Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)

Completed · Phase 2

Conditions studied: Atopic Dermatitis

In brief

The purpose and (primary) objectives of this study are to evaluate the efficacy, safety, and tolerability of TS-022 in adults with atopic dermatitis who have moderate to very severe pruritus (itching), following a 28-day regimen of twice-daily topical application.

Key facts

Study ID

NCT00914186

Run by

Taisho Pharmaceutical R&D Inc.

People needed

122

Starts

2009-06-01

Expected to finish

2010-10-01

Last updated by the study team

2011-12-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults, males or females, 18 - 65 years of age at the time of obtaining the written Informed Consent
• Generally healthy subjects, who have no past or present history of any significant and/or newly-diagnosed disease or condition
• A score of 2 (Mild Disease), 3 (Moderate Disease) or 4 (Severe Disease) on the Investigator's Global Assessment of Atopic Dermatitis (IGA) Scale
• A score of 2 (Moderate Pruritus), 3 (Severe Pruritus) or 4 (Very Severe Pruritus) on the Five-Point Pruritus Scale
• Patient satisfies the diagnostic criteria for AD as determined by the criteria of Hanifin and Rajka
• Patient understands the study procedures and agrees to participate in the study by giving written Informed Consent
• Ability to read and understand English and to provide written informed consent and authorization for protected health information disclosure

You may not qualify if…

• Concurrent skin pathology or recent history (within the past 5 years) of a chronic skin disease other than AD
• Use of phototherapy, including exposure to tanning beds, within 28 days of Study Drug application
• Taking systemic immunosuppressive drugs, biologicals, or corticosteroids therapy within (14 days), or topical immunosuppressive drugs or corticosteroid therapy (within 7 days) of Study Drug application
• Females who are planning a pregnancy, who are pregnant, or who are breastfeeding
• Inability or unwillingness to discontinue current AD treatment(s)
• Inability or unwillingness to comply with study visit schedule and/or other study activities as required by the study protocol

Where it is running

• UCSD — La Jolla, California, United States
• Therapeutics Clinical Research — San Diego, California, United States
• Ameriderm Research — Jacksonville, Florida, United States
• Ameriderm Research — Kissimmee, Florida, United States
• FXM Research — Miramar, Florida, United States
• Ameriderm Research — Ormond Beach, Florida, United States
• Gwinnett Clinical Research — Snellville, Georgia, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Comprehensive Clinical Research — Berlin, New Jersey, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Haber Dermatology and Cosmetic Surgery, Inc — South Euclid, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• J & S Studies — College Station, Texas, United States
• Center for Clinical Studies — Houston, Texas, United States
• Center for Clinical Studies — Webster, Texas, United States

Full record on ClinicalTrials.gov

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