KM110329 in adult patients with atopic dermatitis: a randomised, double-blind, placebo-controlled, multicentre trial – study protocol

Table 1 Study schedule of KM110329 clinical trial (8 weeks)

	Screening	Treatment period
	Visit 1	Visit 2	Visit 3	Visit 4	Visit 5
	(D − 7)	(D 0)	(D 7)	(D 28)	(D 56)
Informed consent	√
Demographic characteristic eristic	√
SCORAD index	√	√	√	√	√
Dermatology Life Quality Index		√	√	√	√
KiFDA-HM-AD		√	√	√	√
Laboratory tests ¹	√	√			√
Test for chronic hepatitis ²	√
Drug use history	√
Concomitant medication	√	√	√	√	√
Pregnancy test	√	√	√	√	√
Medical/drug use history	√	√	√	√	√
Adverse event			√	√	√
Compliance calculation			√	√	√
Inclusion/exclusion criteria check	√
Randomisation		√

¹CBC (RBC, Hb, Hct, WBC, Platelet, ESR), Immunological tests (Eosinophil, IgE, IL-4, IL-5, IL-13), Liver function tests (AST, ALT), Renal function tests (BUN, Creatinine).
²Anti-HBs, HBsAg.

ISSN: 2662-7671