A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis

January 16, 2014 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in adult subjects with atopic dermatitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Hot Springs, Arizona, United States, 71913
    • California
      • Irvine, California, United States, 92697
    • Florida
      • Orange Park, Florida, United States, 32073
      • Tampa, Florida, United States, 33609
    • Indiana
      • Carmel, Indiana, United States, 46032
    • New Jersey
      • Berlin, New Jersey, United States, 08009
    • North Carolina
      • High Point, North Carolina, United States, 27262
    • Oregon
      • Portland, Oregon, United States, 97210
    • Texas
      • College Station, Texas, United States, 77845
      • Dallas, Texas, United States, 75230
      • San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo.
Drug: Placebo
Experimental: OPA-15406
Drug: OPA-15406
0.3%, 1%, or 3% OPA-15406 topical ointment, applied twice daily for 28 days
Active Comparator: Tacrolimus
Tacrolimus 0.1% ointment twice daily for 28 days.
Drug: Tacrolimus
0.1% concentration of tacrolimus.
Other Names:
  • Protopic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
28 days
Measurement of drug levels in the blood of treated patients
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Investigator's Global Assessment (IGA) of Disease Severity at Week 4
Time Frame: 28 Days
28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 4, 2012

First Posted (Estimate)

October 5, 2012

Study Record Updates

Last Update Posted (Estimate)

January 17, 2014

Last Update Submitted That Met QC Criteria

January 16, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 271-12-204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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