- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03018691
Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis
A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Trial to Assess the Safety and Efficacy of 0.3% and 1% OPA-15406 Ointments When Administered for 4 Weeks in Pediatric Patients With Atopic Dermatitis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Hokkaido Region, Japan
-
Kanto Region, Japan
-
Kinki Region, Japan
-
Kyushu Region, Japan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka
Exclusion Criteria:
- Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a sudden intensification of atopic dermatitis.
- Subjects who have an active viral skin infection.
- Subjects with a current or history of malignancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0.3% OPA-15406 Ointments
Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.
|
|
Experimental: 1% OPA-15406 Ointments
Subjects were treated with assigned 1% OPA-15406 ointment twice daily.
|
|
Placebo Comparator: Placebo Ointments
Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number of Subjects Experiencing AEs
Time Frame: Week 0-4
|
The number of subjects experiencing AEs will be calculated for each treatment group. Treatment-emergent adverse events (TEAEs) occurring after the start of IMP administration are summarized. The number of subjects with events, the number of events is obtained for all the TEAEs reported. |
Week 0-4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Responder Rate of Investigator's Global Assessment(IGA) of Disease Severity at Week4
Time Frame: Baseline and Week 4
|
The investigator or subinvestigator assessed the skin symptoms using IGA.
The investigator or subinvestigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week4.
Incidence of success in IGA was defined as the rate of subjects whose IGA score was 0 (clear) or 1 (almost clear) and had improved by at least 2 grades (responders) from baseline.
|
Baseline and Week 4
|
Change From Baseline in Eczema Area and Severity Index (EASI) Score
Time Frame: Baseline, Week 4
|
The investigator or sub investigator assessed the symptoms of AD using EASI.
EASI's minimum and maximum scores are 0 and 72 scores respectively.
The higher the EASI score is, the more severe the symptoms of AD, and a negative change from the baseline means improvement and a positive change means worsening.
The investigator or sub investigator scored the severity (0-3 points) and affected BSA (%) based on the 4 symptoms (erythema, infiltration/papules, excoriation, and lichenification) on the 4 body regions (face, neck and head ; upper limbs ;; and lower limbs).
Number of participants analyzed represents number of participants with data at both Baseline and Week4.
Participants who have no data were excluded.
|
Baseline, Week 4
|
Change From Baseline in Visual Analogue Scale(VAS) for Pruritus Score
Time Frame: Baseline, Week 4
|
The investigator or subinvestigator evaluated the level of pruritus based on VAS.
The subjects aged 7 to 14 years old marked the point of pruritus intensity during the last 24 hours on a 0 to 100mm VAS, with 0 being no pruritis to 100 being very severe pruritis.For subjects aged 2 to 6 years, this would not be evaluated.
The negative value showed the degree of improvement.
|
Baseline, Week 4
|
Change From Baseline in Verbal Rating Scale(VRS) for Pruritus Score
Time Frame: Baseline, Hour 156
|
The investigator or subinvestigator evaluated the pruritus intensity based on VRS. The subjects aged 7 to 14 years old evaluated the pruritus intensity according to the following criteria. The subjects recorded the level of pruritus and the time and date of evaluation in a pruritus diary. 0 : None
|
Baseline, Hour 156
|
Change From Baseline in Patient-Oriented Eczema Measure(POEM) Score
Time Frame: Baseline, Week 4
|
The investigator or sub investigator evaluated eczema according to the POEM.
The subjects answered 7 questions about their eczema by 0-4 points per question.
The POEMS's minimum and maximum scores are 0 and 28 scores respectively.
The higher the POEM score is, the more severe the symptoms are, and a negative change from the baseline means improvement and a positive change means worsening.
If it is difficult for subjects to answer the questions, their parents answered them instead.
Number of participants analyzed represents number of participants with data at both Baseline and Week4.
Participants who have no data were excluded.
|
Baseline, Week 4
|
Change From Baseline in Percentage Affected Body Surface Area
Time Frame: Baseline, Week 8, 16, 24
|
The investigator or subinvestigator drew the affected BSA (range of skin eruption at the time of examination) on the human body drawing to determine the affected areas (%) on the respective 4 body regions (face, neck, and head; upper limbs; trunk; and lower limbs).
One palm of the subject corresponds to 1% BSA.
The negative value showed the degree of improvement.
|
Baseline, Week 8, 16, 24
|
Mean (SD) OPA-15406 Plasma Trough Concentrations at week1
Time Frame: Week 1
|
The plasma concentration of OPA-15406 was measured at Week 1.
On the day of measurement, the subjects visited the trial site without morning Investigational Medicinal Product (IMP) administration.
|
Week 1
|
Mean (SD) OPA-15406 Plasma Trough Concentrations at week4
Time Frame: week4
|
The plasma concentration of OPA-15406 was measured at Week 4. On the day of measurement, the subjects visited the trial site without morning Investigational Medicinal Product (IMP) administration.
|
week4
|
Mean (SD) Normalized OPA-15406 Plasma Trough Concentrations by Dose Derived From %BSA at week1
Time Frame: week1
|
The plasma concentration of OPA-15406 was measured at Week 1.
On the day of measurement, the subjects visited the trial site without morning Investigational Medicinal Product (IMP) administration.Each plasma concentration was normalized by dose.
|
week1
|
Mean (SD) Normalized OPA-15406 Plasma Trough Concentrations by Dose Derived From %BSA at week4
Time Frame: week4
|
The plasma concentration of OPA-15406 was measured at Week 4. On the day of measurement, the subjects visited the trial site without morning Investigational Medicinal Product (IMP) administration.Each plasma concentration was normalized by dose.
|
week4
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 271-102-00002
- JapicCTI-173484 (Other Identifier: Japic)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atopic Dermatitis
-
Catalysis SLCompletedAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related Conditions | Atopic Dermatitis \(AD\)Serbia
-
Jacob Pontoppidan ThyssenThe Novo Nordic FoundationRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis FlareDenmark
-
ShaperonRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis of ScalpUnited States
-
University of California, San FranciscoSanofi; Regeneron PharmaceuticalsRecruitingEczema | Atopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related ConditionsUnited States
-
PfizerActive, not recruitingEczema | Atopic Dermatitis | Eczema, Atopic | Atopic Dermatitis, UnspecifiedUnited States, Canada, Czechia, Poland
-
AmgenCompletedDermatitis, Atopic DermatitisCanada, United States, Japan
-
SanofiCompletedAtopic Dermatitis | Dermatitis AtopicChina
-
SanofiCompletedDermatitis AtopicSaudi Arabia, Kuwait, United Arab Emirates
-
Hadassah Medical OrganizationUnknownATOPIC DERMATITIS
-
Regeneron PharmaceuticalsSanofiRecruitingModerate-to-Severe Atopic Dermatitis | Atopic EczemaUnited States
Clinical Trials on OPA-15406
-
Otsuka Pharmaceutical Co., Ltd.Completed
-
Otsuka Beijing Research InstituteRecruiting
-
Otsuka Beijing Research InstituteRecruitingAtopic Dermatitis (AD)China
-
Otsuka Pharmaceutical Co., Ltd.CompletedAtopic DermatitisJapan
-
Otsuka Pharmaceutical Co., Ltd.CompletedAtopic DermatitisJapan
-
Otsuka Pharmaceutical Development & Commercialization...CompletedAtopic DermatitisPoland, United States, Australia
-
Otsuka Pharmaceutical Co., Ltd.CompletedAtopic DermatitisJapan
-
Otsuka Pharmaceutical Co., Ltd.Completed
-
Otsuka Pharmaceutical Co., Ltd.Completed
-
Medimetriks Pharmaceuticals, IncCompletedAtopic DermatitisUnited States, Honduras, Panama