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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2012 by Ennar Pharmaceuticals AF.
Recruitment status was: Recruiting

Sponsor:

Collaborator:

University of Zurich

Information provided by (Responsible Party):

Ennar Pharmaceuticals AF

ClinicalTrials.gov Identifier:

NCT01566578

First received: March 21, 2012

Last updated: August 2, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 21, 2012

Last Updated Date

August 2, 2012

Start Date ^ICMJE

April 2012

Estimated Primary Completion Date

November 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in EGFR density in epidermis of psoriasis lesion [ Time Frame: 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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01566578 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change to baseline in target lesion severity score (PASI) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Plaque Psoriasis

Intervention ^ICMJE

Drug: Human recombinant epidermal growth factor
topical
Other: Placebo cream
Dermal cream without EGF

Study Arms

Experimental: EGF Cream
Intervention: Drug: Human recombinant epidermal growth factor
Placebo Comparator: Placebo cream
Intervention: Other: Placebo cream

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2012

Estimated Primary Completion Date

November 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Male

Ages

18 Years to 60 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Switzerland

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01566578

Other Study ID Numbers ^ICMJE

EGFR-Study

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Ennar Pharmaceuticals AF

Study Sponsor ^ICMJE

Ennar Pharmaceuticals AF

Collaborators ^ICMJE

University of Zurich

Investigators ^ICMJE

Principal Investigator:

Thomas Kündig, MD

University Hospital Zurich, Dermatology Clinic

PRS Account

Ennar Pharmaceuticals AF

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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