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#Alopecia areata universalis treatment skin

While on investigational product and for at least 28 days after taking the last dose of investigational product (IP), FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:

Subject is able to adhere to the study visit schedule and other protocol requirements.įemales of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline.

Subject is able to understand and voluntarily sign an informed consent document prior to participation.

Male or female subjects who are at least 18 years old at the time of informed consent.

If, at a later date, correlations of in-vitro tests and the patients' clinical situation suggest that the results do bear on the patients' health, an amended protocol will be submitted to the IRB so that results can be made available to the medical record. Since this study is designed to gain basic knowledge rather than to yield information directly related to patient care, the results are not entered in the participants' medical records.

Both the whole genomic profiling and individual molecular and cellular markers are very important in order to understand how well anti-IL-13 will change/suppress AA-associated pathways and compare with those that will be suppressed in AD.

#Alopecia areata universalis treatment skin

It is very important to associate the clinical responses with suppression of this cytokine and related molecules as well as other pathway cytokines in skin tissues. Data shows that IL-13 is significantly upregulated in both AD and AA lesions compared to nonlesional skin. These mechanistic studies coupled with clinical trials are key in the disease to shed light on important disease mechanisms, and to explain which molecules are suppressed by each therapeutic target. The researchers' experience in AD, and past experience in psoriasis showed that biomarker studies in skin tissues are critical to the understanding of key pathogenic pathways that are upregulated in each disease and how well they are suppressed with effective treatment. The researchers expect one third of these subjects to have concomitant alopecia areata (AA) and atopic dermatitis (AD). This is a randomized, double-blind, placebo-controlled pilot study of a total of 54 subjects with moderate to severe alopecia areata involving 30-100% of the scalp. The purpose of this study is to assess whether dupilumab can be a helpful treatment for alopecia areata. Why Should I Register and Submit Results?.