- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03832751
Human Beta-defensin 1 in Vitiligo
February 5, 2019 updated by: Maha Fathy Elmasry, Cairo University
Estimation of Tissue Level of Human Beta-defensin 1 (HBD-1) in Vitiligo Before and After Narrowband UVB Phototherapy: a Case-control Study
There is a need to know the role of human beta defensin-1 in vitiligo pathogenesis and the probability of finding newer and effective therapy for vitiligo in the future.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Not Applicable
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 non-segmental vitiligo.
- Both genders.
- Age more than 18 years old.
- New cases or cases not receiving any treatment for at least 3 months prior to the study.
Exclusion Criteria:
- Universal or segmental vitiligo.
- Any contraindication to phototherapy treatment.
- History of autoimmune diseases or other systemic diseases.
- Any other skin disease.
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: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: vitiligo patients
Tissue levels of human beta-defensin 1 in vitiligo patients before and after NB-UVB phototherapy
|
skin biopsy before and after NB-UVB phototherapy to measure tissue human beta-defensin 1
|
|
Active Comparator: Healthy controls
Tissue levels of human beta-defensin 1 in healthy controls
|
skin biopsy before and after NB-UVB phototherapy to measure tissue human beta-defensin 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Tissue levels of human beta-defensin 1 before and after NB-UVB phototherapy
Time Frame: 6 months to 1 year
|
6 months to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 1, 2019
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
February 5, 2019
First Submitted That Met QC Criteria
February 5, 2019
First Posted (Actual)
February 6, 2019
Study Record Updates
Last Update Posted (Actual)
February 6, 2019
Last Update Submitted That Met QC Criteria
February 5, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dermatology 12
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.