for 6 months or longer. The National Health and Nutrition Examination Survey (NHANES) reports an approximate national prevalence of 14 percent for eczema and its subtypes. The prevalence of eczema and its subtypes increases in the general population with increasing age and with increasing severity; however, the prevalence between races or ethnic groups is similar. Eczema, especially atopic dermatitis and total eczema, should be considered as potentially modifiable risk factors of increased incidence of some adult diseases, including cancer.
Different factors, including genetics, early life infection and allergy, have been suggested as causes for eczema, infantile. These factors appear to interact with each other in order to cause the development of eczema in early childhood. The lack of understanding of the causes of eczema, infantile prevents the development of effective treatment and, therefore, the disease lasts a prolonged time in childhood.
The common side effects of dupilumab sar231893 include headache, insomnia, and headache worsened by use of opioids or alcohol. Dupilumab sar231893 also causes a rare, but serious, skin hypersensitivity reaction characterized by a pruritic rash, redness, swelling at the injection site, and inflammation. Dupilumab sar231893 should only be used if very clearly needed.
In North American studies, the average age of diagnosis is 5.9 years. Other studies show the rate between 3 and 10 years. It is important to know how often a parent or baby gets eczema so that a doctor can diagnose it early.
This is the first report to mention dupilumab sar231893, an experimental therapy to block IL-23, in scientific journals. To our knowledge, this is the first report for dupilumab treatment in adults. We think that the potential benefit for patients who lack IL-12/23 activity justifies the development of more advanced therapies. Clinical trials are warranted for Dupilumab sar231893 in different diseases.
The clinical trials for eczema are not accessible to people with eczema and are not tailored to the individual needs of each person with eczema. Doctors and nurses who care for people with eczema should be informed of the limitations of the limited information available in the published clinical trials and should be able to address those needs, as well as helping patients to obtain a well-informed decision on which trials to choose.
This is the first study that has identified, quantified, and associated an increased concentration of circulating immunoglobulin A in infants with eczema compared with in infants without eczema.
All medications have limited efficacy in treating infantile eczema. There are no new discoveries for treating eczema during the past decade. It is an older disease. Several new medications are being tested in clinical trials for a possible future treatment.