- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05980390
IL35 Level in Vitiligo
August 7, 2023 updated by: Hagar El Sayed, Cairo University
Assessment of Tissue Levels of IL-35 in Active and Stable Vitiligo
The aim of this observational study is to evaluate the level of the IL-35 protein in tissue biopsy from patients with active & stable vitiligo.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
84
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
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Patients with active and stable vitiligo together with normal subjects
Description
Inclusion Criteria:
- Patients with active and stable vitiligo
Exclusion Criteria:
- Pregnant and lactating women.
- Patients with associated autoimmune or other dermatological diseases e.g., Alopecia areata and lupus erythematous.
- Patients already on both topical and systemic treatment at the time of recruitment.
- Patients on Immunosuppressive drugs.
- Other hypopigmented diseases such as pityriasis alba, tinea versicolor, lichen sclerosis, post inflammatory hypopigmentation and leprosy as excluded by lack of accentuation by wood's light examination.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Normal controls
|
Elisa testing
|
|
Active vitiligo
|
Elisa testing
|
|
Stable vitiligo
|
Elisa testing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
level of IL35 in tissue biopsy
Time Frame: 3 months
|
3 months
|
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 (Estimated)
August 10, 2023
Primary Completion (Estimated)
September 30, 2023
Study Completion (Estimated)
October 30, 2023
Study Registration Dates
First Submitted
July 29, 2023
First Submitted That Met QC Criteria
August 7, 2023
First Posted (Actual)
August 8, 2023
Study Record Updates
Last Update Posted (Actual)
August 8, 2023
Last Update Submitted That Met QC Criteria
August 7, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IL35 in vitiligo
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.