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

This study is currently recruiting participants.
Verified August 2012 by Ennar Pharmaceuticals AF
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

March 21, 2012
August 2, 2012
April 2012
November 2012   (final data collection date for primary outcome measure)
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).

Same as current
Complete list of historical versions of study NCT01566578 on ClinicalTrials.gov Archive Site
  • 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.

Same as current
Not Provided
Not Provided
 
A Physiological Study on Downregulation of EGF-receptors in the Skin by Topical Exposition With EGF
A Physiological Study on Downregulation of EGF-receptors in the Skin by Topical Exposition With EGF

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Plaque Psoriasis
  • Drug: Human recombinant epidermal growth factor
    topical
  • Other: Placebo cream
    Dermal cream without EGF
  • Experimental: EGF Cream
    Intervention: Drug: Human recombinant epidermal growth factor
  • Placebo Comparator: Placebo cream
    Intervention: Other: Placebo cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 60 Years
No
Contact: Michael Weisskopf, MD michael.weisskopf@usz.ch
Contact: Rudi Neirinckx, MD rudi_neirinckx@hotmail.com
Switzerland
 
NCT01566578
EGFR-Study
No
Ennar Pharmaceuticals AF
Ennar Pharmaceuticals AF
University of Zurich
Principal Investigator: Thomas Kündig, MD University Hospital Zurich, Dermatology Clinic
Ennar Pharmaceuticals AF
August 2012

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