Plaque Psoriasis
Conditions
Brief summary
Investigation of EGF-Receptor Downregulation by topical EGF (dermal cream) exposition.
Interventions
DRUGHuman recombinant epidermal growth factor
topical
OTHERPlacebo cream
Dermal cream without EGF
Sponsors
University of Zurich
Ennar Pharmaceuticals AF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in EGFR density in epidermis of psoriasis lesion | Day 66 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change to baseline in target lesion severity score (PASI) | Day 80 | 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 | Day 66 | 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 | Day 80 | 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 | Day 66 | 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 | Day 66 | 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. |
Countries
Switzerland
Contacts
Primary ContactMichael Weisskopf, MD
Backup ContactRudi Neirinckx, MD
Outcome results
None listed