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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.5% QLM3003 ointment | Experimental | QLM3003 ointment; 1.5% |
|
| 2% QLM3003 ointment | Experimental | QLM3003 ointment; 2% |
|
| Placebo | Placebo Comparator | Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1.5% QLM3003 ointment | Drug | QLM3003 topical cream; 1.5% cream applied twice daily (BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingxia Lv, Master | Contact | 13256161060 | mingxia.lv@gilu-pharma.com | |
| Xinghua Gao, Doctor | Contact | 024-83283391 | gaobarry@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xinghua Gao, Doctor | First Hospital of China Medical University | Study Director |
| Furen zhang, Doctor | Dermatology Hospital of Shandong First Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of China Medical University | Recruiting | Shenyang | China |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| 2% QLM3003 ointment | Drug | QLM3003 topical cream; 2% cream applied twice daily (BID) |
|
| QLM3003 Placebo | Drug | vehicle; vehicle applied twice daily (BID) |
|
| Baseline, Week 8 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |