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IL35 Level in Vitiligo

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ClinicalTrials.gov Identifier: NCT05980390
Recruitment Status : Not yet recruiting
First Posted : August 8, 2023
Last Update Posted : August 8, 2023
Sponsor:
Information provided by (Responsible Party):
Hagar El Sayed, Cairo University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
IL35, Vitiligo Diagnostic Test: IL 35 in tissue biopsy

Study Design
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Study Type : Observational
Estimated Enrollment : 84 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Assessment of Tissue Levels of IL-35 in Active and Stable Vitiligo
Estimated Study Start Date : August 10, 2023
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Biopsy Vitiligo

Groups and Cohorts
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Group/Cohort Intervention/treatment
Active vitiligo Diagnostic Test: IL 35 in tissue biopsy
Elisa testing
Stable vitiligo Diagnostic Test: IL 35 in tissue biopsy
Elisa testing
Normal controls Diagnostic Test: IL 35 in tissue biopsy
Elisa testing


Outcome Measures
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Primary Outcome Measures :
  1. level of IL35 in tissue biopsy [ Time Frame: 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with active and stable vitiligo together with normal subjects
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Hagar El Sayed, Dr, Cairo University
ClinicalTrials.gov Identifier: NCT05980390    
Other Study ID Numbers: IL35 in vitiligo
First Posted: August 8, 2023    Key Record Dates
Last Update Posted: August 8, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases