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

Primary Purpose

Plaque Psoriasis

Status
Unknown status
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Human recombinant epidermal growth factor
Placebo cream
Sponsored by
Ennar Pharmaceuticals AF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Zurich, Dermatology ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EGF Cream

Placebo cream

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in EGFR density in epidermis of psoriasis lesion
Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment, which is on day 66. EGFR immunohistochemistry will be performed with a murine antibody directed against the extracellular domain of human EGFR. A pathologist blinded to the patient's characteristics and treatment modalities assesses the immunohistochemistry staining in three epidermal layers. A score ranging form 0 (no staining) to 3 (intense staining) is applied, resulting in a total score ranging form 0 (3x0) to 9 (3x3).

Secondary Outcome Measures

Change to baseline in target lesion severity score (PASI)
A blinded dermatologist assesses the treated psoriasis plaque clinically using the lesion assessment part of the PASI score, assessing 3 qualities (thicknes, redness and scaling) of the lesion. Score ranges from 0 (absent) to 4 (very severe), resulting in a total score of 0 to 12 (3 x 4)
Change to baseline in histological feature: thickness of the epidermis
Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment on day 66. A pathologist blinded to the patient's characteristics and treatment modalities assesses the following histological features: thicknes of the epidermis, acanthosis and epidermal/dermal lymphocytic infiltrates. Each characteristic is scored as follows: 0 = normal, + = mild, and ++ = marked.
Number of participants with adverse events
At every visit the patients are asked about the occurence of adverse events. The last visit is on day 80. All adverse events will be recorded in the crf.
Change to baseline in the histological feature: acanthosis
Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment on day 66. A pathologist blinded to the patient's characteristics and treatment modalities assesses the following histological features: thicknes of the epidermis, acanthosis and epidermal/dermal lymphocytic infiltrates. Each characteristic is scored as follows: 0 = normal, + = mild, and ++ = marked.
Change to baseline in histological feature: epidermal/dermal lymphocytic infiltrates
Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment on day 66. A pathologist blinded to the patient's characteristics and treatment modalities assesses the following histological features: thicknes of the epidermis, acanthosis and epidermal/dermal lymphocytic infiltrates. Each characteristic is scored as follows: 0 = normal, + = mild, and ++ = marked.

Full Information

First Posted
March 21, 2012
Last Updated
August 2, 2012
Sponsor
Ennar Pharmaceuticals AF
Collaborators
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01566578
Brief Title
A Physiological Study on Downregulation of EGF-receptors in the Skin by Topical Exposition With EGF
Acronym
EGFR
Official Title
A Physiological Study on Downregulation of EGF-receptors in the Skin by Topical Exposition With EGF
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ennar Pharmaceuticals AF
Collaborators
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EGF Cream
Arm Type
Experimental
Arm Title
Placebo cream
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Human recombinant epidermal growth factor
Intervention Description
topical
Intervention Type
Other
Intervention Name(s)
Placebo cream
Intervention Description
Dermal cream without EGF
Primary Outcome Measure Information:
Title
Change from baseline in EGFR density in epidermis of psoriasis lesion
Description
Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment, which is on day 66. EGFR immunohistochemistry will be performed with a murine antibody directed against the extracellular domain of human EGFR. A pathologist blinded to the patient's characteristics and treatment modalities assesses the immunohistochemistry staining in three epidermal layers. A score ranging form 0 (no staining) to 3 (intense staining) is applied, resulting in a total score ranging form 0 (3x0) to 9 (3x3).
Time Frame
Day 66
Secondary Outcome Measure Information:
Title
Change to baseline in target lesion severity score (PASI)
Description
A blinded dermatologist assesses the treated psoriasis plaque clinically using the lesion assessment part of the PASI score, assessing 3 qualities (thicknes, redness and scaling) of the lesion. Score ranges from 0 (absent) to 4 (very severe), resulting in a total score of 0 to 12 (3 x 4)
Time Frame
Day 80
Title
Change to baseline in histological feature: thickness of the epidermis
Description
Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment on day 66. A pathologist blinded to the patient's characteristics and treatment modalities assesses the following histological features: thicknes of the epidermis, acanthosis and epidermal/dermal lymphocytic infiltrates. Each characteristic is scored as follows: 0 = normal, + = mild, and ++ = marked.
Time Frame
Day 66
Title
Number of participants with adverse events
Description
At every visit the patients are asked about the occurence of adverse events. The last visit is on day 80. All adverse events will be recorded in the crf.
Time Frame
Day 80
Title
Change to baseline in the histological feature: acanthosis
Description
Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment on day 66. A pathologist blinded to the patient's characteristics and treatment modalities assesses the following histological features: thicknes of the epidermis, acanthosis and epidermal/dermal lymphocytic infiltrates. Each characteristic is scored as follows: 0 = normal, + = mild, and ++ = marked.
Time Frame
Day 66
Title
Change to baseline in histological feature: epidermal/dermal lymphocytic infiltrates
Description
Punch biopsies of the treated psoriasis lesion will be performed before study treatment start (day 7) and at the end of the treatment on day 66. A pathologist blinded to the patient's characteristics and treatment modalities assesses the following histological features: thicknes of the epidermis, acanthosis and epidermal/dermal lymphocytic infiltrates. Each characteristic is scored as follows: 0 = normal, + = mild, and ++ = marked.
Time Frame
Day 66

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Weisskopf, MD
Email
michael.weisskopf@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Rudi Neirinckx, MD
Email
rudi_neirinckx@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kündig, MD
Organizational Affiliation
University Hospital Zurich, Dermatology Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Dermatology Clinic
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Weisskopf, MD
Email
michael.weisskopf@usz.ch
First Name & Middle Initial & Last Name & Degree
Michael Weisskopf, MD

12. IPD Sharing Statement

Learn more about this trial

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

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