Back to resultsA Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
OPA-15406
Tacrolimus
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Eczema
Eligibility Criteria
Inclusion Criteria:
- Adult subjects 18-65 years of age
- Diagnosis of atopic dermatitis (AD)
- AD affecting at least 5% of total Body Surface Area (BSA) for Part 1 and at least 10% BSA for Part 2, not including face, neck, and head
- Have had a positive but inadequate response to one or more treatment course of standard AD therapy including topical steroids, UV light A, narrowband UV B, and UV light B.
Exclusion Criteria:
-Use of systemic or topical therapy for contact or atopic dermatitis within 30 days of screening
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
Placebo
Tacrolimus
OPA-15406
Arm Description
Matching placebo.
Tacrolimus 0.1% ointment twice daily for 28 days.
Outcomes
Primary Outcome Measures
Number of subjects with AEs, SAEs, and % of clinically relevant changes from baseline in Draize Scale, physical examinations, vital signs, laboratory assessments, and electrocardiograms.
Measurement of drug levels in the blood of treated patients
Secondary Outcome Measures
Investigator's Global Assessment (IGA) of Disease Severity at Week 4
Full Information
NCT ID
NCT01702181
First Posted
October 3, 2012
Last Updated
January 16, 2014
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01702181
Brief Title
A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis
Official Title
A Multiple-Dose (0.3%, 1%, and 3% [w/w]), Randomized, Blinded, Vehicle- and Active Comparator-Controlled, Sequential Dose Cohorts, Multi-Center Trial to Assess the Safety, Pharmacokinetics, and Proof-of-Concept Efficacy of Topical OPA 15406 Ointment, Applied Twice Daily for 28 Days, in Adult Subjects With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in adult subjects with atopic dermatitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, Eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo.
Arm Title
Tacrolimus
Arm Type
Active Comparator
Arm Description
Tacrolimus 0.1% ointment twice daily for 28 days.
Arm Title
OPA-15406
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
OPA-15406
Intervention Description
0.3%, 1%, or 3% OPA-15406 topical ointment, applied twice daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
Protopic
Intervention Description
0.1% concentration of tacrolimus.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of subjects with AEs, SAEs, and % of clinically relevant changes from baseline in Draize Scale, physical examinations, vital signs, laboratory assessments, and electrocardiograms.
Time Frame
28 days
Title
Measurement of drug levels in the blood of treated patients
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Investigator's Global Assessment (IGA) of Disease Severity at Week 4
Time Frame
28 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult subjects 18-65 years of age
Diagnosis of atopic dermatitis (AD)
AD affecting at least 5% of total Body Surface Area (BSA) for Part 1 and at least 10% BSA for Part 2, not including face, neck, and head
Have had a positive but inadequate response to one or more treatment course of standard AD therapy including topical steroids, UV light A, narrowband UV B, and UV light B.
Exclusion Criteria:
-Use of systemic or topical therapy for contact or atopic dermatitis within 30 days of screening
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Hot Springs
State/Province
Arizona
ZIP/Postal Code
71913
Country
United States
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis
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