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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

January 16, 2009
January 16, 2009
January 2009
September 2009   (final data collection date for primary outcome measure)
Psoriasis Area and Severity Index [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis
Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis - Phase II Single Center Study

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
Drug: IP10.C8
IP10.C8 Gel 1%
  • Experimental: IP10.C8 Gel
    Intervention: Drug: IP10.C8
  • Placebo Comparator: Placebo Gel
    Intervention: Drug: IP10.C8
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: Alexander Narvarini, M.D. 41 (0)44 255 11 11 alexander.navarini@usz.ch
Switzerland
 
NCT00824980
IMTM_IP10.C8_II/1
No
Curdin Conrad, M.D., Dermatologische Klinik, Gloriastrasse 31, USZ, CH-8091 Zürich
Immune Technologies & Medicine GmbH
Not Provided
Principal Investigator: Lars E French, Prof. University Hospital Zurich Department of Dermatology / Gloriastrasse 31
Immune Technologies & Medicine GmbH
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP