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OpenTrials
Completed

NCT Number: NCT01702181

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

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPA-15406

Drug

0.3%, 1%, or 3% OPA-15406 topical ointment, applied twice daily for 28 days

Tacrolimus

Drug

0.1% concentration of tacrolimus.

Other names: Protopic

Placebo

Drug

Primary outcomes

  1. 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

  2. Measurement of drug levels in the blood of treated patients

    Time frame: 28 days

Secondary outcomes

  1. Investigator's Global Assessment (IGA) of Disease Severity at Week 4

    Time frame: 28 Days

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 5, 2012
Registry last updated
Jan 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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