Back to resultsSafety and Efficacy of SRD441 Ointment in Patients With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vehicle ointment
Ointment
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Vehicle ointment
SRD441 Ointment
Arm Description
Outcomes
Primary Outcome Measures
Measure efficacy in treating acute exacerbations
Secondary Outcome Measures
Safety and local dermal tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00882245
Brief Title
Safety and Efficacy of SRD441 Ointment in Patients With Atopic Dermatitis
Official Title
A Phase II, Double-Blind, Vehicle Controlled Study to Determine the Efficacy, Safety and Toleration of SRD441 Ointment in Patients With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Serentis Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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. The exact cause is unknown but is thought to be an interplay between genetic and and environmental factors. The objective of this study is to determine whether SRD441 ointment is a safe and effective therapy for mild to moderate Atopic Dermatitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vehicle ointment
Arm Type
Placebo Comparator
Arm Title
SRD441 Ointment
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Vehicle ointment
Intervention Description
Topical vehicle cream
Intervention Type
Drug
Intervention Name(s)
Ointment
Intervention Description
SRD441 Ointment
Primary Outcome Measure Information:
Title
Measure efficacy in treating acute exacerbations
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Safety and local dermal tolerability
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Tansley
Organizational Affiliation
Serentis Ltd.
Official's Role
Study Director
Facility Information:
City
Plovdiv
Country
Bulgaria
City
Sofia
Country
Bulgaria
City
Helsinki
Country
Finland
City
Berlin
Country
Germany
City
Bonn
Country
Germany
City
Cologne
Country
Germany
City
Frankfurt
Country
Germany
City
Hannover
Country
Germany
City
Heidelberg
Country
Germany
City
Kiel
Country
Germany
City
Munich
Country
Germany
City
Munster
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21039597
Citation
Foelster Holst R, Reitamo S, Yankova R, Worm M, Kadurina M, Thaci D, Bieber T, Tsankov N, Enk A, Luger T, Duffy M, Tansley R. The novel protease inhibitor SRD441 ointment is not effective in the treatment of adult subjects with atopic dermatitis: results of a randomized, vehicle-controlled study. Allergy. 2010 Dec;65(12):1594-9. doi: 10.1111/j.1398-9995.2010.02417.x. Epub 2010 Sep 7. Erratum In: Allergy. 2011 Feb;66(2):306. Thaci, K [corrected to Thaci, D].
Results Reference
derived
Learn more about this trial
Safety and Efficacy of SRD441 Ointment in Patients With Atopic Dermatitis
We'll reach out to this number within 24 hrs