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

Phase 1UnknownNCT01566578

Ennar Pharmaceuticals AF24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Plaque Psoriasis

Interventions

Human recombinant epidermal growth factorDRUG

topical

Placebo creamOTHER

Dermal cream without EGF

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Zurich, Dermatology Clinic

Zurich, Canton of Zurich, Switzerland

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: Day 66

Secondary Outcomes

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)

Time frame: 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.

Time frame: 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.

Time frame: Day 80

Change to baseline in the histological feature: acanthosis

Central Contacts

Michael Weisskopf, MD

CONTACT

michael.weisskopf@usz.ch

Rudi Neirinckx, MD

CONTACT

rudi_neirinckx@hotmail.com

Data from ClinicalTrials.gov

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