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Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03018691
Recruitment Status : Completed
First Posted : January 12, 2017
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
To evaluate the safety, efficacy (dose response) and pharmacokinetics of 0.3% and 1% OPA-15406 when applied twice daily for 4 weeks in pediatric patients with atopic dermatitis.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: OPA-15406 Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: 0.3% OPA-15406 Ointments
Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.
Drug: OPA-15406
Experimental: 1% OPA-15406 Ointments
Subjects were treated with assigned 1% OPA-15406 ointment twice daily.
Drug: OPA-15406
Placebo Comparator: Placebo Ointments
Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Drug: Placebos



Primary Outcome Measures :
  1. The number of subjects experiencing AEs [ Time Frame: Week 0-4 ]
    The number of subjects experiencing AEs will be calculated for each treatment group.

  2. The percentage of subjects experiencing AEs [ Time Frame: Week 0-4 ]
    The percentage of subjects experiencing AEs will be calculated for each treatment group.


Secondary Outcome Measures :
  1. 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)

  2. Change from baseline in Eczema Area and Severity Index (EASI) [ Time Frame: Week 4 ]
  3. 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.



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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Japan
Hokkaido Region, Japan
Kanto Region, Japan
Kinki Region, Japan
Kyushu Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Hiroaki Ono, Mr Otsuka Pharmaceutical Co., Ltd.

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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03018691    
Other Study ID Numbers: 271-102-00002
JapicCTI-173484 ( Other Identifier: Japic )
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases