Clinical Research Directory
Browse clinical research sites, groups, and studies.
Efficacy and Safety Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
It is a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 clinical trial to evaluate the efficacy of QLM3003 ointment at week 8 based on the primary endpoint (EASI 75) and key secondary endpoint (IGA-TS).in patients with mild to moderate atopic dermatitis. A total of 360 patients with mild to moderate atopic dermatitis are planned to be included and randomized at a ratio of 1:1:1 to receive 1.5% QLM3003 ointment、2% QLM3003 ointment and placebo, twice a day.
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Assess Efficacy and Safety of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2025-05-16
Completion Date
2027-05
Last Updated
2025-08-26
Healthy Volunteers
No
Conditions
Interventions
1.5% QLM3003 ointment
QLM3003 topical cream; 1.5% cream applied twice daily (BID)
2% QLM3003 ointment
QLM3003 topical cream; 2% cream applied twice daily (BID)
QLM3003 Placebo
vehicle; vehicle applied twice daily (BID)
Locations (1)
The First Affiliated Hospital of China Medical University
Shenyang, China