- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03377998
Expression of Erythroid Differentiation Regulator 1 (Erdr1) in Vitiligo
December 14, 2017 updated by: Maha Fathy Elmasry, Cairo University
Expression of Erythroid Differentiation Regulator 1 (Erdr1) Cytokine in the Vitiliginous Skin Lesions: a Case Control Study
Expression of Erythroid differentiation regulator 1 (Erdr1) cytokine in vitiligo
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with generalized non-segmental vitiligo.
- Both sexes.
- Age >18 years old.
- New cases or cases not receiving any medication for at least 3 months ago.
Exclusion Criteria:
- Segmental or Universal vitiligo
- Autoimmune diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: vitiligo patients
lesional skin biopsy to measure ERDR1 level
|
Skin biopsy for measuring tissue levels of the Erythroid differentiation regulator 1 (Erdr1) cytokine will be taken from the lesional skin of patients of vitiligo and from normal skin of healthy controls.
|
Experimental: controls
normal skin biopsy to measure ERDR1 level
|
Skin biopsy for measuring tissue levels of the Erythroid differentiation regulator 1 (Erdr1) cytokine will be taken from the lesional skin of patients of vitiligo and from normal skin of healthy controls.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Expression of tissue levels of erythroid differentiation regulator 1 (Erdr1) cytokine in patients of vitiligo
Time Frame: 6 months
|
Expression of tissue levels of erythroid differentiation regulator 1 (Erdr1) cytokine in patients of vitiligo and comparing its level in normal subjects
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maha Elmasry, MD, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2018
Primary Completion (Anticipated)
July 1, 2018
Study Completion (Anticipated)
July 1, 2018
Study Registration Dates
First Submitted
December 11, 2017
First Submitted That Met QC Criteria
December 14, 2017
First Posted (Actual)
December 19, 2017
Study Record Updates
Last Update Posted (Actual)
December 19, 2017
Last Update Submitted That Met QC Criteria
December 14, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- Dermatology 4
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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