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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03018691 |
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Date of registration:
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06/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis
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Scientific title:
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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 |
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Date of first enrolment:
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January 2017 |
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Target sample size:
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73 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03018691 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hiroaki Ono, Mr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Otsuka Pharmaceutical Co., Ltd. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
2 Years
Age maximum:
14 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Atopic Dermatitis
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Intervention(s)
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Drug: OPA-15406
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Drug: Placebos
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Primary Outcome(s)
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The Number of Subjects Experiencing AEs
[Time Frame: Week 0-4]
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Secondary Outcome(s)
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Responder Rate of Investigator's Global Assessment(IGA) of Disease Severity at Week4
[Time Frame: Baseline and 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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Change From Baseline in Visual Analogue Scale(VAS) for Pruritus Score
[Time Frame: Baseline, Week 4]
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Mean (SD) Normalized OPA-15406 Plasma Trough Concentrations by Dose Derived From %BSA at week1
[Time Frame: week1]
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Mean (SD) Normalized OPA-15406 Plasma Trough Concentrations by Dose Derived From %BSA at week4
[Time Frame: week4]
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Change From Baseline in Patient-Oriented Eczema Measure(POEM) Score
[Time Frame: Baseline, Week 4]
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Change From Baseline in Percentage Affected Body Surface Area
[Time Frame: Baseline, Week 8, 16, 24]
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Mean (SD) OPA-15406 Plasma Trough Concentrations at week1
[Time Frame: Week 1]
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Mean (SD) OPA-15406 Plasma Trough Concentrations at week4
[Time Frame: week4]
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Change From Baseline in Verbal Rating Scale(VRS) for Pruritus Score
[Time Frame: Baseline, Hour 156]
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Secondary ID(s)
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JapicCTI-173484
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271-102-00002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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