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
Sponsor:
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
  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:

  1. Age 18 years of age at pre-study and
  2. Diagnosis of plaque type psoriasis at least 3 month prior to enrolment
  3. Mild to moderate plaque type psoriasis with at least 2 plaques of approximately 15cm2 for which topical treatment is indicated
  4. Patients must be able to give written informed consent before any trial-specific procedures are performed (see Section 12.2

Exclusion Criteria:

  1. Other type of psoriasis (e.g. erythrodermic, guttate or pustular) at enrolment
  2. Drug induced psoriasis at enrolment (e.g. lithium)
  3. Pregnant or lactating women, patients (men or women) planning a pregnancy during the duration of the study
  4. Systemic therapy affecting PASI or phototherapy for a period of 4 weeks prior to enrolment
  5. Topical therapy affecting PASI for a period of 2 weeks prior to enrolment
  6. Treatment with biologic agents affecting PASI for a period of 3 months prior to enrolment
  7. 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
  8. Having a history of or an ongoing uncontrolled serious or recurring bacterial, viral, fungal, or atypical mycobacterial infection
  9. 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
  10. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014