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Efficacy and Safety Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis

NCT06880276 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-08-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

1.5% QLM3003 ointment

QLM3003 topical cream; 1.5% cream applied twice daily (BID)

DRUG

2% QLM3003 ointment

QLM3003 topical cream; 2% cream applied twice daily (BID)

DRUG

QLM3003 Placebo

vehicle; vehicle applied twice daily (BID)

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xinghua Gao, Doctor · First Hospital of China Medical University

  • Furen zhang, Doctor · Dermatology Hospital of Shandong First Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-16
Primary Completion
2027-03-31
Completion
2027-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06880276 on ClinicalTrials.gov