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

Tracking Information
First Submitted Date ICMJE	March 21, 2012
First Posted Date ICMJE	March 29, 2012
Last Update Posted Date	August 3, 2012
Study Start Date ICMJE	April 2012
Estimated Primary Completion Date	November 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 27, 2012)	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; (submitted: March 27, 2012)	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; (submitted: March 27, 2012)	24
Original Estimated Enrollment ICMJE	Same as current
Estimated Study 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	No
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	No
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