A Physiological Study on Downregulation of EGF-receptors in the Skin by Topical Exposition With EGF (EGFR)
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ClinicalTrials.gov Identifier: NCT01566578 |
Recruitment Status
: Unknown
Verified August 2012 by Ennar Pharmaceuticals AF.
Recruitment status was: Recruiting
First Posted
: March 29, 2012
Last Update Posted
: August 3, 2012
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Tracking Information | ||||
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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 |
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). |
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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 |
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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 |
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Condition ICMJE | Plaque Psoriasis | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |