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

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

Study Overview

• Status: Unknown
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Human recombinant epidermal growth factor; Other: Placebo cream

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Michael Weisskopf, MD; Email: michael.weisskopf@usz.ch
• Study Contact Backup: Name: Rudi Neirinckx, MD; Email: rudi_neirinckx@hotmail.com

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Recruiting
    • University Hospital Zurich, Dermatology Clinic
    • Contact: Michael Weisskopf, MD; Email: michael.weisskopf@usz.ch
    • Sub-Investigator: Michael Weisskopf, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EGF Cream	Drug: Human recombinant epidermal growth factor; topical
PLACEBO_COMPARATOR: Placebo cream	Other: Placebo cream; Dermal cream without EGF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 66

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Day 80
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.	Day 66
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.	Day 80
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.	Day 66
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.	Day 66

Collaborators and Investigators

• Sponsor: Ennar Pharmaceuticals AF
• Collaborators: University of Zurich
• Investigators: Principal Investigator: Thomas Kündig, MD, University Hospital Zurich, Dermatology Clinic

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ANTICIPATED): November 1, 2012
• Study Completion (ANTICIPATED): November 1, 2012

Study Registration Dates

• First Submitted: March 21, 2012
• First Submitted That Met QC Criteria: March 27, 2012
• First Posted (ESTIMATE): March 29, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 3, 2012
• Last Update Submitted That Met QC Criteria: August 2, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: EGFR-Study