AzTrials
AzTrials

Active Non Segmental VitiligoNCT05316987

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

A study testing Narrow band ultraviolet B in people with Active Non Segmental Vitiligo, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Active Non Segmental Vitiligo
What is being tested?
Narrow band ultraviolet B
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
30 Apr 2022to 30 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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 .

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Nourhan Emad

    Cairo, Helwan

Other trials in Egypt

About this study

Official title: Effect of Narrow Band Ultraviolet B on the Tissue Level of Interleukin 15 and Interleukin 15 Receptor Alpha Subunit in Active Non Segmental Vitiligo Cases.

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.

Read the detailed description

Vitiligo is a T cell-mediated, autoimmune cutaneous disorder characterized by loss of functioning melanocytes from the basal layer of epidermis and/or hair follicles, leading to depigmented areas of the skin, mucous membranes, and/or hair (Strassner et al., 2018).

Multiple factors have been involved in disease development, with a prominent role of the immune system, in particular T cells. After repigmentation, vitiligo usually recurs in the same area, drawing attention to the fact that resident memory T cells (TRM) are present at the sites of vitiligo lesions. This was confirmed by a number of studies (Boniface et al., 2018 , Boniface\& Seneschal., 2019 , Riding\& Harris., 2019) showing that stable and active vitiligo perilesional skin is enriched with a population of CD8 TRM expressing both CD69 and CD103. CD8 TRM expressing CD103 are localized mainly in the epidermis. IL-15 is the only identified cytokine required for maintenance of CD8 TRM cells (Baumann et al., 2018 and Richmond et al., 2018).

Interleukin 15(IL-15) is one of Interleukin 2(IL-2) family members. It plays an important function in the pathogenesis of multiple cutaneous autoimmune diseases as psoriasis (Rückert et al.,2000) , alopecia areata (Ebrahim et al.,2019) and vitiligo (Atwa et al.,2020).

IL-15 receptor (IL-15R) is expressed on natural killer cells, dendritic cells, monocytes, fibroblasts, T cells and keratinocytes . IL-15R is composed of α (CD215), β (CD122), and γ (CD132) chains , The alpha chain occurs as both a soluble and a membrane-attached subunit (Vámosi et al., 2004 , Budagian et al., 2006 and Di Sabatino et al.,2011).

IL-15 stimulates neighbor cells by a trans-presentation mechanism through secretion of (IL-15. IL-15Rα complexes) from the surface of monocytes or dendritic cells into endosomes for its presentation in trans to neighboring cytotoxic cells or Natural killer cells ( Stonier \& Schluns .,2010).

IL-15 enhances maturation and survival of natural killer (NK) cells, neutrophils, and Dendritic cells (DCS) (Di Sabatino et al.,2011). Additionally, IL-15 promotes NK cell cytotoxicity and cytokine production such as interferon gamma( IFN-γ )and tumour necrosis factor alfa (TNF-α) (Fehniger \& Caligiuri .,2001). As for DCs, they regulate the development and survival of memory cytotoxic cells by IL-15 trans-presentation ( Budagian et al., 2006 and Stonier \& Schluns.,2010). Furthermore, IL-15 promotes T-cell receptor-dependent proliferation of Th17 (Di Sabatino et al.,2011).

TRM primarily express the CD122 (IL-15R β) subunit, a shared component of the receptors for IL-2 and IL-15, whereas keratinocytes express more CD215(IL-15Rα) in lesional compared to non lesional skin which is consistent with an ability to present IL-15 to T cells in trans (Richmond et al., 2018).

CD122(IL-15R β) expression is significantly higher on melanocyte-specific T cells in both mouse and human vitiligo compared to endogenous memory T cells, suggesting that autoreactive T cells are more dependent on IL-15 than non-autoreactive T cells. In addition, anti-CD122 blocking antibody inhibit IL-15 mediated T cell survival but not IL-2-mediated proliferation in vitro. This is consistent with the role of IL-15 in mediating T cell survival, but not proliferation (Riding et al., 2018).

These findings are consistent with an important role of IL-15 in maintenance of autoreactive TRM cells in vitiligo and suggest that this could be an effective targeted treatment strategy for vitiligo patients ( Frisoli et al., 2020).

Phototherapy has been considered as a cornerstone in management of vitiligo patients (Esmat et al., 2017). Narrow band ultraviolet B (NB-UVB) has been found to be an effective and well-tolerated treatment option in vitiligo compared to other available photo(chemo)therapy options (Sokolova et al., 2015).

Regarding effect of Ultraviolet B treatment on IL-15 in normal skin, it was found to increase IL-15 expression in epidermal and dermal sheets as well as in cultured keratinocytes and dermal fibro-blasts (Mohamadzadeh et al.,1995). However, this was negated by Blauvet et al. in 1996 who proved that IL-15 expression is down regulated by UVB in cultured keratinocytes in a dose and time dependent manner (Blauvet et al., 1996).

Being tested
Narrow band ultraviolet B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Narrow band ultraviolet BRadiation

    48 sessions of narrow band ultraviolet

Study groups in NCT05316987
Study groupRoleWhat they receive
Active vitiligo patientsOtherNBUVB
Receives: Radiation: Narrow band ultraviolet B

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 month

Secondary outcomes (2)
  1. Effect of activity of vitiligo on tissue level of Il-15 and IL-15Rα

    Correlation between tissue level of Il-15 and IL-15Rα before and after NB-UVB with activity score (vitiligo digns of activity score from 0 to 15)

    Measured: 4 months

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

    Correlation between tissue level of Il-15 and IL-15Rα before and after NB-UVB with extent score (Vitiligo extent plus score )

    Measured: 4 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2022
  2. Study start30 Apr 2022
  3. Primary completion30 Jul 2022
  4. Study completion30 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05316987
Sponsor's protocol ID
MS_ 270_2021
Status last verified
Aug 2022
First submitted
18 Feb 2022
Last updated
10 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: I will share the deidentified data sheet of the results of the trial

Questions about this trial

What is this clinical trial studying?

A study testing Narrow band ultraviolet B in people with Active Non Segmental Vitiligo, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of NB-UVB on tissue level of IL 15 and IL15Rα in active vitiligo (time frame: 4 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in