Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis
1 other identifier
interventional
24
1 country
1
Brief Summary
The major objective of this study is to evaluate the therapeutic effect of a topical treatment simultaneously inhibiting Dipeptidyl Peptidase IV and Aminopeptidase N (IMTM #IP10.C8) in patients with mild to moderate psoriasis of the skin
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 16, 2009
CompletedFirst Posted
Study publicly available on registry
January 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedJanuary 19, 2009
January 1, 2009
8 months
January 16, 2009
January 16, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Psoriasis Area and Severity Index
4 weeks
Study Arms (2)
IP10.C8 Gel
EXPERIMENTALPlacebo Gel
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age 18 years of age at pre-study and
- Diagnosis of plaque type psoriasis at least 3 month prior to enrolment
- Mild to moderate plaque type psoriasis with at least 2 plaques of approximately 15cm2 for which topical treatment is indicated
- Patients must be able to give written informed consent before any trial-specific procedures are performed (see Section 12.2
You may not qualify if:
- Other type of psoriasis (e.g. erythrodermic, guttate or pustular) at enrolment
- Drug induced psoriasis at enrolment (e.g. lithium)
- Pregnant or lactating women, patients (men or women) planning a pregnancy during the duration of the study
- Systemic therapy affecting PASI or phototherapy for a period of 4 weeks prior to enrolment
- Topical therapy affecting PASI for a period of 2 weeks prior to enrolment
- Treatment with biologic agents affecting PASI for a period of 3 months prior to enrolment
- Systemic treatment with immunosuppressive agents (e.g. methotrexate, cyclosporin) or treatment with lithium, anti-malaria medication, or intramuscular gold application for a period of 4 weeks prior to enrolment
- Having a history of or an ongoing uncontrolled serious or recurring bacterial, viral, fungal, or atypical mycobacterial infection
- Having a severe medical condition that, in the judgment of the investigator, would jeopardize in any way the subject's safety following exposure to study drug
- Having the presence or history of malignancy, including lymphoproliferative disorders. Subjects with a history of fully resolved basal or squamous cell skin cancer may be enrolled
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich
Zurich, 8091, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lars E French, Prof.
University Hospital Zurich Department of Dermatology / Gloriastrasse 31
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 16, 2009
First Posted
January 19, 2009
Study Start
January 1, 2009
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
January 19, 2009
Record last verified: 2009-01