Status:
COMPLETED
Phase IIa Safety and Efficacy Study of SRD174 Cream in Patients With AD-associated Pruritus
Lead Sponsor:
Serentis Ltd.
Conditions:
Pruritus, Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00838708
Start Date
January 1 2009
End Date
August 1 2009
Last Update
October 30 2009
Active Locations (13)
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1
Birmingham, Alabama, United States
2
Hot Springs, Arkansas, United States
3
Oceanside, California, United States
4
Ormond Beach, Florida, United States