Atopic DermatitisPhase 2NCT06058000
A Phase 2 Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis
A Phase 2 study testing 1.5% QLM3003 and 2% QLM3003 in people with Atopic Dermatitis, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- 1.5% QLM3003 and 2% QLM3003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 13 Nov 2023to 30 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Dermatology Hospital of Shandong First Medical University
Jinan, Shandong, 276000
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: 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
The purpose of this study is to assess efficacy, safety, and pharmacokinetics (PK) of QLM3003 Ointment in participants with mild or moderate atopic dermatitis.
Read the 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 moderate atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- 1.5% QLM3003, 2% QLM3003, Vehicle (Placebo)
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.5% QLM3003Drug
QLM3003 topical cream
2% QLM3003Drug
QLM3003 topical cream
Vehicle (Placebo)Drug
Vehicle topical cream
| Study group | Role | What they receive |
|---|---|---|
| QLM3003 Low Dose | Experimental | 2% cream applied once daily (QD) Receives: Drug: 2% QLM3003 |
| QLM3003 Middle Dose | Experimental | 1.5% cream applied twice daily (BID) Receives: Drug: 1.5% QLM3003 |
| QLM3003 High Dose | Experimental | 2% cream applied twice daily (BID) Receives: Drug: 2% QLM3003 |
| Placebo Comparator: Vehicle | Placebo comparator | Vehicle cream applied twice daily (BID) Receives: Drug: Vehicle (Placebo) |
| High Placebo Comparator: Vehicle | Placebo comparator | Vehicle cream applied twice daily (BID) Receives: Drug: Vehicle (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 8
EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Measured: Baseline, Weeks 8
Secondary outcomes (1)
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 8
IGA assesses severity of participant's AD on a 5 point scale. 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting and 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Higher scores indicating more severity of AD. Assessment excluded soles, palms and scalp.
Measured: Baseline, Weeks 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start13 Nov 2023
- Primary completion2 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xinghua Gao, Doctor, Principal investigator, First Hospital of China Medical UniversityFuren zhang, Doctor, Principal investigator, Dermatology Hospital of Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058000
- Sponsor's protocol ID
- QLM3003-201
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06058000
- Acronym / sponsor ID
- QLM3003-201
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 2 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 moderate atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| QLM3003 Low Dose | Experimental | Drug: 2% QLM30032% cream applied once daily (QD) |
| QLM3003 Middle Dose | Experimental | Drug: 1.5% QLM30031.5% cream applied twice daily (BID) |
| QLM3003 High Dose | Experimental | Drug: 2% QLM30032% cream applied twice daily (BID) |
| Placebo Comparator: Vehicle | Placebo comparator | Drug: Vehicle (Placebo)Vehicle cream applied twice daily (BID) |
| High Placebo Comparator: Vehicle | Placebo comparator | Drug: Vehicle (Placebo)Vehicle cream applied twice daily (BID) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1.5% QLM3003QLM3003 topical cream | Drug | QLM3003 Middle Dose |
| 2% QLM3003QLM3003 topical cream | Drug | QLM3003 High Dose, QLM3003 Low Dose |
| Vehicle (Placebo)Vehicle topical cream | Drug | High Placebo Comparator: Vehicle, Placebo Comparator: Vehicle |
Primary outcome
Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 8
Time frame: Baseline, Weeks 8
EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
1 secondary outcome
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 8
Time frame: Baseline, Weeks 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinghua Gao, Doctor principal investigator
First Hospital of China Medical University
Furen zhang, Doctor principal investigator
Dermatology Hospital of Shandong First Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1.5% QLM3003 and 2% QLM3003 in people with Atopic Dermatitis, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 8 (time frame: Baseline, Weeks 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.