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| Name | Class |
|---|---|
| University of Zurich | OTHER |
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Investigation of EGF-Receptor Downregulation by topical EGF (dermal cream) exposition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGF Cream | Experimental |
| |
| Placebo cream | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human recombinant epidermal growth factor | Drug | topical |
| |
| Placebo cream |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Weisskopf, MD | Contact | michael.weisskopf@usz.ch | ||
| Rudi Neirinckx, MD | Contact | rudi_neirinckx@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Kündig, MD | University Hospital Zurich, Dermatology Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Dermatology Clinic | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
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| Other |
Dermal cream without EGF |
|
| 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 |