Status:
COMPLETED
Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)
Lead Sponsor:
Taisho Pharmaceutical R&D Inc.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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)...
Detailed Description
(none provided)
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00914186
Start Date
June 1 2009
End Date
October 1 2010
Last Update
December 1 2011
Active Locations (15)
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1
UCSD
La Jolla, California, United States, 92037
2
Therapeutics Clinical Research
San Diego, California, United States, 92123
3
Ameriderm Research
Jacksonville, Florida, United States, 32216
4
Ameriderm Research
Kissimmee, Florida, United States, 34741