Status:
COMPLETED
A Phase 2 Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess efficacy, safety, and pharmacokinetics (PK) of QLM3003 Ointment in participants with mild or moderate atopic dermatitis.
Detailed Description
This study is a Phase 2, randomized, double-blind,placebo controlled, parallel group study to assess efficacy, safety, and pharmacokinetics (PK) of QLM3003 Ointment in participants with mild or modera...
Eligibility Criteria
Inclusion
- The subjects understand and comply with the study requirements, voluntarily participate in the study and sign the informed consent form.
- Ages at ≥18 and ≤ 65 years.
- The diagnosis of atopic dermatitis will be confirmed according to the criteria of Hanifin and Rajka at the Screening Visit and Have a clinical diagnosis of atopic dermatitis for at least 6 months.
- Have an Investigator's Global Assessment (IGA) score of 2, or3 at screening and at baseline.
- Have atopic dermatitis on the head (excluding hair-bearing scalp), neck, trunk, or limbs, covering at least 2% of total BSA and up to and including 20% of total BSA at Screening and at baseline.
Exclusion
- Subjects with other dermatologic disease besides AD whose presence or treatments could interfere the assessment of disease (eg, psoriasis).
- In the opinion of the investigator, have any clinically significant laboratory abnormality that would affect the participant's participation in the study.
- Use of topical treatments for AD within 2 weeks of baseline.
- Vaccinated or exposed to a live or attenuated vaccine within the 12 weeks of baseline, or is expected to be vaccinated these vaccines during treatment.
- A history of alcohol or substance abuse within 12 months prior to Screening that in the opinion of the investigator will preclude participation in the study.
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06058000
Start Date
November 13 2023
End Date
September 30 2024
Last Update
March 12 2025
Active Locations (2)
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1
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
2
Dermatology Hospital of Shandong First Medical University
Jinan, Shandong, China, 276000