RecruitingPhase 3NCT06880276

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


Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

360 participants

Start Date

May 16, 2025

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 1.5% QLM3003 ointment, a drug called 2% QLM3003 ointment, and others for people with atopic dermatitis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG1.5% QLM3003 ointment

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

DRUG2% QLM3003 ointment

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

DRUGQLM3003 Placebo

vehicle; vehicle applied twice daily (BID)


Locations(1)

The First Affiliated Hospital of China Medical University

Shenyang, China

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NCT06880276


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