Back to resultsExpression of LC3-I, LC3-II & Beclin 1 in Vitiligo
Primary Purpose
Autophagy
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
skin biopsy
Sponsored by
About this trial
This is an interventional basic science trial for Autophagy
Eligibility Criteria
Inclusion Criteria:
• Patients with non-segmental vitiligo whether active or stable.
- Age above 12 years.
- Both sexes.
Exclusion Criteria:
• Patients should not use any topical or systemic treatment at least 6 weeks before inclusion into the study.
- Patients having other autoimmune disease, heart disease, liver disease, kidney disease, neurological disorder, cancer, active infection or any chronic disease.
- Pregnancy or breast feeding for female patients.
Sites / Locations
- Maha Fathy ElmasryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
vitiligo patients
healthy controls
Arm Description
Outcomes
Primary Outcome Measures
Expression of LC3-I, LC3-II & Beclin 1 in vitiligo patients
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03371758
Brief Title
Expression of LC3-I, LC3-II & Beclin 1 in Vitiligo
Official Title
Expression of LC3-I, LC3-II & Beclin 1 in Vitiligo and Healthy Control; Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The exact mechanism of impairment of autophagy in vitiligo has not yet been determined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autophagy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vitiligo patients
Arm Type
Experimental
Arm Title
healthy controls
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
skin biopsy
Intervention Description
Punch skin biopsy will be taken from the lesional and non-lesional skin of vitiligo patients as well as healthy skin of controls.
Primary Outcome Measure Information:
Title
Expression of LC3-I, LC3-II & Beclin 1 in vitiligo patients
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• Patients with non-segmental vitiligo whether active or stable.
Age above 12 years.
Both sexes.
Exclusion Criteria:
• Patients should not use any topical or systemic treatment at least 6 weeks before inclusion into the study.
Patients having other autoimmune disease, heart disease, liver disease, kidney disease, neurological disorder, cancer, active infection or any chronic disease.
Pregnancy or breast feeding for female patients.
Facility Information:
Facility Name
Maha Fathy Elmasry
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maha Fathy Elmasry, MD
Email
mahafathy1214@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Expression of LC3-I, LC3-II & Beclin 1 in Vitiligo
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