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Study of OPA-15406 Ointment in Patients With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT02914548
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in patients with atopic dermatitis.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Assess the Efficacy and Safety of OPA-15406 Ointment in Patients With Atopic Dermatitis
Actual Study Start Date : September 2016
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
Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.
Drug: OPA-15406
Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.

Experimental: 1% OPA-15406
Subjects were treated with assigned 1% OPA-15406 ointment twice daily.
Drug: OPA-15406
Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.

Placebo Comparator: Placebo
Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
Drug: Placebo
Subjects were treated with assigned 0% OPA-15406 ointment twice daily.




Primary Outcome Measures :
  1. IGA response rate [ 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).


Secondary Outcome Measures :
  1. IGA response rate [ Time Frame: Week 1 and Week 8 ]
    Incidence of success in IGA at Week 1 and 8: 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 the total score of EASI [ Time Frame: Baseline, Week 1, Week 4, and Week 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
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): NCT02914548


Locations
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Japan
Hokkaido Region, Japan
Kanto Region, Japan
Kiniki 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: NCT02914548     History of Changes
Other Study ID Numbers: 271-15-001
JapicCTI-163372 ( Other Identifier: Japic )
First Posted: September 26, 2016    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