Phase IIa Safety and Efficacy Study of SRD174 Cream in Patients With AD-associated Pruritus
NCT ID: NCT00838708
Last Updated: 2009-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2009-01-31
2009-08-31
Brief Summary
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The objective of this study is to determine whether SRD174 Cream is a safe and effective therapy for moderate to severe pruritus associated with atopic dermatitis.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Vehicle cream
vehicle cream
topical vehicle cream
SRD174 Cream
SRD174 Cream
topical SRD174 Cream
Interventions
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SRD174 Cream
topical SRD174 Cream
vehicle cream
topical vehicle cream
Eligibility Criteria
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Inclusion Criteria
* Written signed and dated informed consent
* Satisfactory medical assessment with no clinically relevant abnormalities
Exclusion Criteria
* Subject with severe AD defined as an IGA score of 4
* Subject with current or recurrent skin disease (except AD) that could affect the site of application of action, absorption or disposition of the investigational product, or clinical, laboratory assessments.
* Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
* Subject with known or suspected intolerance or hypersensitivity to the Investigational products or any of the stated ingredients.
* Subject who has a medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with interpretation of trial results and, in the judgment if the investigator, would make the subject inappropriate for entry into this trial.
18 Years
ALL
No
Sponsors
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Serentis Ltd.
INDUSTRY
Responsible Party
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Serentis
Locations
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Birmingham, Alabama, United States
Hot Springs, Arkansas, United States
Oceanside, California, United States
Ormond Beach, Florida, United States
Detroit, Michigan, United States
Grand Blanc, Michigan, United States
High Point, North Carolina, United States
Winston-Salem, North Carolina, United States
Hazleton, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
Lynchburg, Virginia, United States
Spokane, Washington, United States
Countries
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Other Identifiers
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P174954201CD
Identifier Type: -
Identifier Source: org_study_id