Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Immune Technologies & Medicine GmbH.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Immune Technologies & Medicine GmbH
Information provided by:
Immune Technologies & Medicine GmbH
ClinicalTrials.gov Identifier:
NCT00824980
First received: January 16, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: IP10.C8 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis - Phase II Single Center Study |
Resource links provided by NLM:
Further study details as provided by Immune Technologies & Medicine GmbH:
Primary Outcome Measures:
- Psoriasis Area and Severity Index [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: IP10.C8 Gel |
Drug: IP10.C8
IP10.C8 Gel 1%
|
| Placebo Comparator: Placebo Gel |
Drug: IP10.C8
IP10.C8 Gel 1%
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00824980
Contacts
| Contact: Alexander Narvarini, M.D. | 41 (0)44 255 11 11 | alexander.navarini@usz.ch |
Locations
| Switzerland | |
| University Hospital Zurich | Recruiting |
| Zurich, Switzerland, 8091 | |
| Contact: Alexander Navarini, Dr.med. Dr.sc.nat. 41 (0)44 255 11 11 alexander.navarini@usz.ch | |
Sponsors and Collaborators
Immune Technologies & Medicine GmbH
Investigators
| Principal Investigator: | Lars E French, Prof. | University Hospital Zurich Department of Dermatology / Gloriastrasse 31 |
More Information
No publications provided
| Responsible Party: | Curdin Conrad, M.D., Dermatologische Klinik, Gloriastrasse 31, USZ, CH-8091 Zürich |
| ClinicalTrials.gov Identifier: | NCT00824980 History of Changes |
| Other Study ID Numbers: | IMTM_IP10.C8_II/1 |
| Study First Received: | January 16, 2009 |
| Last Updated: | January 16, 2009 |
| Health Authority: | Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013