The objective of this phase 2 study is to evaluate the safety and efficacy of HL-009 Liposomal Gel in adult patients with mild to moderate atopic dermatitis (AD).
This is a randomized, double-blind, placebo-controlled, parallel-group comparison study in subjects with mild to moderate AD. Following a 2-week screening period, subjects will be randomly assigned into one of four treatment arms. Placebo or HL-009 study treatments will be administrated to subjects twice daily for 8 consecutive weeks. After the randomization at Week 0 (Visit 2), subjects will visit their respective trial sites at Weeks 0.5, 1, 2, 4, 6, 8, and 10 (Visits 3, 4, 5, 6, 7, 8, and 9). All study drugs will be in identical laminated tubes to preserve double-blinding of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Topical adenosylcobalamin gel
Placebo gel
Unnamed facility
Arlington Heights, Illinois, United States
Unnamed facility
Fridley, Minnesota, United States
Unnamed facility
Berlin, New Jersey, United States
Unnamed facility
Winston-Salem, North Carolina, United States
Score change from baseline on IGA at Week 8
Time frame: Weeks 0, 1, 2, 4, 6, and 8
Percentage of subjects who have a minimum of 2-point improvement in IGA score at Week 8
Time frame: Weeks 0, 1, 2, 4, 6, and 8
Score change from baseline on EASI at Week 8
Time frame: Weeks 0, 1, 2, 4, 6, and 8
Score change from baseline on VAS for pruritus at Week 8
Time frame: Weeks 0, 1, 2, 4, 6, and 8
Score change from baseline on DLQI at Week 8
Time frame: Weeks 0, 1, 2, 4, 6, and 8
Score change from baseline on SF-36 questionnaires at Week 8
Time frame: Weeks 0, 4, and 8
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Unnamed facility
South Euclid, Ohio, United States
Unnamed facility
Portland, Oregon, United States
Unnamed facility
Austin, Texas, United States