Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)
NCT ID: NCT00914186
Last Updated: 2011-12-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
122 participants
INTERVENTIONAL
2009-06-30
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Vehicle
Vehicle
Lotion
TS-022 0.005% lotion
TS022
Lotion
TS-022 0.010% lotion
TS022
Lotion
TS-022 0.020% lotion
TS022
Lotion
Interventions
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TS022
Lotion
Vehicle
Lotion
Eligibility Criteria
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Inclusion Criteria
2. Generally healthy subjects, who have no past or present history of any significant and/or newly-diagnosed disease or condition
3. A score of 2 (Mild Disease), 3 (Moderate Disease) or 4 (Severe Disease) on the Investigator's Global Assessment of Atopic Dermatitis (IGA) Scale
4. A score of 2 (Moderate Pruritus), 3 (Severe Pruritus) or 4 (Very Severe Pruritus) on the Five-Point Pruritus Scale
5. Patient satisfies the diagnostic criteria for AD as determined by the criteria of Hanifin and Rajka
6. Patient understands the study procedures and agrees to participate in the study by giving written Informed Consent
7. Ability to read and understand English and to provide written informed consent and authorization for protected health information disclosure
Exclusion Criteria
2. Use of phototherapy, including exposure to tanning beds, within 28 days of Study Drug application
3. 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
4. Females who are planning a pregnancy, who are pregnant, or who are breastfeeding
5. Inability or unwillingness to discontinue current AD treatment(s)
6. Inability or unwillingness to comply with study visit schedule and/or other study activities as required by the study protocol
18 Years
65 Years
ALL
No
Sponsors
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Taisho Pharmaceutical R&D Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nermina Nakas, MD
Role: STUDY_DIRECTOR
Clinsys
Locations
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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
Countries
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Other Identifiers
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TS022-US201
Identifier Type: -
Identifier Source: org_study_id