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

NCT01566578 | Unknown Phase 1

• 1 other identifier: EGFR-Study
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Change to baseline in target lesion severity score (PASI)

  Day 80

• Change to baseline in histological feature: thickness of the epidermis

  Day 66

• Number of participants with adverse events

  Day 80

• Change to baseline in the histological feature: acanthosis

  Day 66

• Change to baseline in histological feature: epidermal/dermal lymphocytic infiltrates

  Day 66

Study Arms (2)

EGF Cream

EXPERIMENTAL

Drug: Human recombinant epidermal growth factor

Placebo cream

PLACEBO COMPARATOR

Other: Placebo cream

Interventions

Human recombinant epidermal growth factor DRUG

topical

EGF Cream

Placebo cream OTHER

Dermal cream without EGF

Placebo cream

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ennar Pharmaceuticals AF: lead
• University of Zurich: collaborator

Study Sites (1)

University Hospital Zurich, Dermatology Clinic

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Study Officials

• Thomas Kündig, MD

  University Hospital Zurich, Dermatology Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Weisskopf, MD

CONTACT

michael.weisskopf@usz.ch

Rudi Neirinckx, MD

CONTACT

rudi_neirinckx@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: March 29, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: August 3, 2012

Record last verified: 2012-08

Locations

CH (1)