Status:
COMPLETED
Safety and Efficacy of SRD441 Ointment in Patients With Atopic Dermatitis
Lead Sponsor:
Serentis Ltd.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Atopic Dermatitis is a chronic inflammatory skin disease that affect 10 to 15% of children and 2 to 10% of adults. AD is characterised by an itchy skin eruption and may cover large parts of the body. ...
Eligibility Criteria
Inclusion
- Male and female subjects aged 18 or over
- Subjects with a history of AD
- Written and dated informed consent
- Satisfactory medical assessment with no clinical relevant abnormalities.
Exclusion
- Subjects with current or recurrent disease (except AD) that could affect the site of application, the action, absorption or disposition of the investigational product, or clinical or laboratory assessments.
- Subjects who have medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
- Subjects with any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible drug application sites which could impact the application of the test agent or confound the local assessments during this study.
- Subjects with clinically significant renal and liver parameters, as defined as greater than 1.5 x creatinine and 3 x AST ULN (upper limit of normal) respectively.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00882245
Start Date
April 1 2009
End Date
October 1 2009
Last Update
October 30 2009
Active Locations (12)
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1
Plovdiv, Bulgaria
2
Sofia, Bulgaria
3
Helsinki, Finland
4
Berlin, Germany