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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02068352
Registration number
NCT02068352
Ethics application status
Date submitted
19/02/2014
Date registered
21/02/2014
Date last updated
23/11/2021
Titles & IDs
Public title
A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis
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Scientific title
A Phase 2 Multi-center, Randomized, Double-blind, Vehicle-controlled, Three-arm, Parallel Group Study to Assess the Safety, Tolerability, and Efficacy of Topical OPA-15406 Ointment, in Subjects With Mild/Moderate Atopic Dermatitis
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Secondary ID [1]
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2013-003899-12
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Secondary ID [2]
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271-12-205
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - OPA-15406
Treatment: Drugs - Vehicle ointment
Experimental: 0.3% OPA-15406 - OPA-15406 0.3% ointment was applied topically twice daily (BID) to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
Experimental: 1% OPA-15406 - OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
Placebo Comparator: Vehicle Ointment - OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
Treatment: Drugs: OPA-15406
OPA-15406 topical ointment
Treatment: Drugs: Vehicle ointment
OPA-15406 1%-matching placebo topical ointment
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Success in the Overall Investigator's Global Assessment of Disease Severity (IGA) Score at Week 4 [Using Non-responder Imputation or Last Observation Carried Forward (LOCF)]
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Assessment method [1]
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The IGA evaluation was performed by a certified rater. The IGA score, used to assess the overall disease severity, consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. Success was defined as a score of 0 or 1 with at least a 2-grade reduction from Baseline. Participants without IGA score at Week 4 were treated as non-responders. In the sensitivity analysis, missing IGA score at Week 4 was imputed using LOCF method first and the success was defined based on the imputed IGA score.
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Timepoint [1]
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Week 4
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Secondary outcome [1]
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Change From Baseline in Overall IGA Score at Week 4 [Using Mixed Model Repeated Measures (MMRM) Analysis]
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Assessment method [1]
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The IGA evaluation was performed by a certified rater. The IGA allows for an assessment of overall disease severity at a given time point, and it consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. A negative change from Baseline indicates improvement in overall IGA score.
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Timepoint [1]
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Baseline, Week 4
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Secondary outcome [2]
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Change From Baseline in Overall IGA Score at Week 4 [Using Last Observation Carried Forward (LOCF) Analysis]
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Assessment method [2]
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The IGA allows for an assessment of overall disease severity at a given time point, and it consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. Missing overall IGA scores at Week 4 were imputed using LOCF method. A negative change from Baseline indicates improvement in overall IGA score.
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Timepoint [2]
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Baseline, Week 4
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Secondary outcome [3]
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Percentage of Participants With Adverse Events (AEs)
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Assessment method [3]
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An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An serious adverse event (SAE) was defined as any event which resulted in death, was life-threatening, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly/birth defect, or was another medically significant event.
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Timepoint [3]
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From signing of informed consent through Week 8
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Eligibility
Key inclusion criteria
- Participants 10-70 years of age
- Diagnosis of AD
- History of AD for at least 3 years
- AD affecting greater than or equal to 5% and less than or equal to 40% of total body
surface area (BSA) at Baseline
- Investigator's Global Assessment of Disease Severity score of 2 (mild) or 3 (moderate)
in the selected treatment area(s)
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Minimum age
10
Years
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Maximum age
70
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Contact or atopic dermatitis flare within 28 days of the Baseline (Day 1) visit.
- Concurrent diseases/conditions and history of other diseases/conditions in the
selected treatment area(s) that may have an impact on the study assessments.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/06/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/02/2015
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Sample size
Target
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Accrual to date
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Final
121
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA
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Recruitment hospital [1]
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- Phillip
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Recruitment hospital [2]
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- Kogarah
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Recruitment hospital [3]
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- Woolloongabba
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Recruitment hospital [4]
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- Hectorville
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Recruitment hospital [5]
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- Fremantle
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Recruitment postcode(s) [1]
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- Phillip
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Recruitment postcode(s) [2]
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- Kogarah
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Recruitment postcode(s) [3]
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- Woolloongabba
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Recruitment postcode(s) [4]
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5073 - Hectorville
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Recruitment postcode(s) [5]
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- Fremantle
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Recruitment outside Australia
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United States of America
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California
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Washington
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Poland
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Katowice
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Krakow
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Lodz
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Warsaw
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Wroclaw
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Otsuka Pharmaceutical Development & Commercialization, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to investigate the effectiveness and safety of 2 concentrations
of OPA-15406 compared to vehicle in participants with atopic dermatitis (AD).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02068352
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02068352
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