Efficacy and Safety Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis
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
Qilu Pharmaceutical Co., Ltd.
360 participants
May 16, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
QLM3003 topical cream; 1.5% cream applied twice daily (BID)
QLM3003 topical cream; 2% cream applied twice daily (BID)
vehicle; vehicle applied twice daily (BID)
Locations(1)
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NCT06880276