NCT06058000CompletedPhase 2
A Phase 2 Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis
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 Moderate Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 12 Mar 2025
Brief summary (registry, in English)
The purpose of this study is to assess efficacy, safety, and pharmacokinetics (PK) of QLM3003 Ointment in participants with mild or moderate atopic dermatitis.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 21 Sept 2023
- Start date
- 13 Nov 2023
- Primary completion date
- 2 Sept 2024
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06058000
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 120
- From 13 Nov 2023 to the primary completion date, 2 Sept 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Subjects with other dermatologic disease besides AD whose presence or treatments could interfere the assessment of disease (eg, psoriasis).
Lab values
- In the opinion of the investigator, have any clinically significant laboratory abnormality that would affect the participant's participation in the study.
Other
- Use of topical treatments for AD within 2 weeks of baseline.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dermatology Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.