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 because the information has not been verified recently.
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
  Purpose

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


Condition Intervention Phase
Plaque Psoriasis
Drug: Human recombinant epidermal growth factor
Other: Placebo cream
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Physiological Study on Downregulation of EGF-receptors in the Skin by Topical Exposition With EGF

Resource links provided by NLM:


Further study details as provided by Ennar Pharmaceuticals AF:

Primary Outcome Measures:
  • Change from baseline in EGFR density in epidermis of psoriasis lesion [ Time Frame: Day 66 ] [ Designated as safety issue: No ]

    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:
  • Change to baseline in target lesion severity score (PASI) [ Time Frame: Day 80 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 24
Study Start Date: April 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EGF Cream Drug: Human recombinant epidermal growth factor
topical
Placebo Comparator: Placebo cream Other: Placebo cream
Dermal cream without EGF

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566578

Contacts
Contact: Michael Weisskopf, MD michael.weisskopf@usz.ch
Contact: Rudi Neirinckx, MD rudi_neirinckx@hotmail.com

Locations
Switzerland
University Hospital Zurich, Dermatology Clinic Recruiting
Zurich, Switzerland, 8091
Contact: Michael Weisskopf, MD       michael.weisskopf@usz.ch   
Sub-Investigator: Michael Weisskopf, MD         
Sponsors and Collaborators
Ennar Pharmaceuticals AF
University of Zurich
Investigators
Principal Investigator: Thomas Kündig, MD University Hospital Zurich, Dermatology Clinic
  More Information

No publications provided

Responsible Party: Ennar Pharmaceuticals AF
ClinicalTrials.gov Identifier: NCT01566578     History of Changes
Other Study ID Numbers: EGFR-Study
Study First Received: March 21, 2012
Last Updated: August 2, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014