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A multicenter, randomized, double-blind, vehicle-controlled, parallel group trial to demonstrate the superiority of 0.3% and 1% OPA-15406 ointment to vehicle in pediatric subjects with AD. This trial consists of the 0.3% OPA-15406 group, the 1% OPA-15406 group, and the vehicle group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.3% OPA-15406 Ointment | Experimental | The 0.3% formulation of OPA-15406 ointment will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated. |
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| 1% OPA-15406 Ointment | Experimental | The 1% formulation of OPA-15406 ointment will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated. |
|
| 0% OPA-15406 Vehicle | Placebo Comparator | The 0% formulation of OPA-15406 venicle will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.3% OPA-15406 Ointment | Drug | Twice-daily administration for 4 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate in Investigator's Global Assessment at Week 4 | Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by percentage of subjects with Investigator's Global Assessment score of 0 or 1 with improvement by at least 2 grades from baseline. Subjects with missing Investigator's Global Assessmen data will be handled as non-responders. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Investigator's Global Assessment at Week 4 | Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by the change from baseline in Investigator's Global Assessment at Week 4. |
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Inclusion Criteria:
Exclusion Criteria:
1. Subjects who defined as AD or contact dermatitis rapid deterioration, within 28 days prior to the baseline visit.
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| Name | Affiliation | Role |
|---|---|---|
| Lin Ma | Beijing Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University | Beijing | Beijing Municipality | 100045 | China |
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| 1% OPA-15406 Ointment |
| Drug |
Twice-daily administration for 4 weeks. |
|
| 0% OPA-15406 vehicle | Other | Twice-daily administration for 4 weeks. |
|
| 4 weeks |
| Success rate in Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index) and at Week 4. | Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by success rate in Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index) and at Week 4. | 4 weeks |
| Success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index) and at Week 4. | Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by the success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index) at Week 4. | 4 weeks |
| Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index) at week 4 | Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by success rate in Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index) and at Week 4. | 4 weeks |
| Change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score at Week 4 | Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score at Week 4. | 4 weeks |
| Change from baseline in Verbal Rating Scale for Pruritus at Week 4 | The Verbal Rating Scale measures the intense pruritus in the past 24 hours following Verbal Rating Scale criteria( 0: None,1: Mild, 2: Moderate, 3: Severe). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by Change from baseline in Verbal Rating Scale for Pruritus at Week 4 | 4 weeks |
| Change from baseline in Verbal Rating Scale for pruritus up to Day 7 | The Verbal Rating Scale measures the intense pruritus in the past 24 hours following Verbal Rating Scale criteria( 0: None,1: Mild, 2: Moderate, 3: Severe). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's/subjects' judgment. The efficacy is assessed by Change from baseline in Verbal Rating Scale for Pruritus up to day 7. | 7 Days |
| Change from baseline in the total score of Patient-Oriented Eczema Measure at Week 4 | Eczema will be evaluated according to Patient-Oriented Eczema Measure .The subjects will answer 7 questions and describe their eczema. The investigator will confirm their responses and record the results in the source document and CRF. The total score of POEM is 28 points at the most. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by Change from baseline in the total score of Patient-Oriented Eczema Measure at Week 4 | 4 Weeks |
| Change from baseline in the total affected Body Surface Area (percent) at Week 4 | The efficacy is assessed by change from baseline in the total affected Body Surface Area (percent) at Week 4. | 4 weeks |
| Success rate in Investigator's Global Assessment | Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by percentage of subjects with Investigator's Global Assessment score of 0 or 1 with improvement by at least 2 grades. | 24 Weeks |
| Time to Investigator's Global Assessment response | Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by time to Investigator's Global Assessment response (Investigator's Global Assessment score of 0 or 1, with improvement by at least 2 grades). | Within 24 Weeks |
| Success rate in Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index) | Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by success rate in Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index). | 24 Weeks |
| Success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index) | Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index). | 24 Weeks |
| Success rate in Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index) | Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by success rate in Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index). | 24 Weeks |
| Change from baseline in Investigator's Global Assessment | Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by the change from baseline in Investigator's Global Assessment. | 24 Weeks |
| Change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score | Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score. | 24 Weeks |
| Change from baseline in the total score of Patient-Oriented Eczema Measure | Eczema will be evaluated according to Patient-Oriented Eczema Measure .The subjects will answer 7 questions and describe their eczema. The investigator will confirm their responses and record the results in the source document and CRF. The total score of POEM is 28 points at the most. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by Change from baseline in the total score of Patient-Oriented Eczema Measure. | 24 Weeks |
| Change from baseline in the total affected Body Surface Area (percent) | The efficacy is assessed by change from baseline in the total affected Body Surface Area (percent). | 24 Weeks |
| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000711049 | difamilast |
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