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

Phase 1

• Conditions: Plaque Psoriasis
• Interventions: Drug: Human recombinant epidermal growth factor; Other: Placebo cream

• Registration Number: NCT01566578
• Lead Sponsor: Ennar Pharmaceuticals AF

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-29
• Study Start: 2012-04
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-02
• Last Update Posted: 2012-08-03
• Primary Completion: 2012-11
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EGF Cream	Human recombinant epidermal growth factor	-
Placebo cream	Placebo cream	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital Zurich, Dermatology Clinic; 🇨🇭 Zurich, Switzerland