A Physiological Study on Downregulation of EGF-receptors in the Skin by Topical Exposition With EGF

NCT ID: NCT01566578

Last Updated: 2012-08-03

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

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-11-30

Brief Summary

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Investigation of EGF-Receptor Downregulation by topical EGF (dermal cream) exposition.

Detailed Description

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Conditions

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Plaque 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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EGF Cream

Group Type EXPERIMENTAL

Human recombinant epidermal growth factor

Intervention Type DRUG

topical

Placebo cream

Group Type PLACEBO_COMPARATOR

Placebo cream

Intervention Type OTHER

Dermal cream without EGF

Interventions

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Human recombinant epidermal growth factor

topical

Intervention Type DRUG

Placebo cream

Dermal cream without EGF

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Informed consent
* Mild to moderate psoriasis (all types) with active plaques on both body sides accessible for biopsy and self product application
* EGFR immunohistochemistry score \> 5
* Male
* Age 18-60 years

Exclusion Criteria

* Systemic psoriasis treatment 3 months prior and during the study
* Local psoriasis treatment on the investigational sites in the last 30 days or during the study
* Known hypersensitivity or allergy to the EGF containing product (Newskin) and/or to Vaseline/10% salicylic acid and/or to local anaesthetics of the amid type
* Known or suspected non-compliance to study protocol Coagulopathy or treatment with anticoagulants
* History of malignant disease Other clinically relevant concomitant disease state Participation in another investigational drug study in the last 30 days
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role collaborator

Ennar Pharmaceuticals AF

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Kündig, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Dermatology Clinic

Locations

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University Hospital Zurich, Dermatology Clinic

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Michael Weisskopf, MD

Role: CONTACT

Email: [email protected]

Rudi Neirinckx, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Michael Weisskopf, MD

Role: primary

Other Identifiers

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EGFR-Study

Identifier Type: -

Identifier Source: org_study_id