Actively Recruiting
Efficacy and Safety Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2025-08-26
360
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18-75 years old
- Diagnosis of atopic dermatitis meeting Hanifin-Rajka standards
- History of atopic dermatitis or eczema for at least 1 year before screening
- Investigator's Global Assessment (IGA) score of 2 or 3
- Atopic dermatitis involving head and neck (excluding scalp), trunk, and limbs
- Total affected body surface area (BSA) between 3% and 20% inclusive
You will not qualify if you...
- Other medical conditions that could interfere with study assessments as judged by the investigator
- Unstable atopic dermatitis with spontaneous improvement or rapid worsening
- Use of marketed or investigational biologics for atopic dermatitis within 3 months or 5 half-lives before baseline
- Use of systemic or topical JAK inhibitors within 4 weeks or 5 half-lives before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of China Medical University
Shenyang, China
Actively Recruiting
Research Team
M
Mingxia Lv, Master
CONTACT
X
Xinghua Gao, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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