Effect of NB-UVB on the Tissue Level of IL 15 and IL-15Rα in Active Non Segmental Vitiligo Cases.

NCT05316987 | Completed

• 1 other identifier: MS_ 270_2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at evaluating the effect of NB-UVB on tissue level of IL-15 and IL-15 receptor alpha subunit (IL-15Rα)(CD215) in active non segmental vitiligo. This in turn will shed light on the potential role of phototherapy as a safe mean of prevention of vitiligo recurrence as well as evaluating the utility of IL 15 and IL 15 Rα as markers of vitiligo activity/recurrence.

Conditions

Active Non Segmental Vitiligo

Outcome Measures

Primary Outcomes (1)

• Effect of NB-UVB on tissue level of IL 15 and IL15Rα in active vitiligo

  Change of tissue level of Il-15 and IL-15Rα after 48 session of NB-UVB

  4 month

Secondary Outcomes (2)

• Effect of activity of vitiligo on tissue level of Il-15 and IL-15Rα

  4 months

• Effect of extent of vitiligo on tissue level of Il-15 and IL-15Rα

  4 month

Study Arms (1)

Active vitiligo patients

OTHER

NBUVB

Radiation: Narrow band ultraviolet B

Interventions

Narrow band ultraviolet B RADIATION

48 sessions of narrow band ultraviolet

Active vitiligo patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥ 18 years.
• Both genders.
• Type of Vitiligo: non segmental vitiligo (NSV).
• Active disease for less than 6 months (VIDA ≥ +2).
• No systemic or topical treatment for vitiligo for at least one month.

You may not qualify if:

• Patients less than 18 years.
• VIDA ≤ +1.
• Contraindications to phototherapy (precancerous conditions like
• Xeroderma pigmentosum , photosensitivity, history of arsenic intake,
• ionizing radiation, extensive previous exposure to PUVA, patients
• with a history of melanoma, atypical nevi, non-melanoma skin
• cancers and patients taking immunosuppressive medications ( Menter et al., 2010 and Mehta \& Lim, 2016).
• Pregnancy and lactation .
• Patients who received systemic or topical treatment for the past
• month.
• patients having any autoimmune diseases .

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Nourhan Emad

Cairo, Helwan, Egypt

Location

Study Officials

• Nourhan Emad

  Faculty of medicine kasr Elainy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: April 7, 2022
• Study Start: April 30, 2022
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 month and ending 12 month after article publication
• Access Criteria: Researchers who provide a methodologically sound proposal will be allowed to access the data to achieve aims in the approved proposal Proposal should be directed to nourhanemad693@gmail.com to gain access

Locations

EG (1)