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

Ennar Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: Plaque Psoriasis

Treatments: Drug: Human recombinant epidermal growth factor; Other: Placebo cream

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01566578

EGFR-Study

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

EGF Cream

Experimental group

Treatment:

Drug: Human recombinant epidermal growth factor

Placebo cream

Placebo Comparator group

Treatment:

Other: Placebo cream