The purpose of this study is to evaluate the efficacy and safety profiles of E6005 ointment in patients with atopic dermatitis compared to vehicle. The pharmacokinetic profile after topical application of E6005 is also assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
78
0.0% E6005 ointment applied twice daily for 4 weeks (vehicle-controlled phase), and then, following 8-week is extension phase which all subjects receive 0.2% E6005 ointment twice daily. Subjects are randomized to either 0.2% E6005 ointment group or vehicle group at a ratio of 2:1.
0.2% E6005 ointment applied twice daily for 4 weeks (vehicle-controlled phase), and then, following 8-week is extension phase which all subjects receive 0.2% E6005 ointment twice daily. Subjects are randomized to either 0.2% E6005 ointment group or vehicle group at a ratio of 2:1.
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Urayasu-shi, Chiba, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Asahikawa-shi, Hokkaido, Japan
Changes of pruritus score from baseline
Time frame: From baseline through 12 weeks
Changes of eczema area and severity from baseline
Time frame: From baseline through 12 weeks
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Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Yokohama, Kanagawa, Japan
Unnamed facility
Adachi-ku, Tokyo, Japan
Unnamed facility
Chiyoda-ku, Tokyo, Japan
Unnamed facility
Minato-ku, Tokyo, Japan
Unnamed facility
Shinagawa-ku, Tokyo, Japan