A Physiological Study on Downregulation of EGF-receptors in the Skin by Topical Exposition With EGF (EGFR)
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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 |
- 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).
- 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 |
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| Contact: Michael Weisskopf, MD | michael.weisskopf@usz.ch | |
| Contact: Rudi Neirinckx, MD | rudi_neirinckx@hotmail.com |
| Switzerland | |
| University Hospital Zurich, Dermatology Clinic | Recruiting |
| Zurich, Switzerland, 8091 | |
| Contact: Michael Weisskopf, MD michael.weisskopf@usz.ch | |
| Sub-Investigator: Michael Weisskopf, MD | |
| 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:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Mitogens |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013