A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis
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
1 other identifier
interventional
92
1 country
12
Brief Summary
The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in adult subjects with atopic dermatitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2012
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 3, 2012
CompletedFirst Posted
Study publicly available on registry
October 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 17, 2014
January 1, 2014
1.3 years
October 3, 2012
January 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of subjects with AEs, SAEs, and % of clinically relevant changes from baseline in Draize Scale, physical examinations, vital signs, laboratory assessments, and electrocardiograms.
28 days
Measurement of drug levels in the blood of treated patients
28 days
Secondary Outcomes (1)
Investigator's Global Assessment (IGA) of Disease Severity at Week 4
28 Days
Study Arms (3)
Placebo
PLACEBO COMPARATORMatching placebo.
Tacrolimus
ACTIVE COMPARATORTacrolimus 0.1% ointment twice daily for 28 days.
OPA-15406
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Use of systemic or topical therapy for contact or atopic dermatitis within 30 days of screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Hot Springs, Arizona, 71913, United States
Unknown Facility
Irvine, California, 92697, United States
Unknown Facility
Orange Park, Florida, 32073, United States
Unknown Facility
Tampa, Florida, 33609, United States
Unknown Facility
Carmel, Indiana, 46032, United States
Unknown Facility
Berlin, New Jersey, 08009, United States
Unknown Facility
High Point, North Carolina, 27262, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
College Station, Texas, 77845, United States
Unknown Facility
Dallas, Texas, 75230, United States
Unknown Facility
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2012
First Posted
October 5, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
January 17, 2014
Record last verified: 2014-01