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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01702181
First received: October 3, 2012
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Atopic Dermatitis
Drug: OPA-15406
Drug: Tacrolimus
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

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. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Measurement of drug levels in the blood of treated patients [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigator's Global Assessment (IGA) of Disease Severity at Week 4 [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo.
Drug: Placebo
Active Comparator: Tacrolimus
Tacrolimus 0.1% ointment twice daily for 28 days.
Drug: Tacrolimus
0.1% concentration of tacrolimus.
Other Name: Protopic
Experimental: OPA-15406 Drug: OPA-15406
0.3%, 1%, or 3% OPA-15406 topical ointment, applied twice daily for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702181

Locations
United States, Alabama
Mobile, Alabama, United States, 36608
United States, Arizona
Hot Springs, Arizona, United States, 71913
United States, California
Irvine, California, United States, 92697
United States, Florida
Orange Park, Florida, United States, 32073
Tampa, Florida, United States, 33609
United States, Indiana
Carmel, Indiana, United States, 46032
United States, New Jersey
Berlin, New Jersey, United States, 08009
United States, North Carolina
High Point, North Carolina, United States, 27262
United States, Oregon
Portland, Oregon, United States, 97210
United States, Texas
College Station, Texas, United States, 77845
Dallas, Texas, United States, 75230
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01702181     History of Changes
Other Study ID Numbers: 271-12-204
Study First Received: October 3, 2012
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Atopic Dermatitis, Eczema

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014