Combined Inhibition of Dipeptidyl Peptidase IV (DPIV/CD26) and Aminopeptidase N (APN/CD13) in the Treatment of Psoriasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IP10.C8 Gel

Group Type EXPERIMENTAL

IP10.C8

Intervention Type DRUG

IP10.C8 Gel 1%

Placebo Gel

Group Type PLACEBO_COMPARATOR

IP10.C8

Intervention Type DRUG

IP10.C8 Gel 1%

Interventions

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IP10.C8

IP10.C8 Gel 1%

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No