- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02914548
Study of OPA-15406 Ointment in Patients With Atopic Dermatitis
A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Assess the Efficacy and Safety of 0.3% and 1% OPA-15406 Ointments in Patients With Atopic Dermatitis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Hokkaido Region, Japan
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Kanto Region, Japan
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Kiniki Region, Japan
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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
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 0.3% OPA-15406
Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.
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Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.
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EXPERIMENTAL: 1% OPA-15406
Subjects were treated with assigned 1% OPA-15406 ointment twice daily.
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Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.
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PLACEBO_COMPARATOR: Placebo
Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
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Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Responder Rate of Investigator's Global Assessment(IGA) of Disease Severity at Week4
Time Frame: At Week 4
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The investigator or sub investigator assessed the skin symptoms using IGA.
The investigator or sub investigator 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.
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At Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Patient-Oriented Eczema Measure(POEM) Score
Time Frame: Baseline, Week 4
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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.
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Baseline, Week 4
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Change From Baseline in Eczema Area and Severity Index (EASI) Score
Time Frame: Baseline, Week 4
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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 ;trunk; 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.
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Baseline, Week 4
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Change From Baseline in Visual Analogue Scale(VAS) for Pruritus Score
Time Frame: Baseline, Week 4
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The investigator or subinvestigator evaluated the level of pruritus based on VAS.
The subjects will mark the point of pruritus intensity during the last 24 hours on the line of a 100- mm VAS sheet between the left end (no pruritus: the score is 0 ) and the right end (very severe pruritus: the score is 100), and a negative change from the baseline means improvement and a positive change means worsening.
Number of participants analyzed represents number of participants with data at both Baseline and Week4.
Participants who have no data were excluded
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Baseline, Week 4
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Change From Baseline in Verbal Rating Scale(VRS) for Pruritus Score
Time Frame: Baseline, Hour 156
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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
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Baseline, Hour 156
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Change From Baseline in Percentage Affected Body Surface Area
Time Frame: Baseline, Week 4
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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.
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Baseline, Week 4
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Mean (SD) OPA-15406 Plasma Trough Concentrations
Time Frame: Week1, Week4, Week8
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The plasma concentration of OPA-15406 was measured at Week1, Week4 and Week8. On the day of measurement, the subjects visited the trial site without morning Investigational Medicinal Product (IMP) administration. Number of participants analyzed represents number of participants with data at each point. Participants who have no effective data were excluded. |
Week1, Week4, Week8
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Mean (SD) Normalized OPA-15406 Plasma Trough Concentrations by Dose Derived From %BSA
Time Frame: Week1, Week4, Week8
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The plasma concentration of OPA-15406 was measured at Week1, Week4 and Week8.
On the day of measurement, the subjects visited the trial site without morning Investigational Medicinal Product (IMP) administration.Number of participants analyzed represents number of participants with data at each point.
Participants who have no effective data were excluded.
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Week1, Week4, Week8
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OPA-15406 Plasma PK Parameters, Cmax
Time Frame: Day 1 and Week 4
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OPA-15406 plasma PK parameter (Cmax) was measured on Day 1 and at Week 4 following topical administration of OPA-15406 0.3% and 1% ointment to adult subjects with AD.Number of participants analyzed represents number of participants with effective data at each point.
Participants who have no effective data were excluded.
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Day 1 and Week 4
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OPA-15406 Plasma PK Parameters, AUC8h
Time Frame: Day 1 and Week 4
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OPA-15406 plasma PK parameter (AUC8h) was measured on Day 1 and at Week 4 following topical administration of OPA-15406 0.3% and 1% ointment to adult subjects with AD.Number of participants analyzed represents number of participants with effective data at each point.
Participants who have no effective data were excluded.
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Day 1 and Week 4
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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
- 271-15-001
- JapicCTI-163372 (OTHER: 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.
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Otsuka Pharmaceutical Co., Ltd.Completed
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