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

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

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

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: Human recombinant epidermal growth factor
* Other: Placebo cream


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EGF Cream<br> | Drug: Human recombinant epidermal growth factor<br>* topical<br>|
| Placebo Comparator: Placebo cream<br> | Other: Placebo cream<br>* Dermal cream without EGF<br>|

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 |