A Phase 2 Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis
Atopic Dermatitis
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- The First Hospital of China Medical University
- Dermatology Hospital of Shandong First Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
QLM3003 Low Dose
QLM3003 Middle Dose
QLM3003 High Dose
Placebo Comparator: Vehicle
High Placebo Comparator: Vehicle
2% cream applied once daily (QD)
1.5% cream applied twice daily (BID)
2% cream applied twice daily (BID)
Vehicle cream applied twice daily (BID)
Vehicle cream applied twice daily (BID)