- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00838708
Phase IIa Safety and Efficacy Study of SRD174 Cream in Patients With AD-associated Pruritus
A Phase II, Randomised, Double-blind, Vehicle-controlled, Cross-over Study to Determine the Anti-pruritic Efficacy, Safety and Local Dermal Toleration of SRD174 Cream in Subjects With Atopic Dermatitis.
Pruritus is an essential feature for the diagnosis of atopic dermatitis and may play an important part in disease progression. Itching has a significant impact on the quality of life of AD sufferers, in particular night-time itching leading to sleep disturbance and subsequent poor daytime performance.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States
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Arkansas
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Hot Springs, Arkansas, United States
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California
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Oceanside, California, United States
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Florida
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Ormond Beach, Florida, United States
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Michigan
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Detroit, Michigan, United States
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Grand Blanc, Michigan, United States
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North Carolina
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High Point, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Pennsylvania
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Hazleton, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Texas
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Dallas, Texas, United States
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Virginia
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Lynchburg, Virginia, United States
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Washington
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Spokane, Washington, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males and females aged 18 years and over moderate to severe AD pruritus
- Written signed and dated informed consent
- Satisfactory medical assessment with no clinically relevant abnormalities
Exclusion Criteria:
- Subject with active and pruritic AD covering a body surface area (BSA) > 20%
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Vehicle cream
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topical vehicle cream
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Experimental: SRD174 Cream
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topical SRD174 Cream
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Measure of intensity and duration of itch episodes
Time Frame: Duration of episode
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Duration of episode
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and local dermal tolerability
Time Frame: 4 weeks
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4 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P174954201CD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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