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The purpose of this study is to assess the differential expression of AD biomarkers in serum, plasma, and skin biopsies from both lesional and non-lesional skin in moderate to severe AD patients in the presence of TCS and after withdrawal from TCS.
Full description
This exploratory study consists of four visits to the investigator site post screening: at Weeks 0 (baseline), 2, 6 and 8 (Figure 1). At the first visit (baseline), patients who have met the screening eligibility criteria will be started on a stable TCS regimen for a total of two weeks. At the second visit (Week 2) following two weeks of therapy on stable TCS, patients will stop TCS and blood, serum, plasma and two 6mm punch biopsies (one lesional (L) and one non-lesional (NL) skin) will be obtained. At the third visit (Week 6), after four weeks receiving no TCS, the same sample collections will be repeated and the patients will then enter a two week safety follow up. At the end of the safety follow up (last visit, Week 8) and after obtaining written informed consent by the patient, blood, serum and plasma samples mav be collected.
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Inclusion criteria
Male or female patients 18-75 years of age
AD diagnosed by the Rajka/Hanifin criteria at the time of screening and that has been present for at least 1 year
History of inadequate response to a stable regimen of TCS for 1 month (in the 3 months immediately preceding the screening visit) as treatment for their AD
Eczema Area and Severity Index (EASI) score ≥ 14 at the screening and baseline visits
Investigator's Global Assessment (IGA; 5-point) score ≥ 3 at the screening and baseline visits
≥10% body surface area involvement by AD
A washout period prior to screening for those patients who have previously received the following medications:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
11 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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