Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT03018691|
Recruitment Status : Completed
First Posted : January 12, 2017
Last Update Posted : July 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: OPA-15406 Drug: Placebos||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||January 2017|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
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.
- The number of subjects experiencing AEs [ Time Frame: Week 0-4 ]The number of subjects experiencing AEs will be calculated for each treatment group.
- The percentage of subjects experiencing AEs [ Time Frame: Week 0-4 ]The percentage of subjects experiencing AEs will be calculated for each treatment group.
- Investigator Global Assessment (IGA) response rate at week 4 [ Time Frame: Week 4 ]Incidence of success in IGA at Week 4: percentage of subjects with an IGA score of 0 or 1 with an improvement by at least 2 grades (responders)
- Change from baseline in Eczema Area and Severity Index (EASI) [ Time Frame: Week 4 ]
- Plasma concentration of OPA-15406 [ Time Frame: Week 1 and Week 4 ]The plasma concentration of OPA-15406 will be measured at Week 1 and Week 4. On the day of measurement, the subjects will visit the trial site without morning Investigational Medicinal Product (IMP) administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018691
|Hokkaido Region, Japan|
|Kanto Region, Japan|
|Kinki Region, Japan|
|Kyushu Region, Japan|
|Study Director:||Hiroaki Ono, Mr||Otsuka Pharmaceutical Co., Ltd.|