Evaluation Safety ,Efficacy Baricitinib Plus Excimer Light Versus Excimer Light Alone in Non Segmental Vitiligo

July 7, 2023 updated by: Noura Mohamed Aboud Tawfik, Assiut University

Evaluation of Safety and Efficacy of Topical Baricitinib Plus Excimer Light Versus Excimer Light Alone in Treatment in Non-Segmental Vitiligo

The study aims to evaluate the safety and efficacy of the combination of topical baricitinib and 308-nm monochromatic excimer light versus 308-nm monochromatic excimer light alone in treatment of non-segmental vitiligo.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Vitiligo is an acquired pigmentary skin disorder characterized by the absence of pigmentary cells from the epidermis that results in white macules and patches on the body. (1) The pathogenesis of vitiligo is unknown, but an autoim¬mune hypothesis prevails. (2, 3) CD8+ inflammatory damage induced by cytotoxic T cells is one of the key immune responses leading to depigmentation and destruction of melanocytes in vitiligo. (4-6) The IFN-γ - chemokine (CXCL9/10-CXCR3) axis, with its associated positive feedback loop, has been identified as a potential pathway in the initiation and progression of the immune response in vitiligo via inhibiting melanogenesis, inducing apoptosis of melanocytes, and further recruiting CD8+ T cells to the skin. (7-9) Janus kinases (JAKs) are a family of cytoplasmic tyrosine kinases (TYKs). (10) They aid cytokine-mediated signal transduction through the JAK/STAT pathway. (11) The key members of this unique tyrosine kinase family include JAK1, JAK2, JAK3, and TYK2. (12) The IFN-γ signaling is dependent on the JAK/STAT pathway. IFN-γ activates the JAK/STAT1 pathway, especially through JAK1 and JAK2. (13) This leads to the phosphorylation of STAT1, with subsequent transcription of IFNγ-induced genes, namely CXCL9 and CXCL10. (14) Given the role of JAK1 and JAK2 in the JAK/STAT pathway, IFN-γ signals can be blocked by inhibiting JAK1 or JAK2. (15) The treatment of vitiligo is generally and challenging, moreover, the goal of treatment is not only to halt disease progression, but promote repigmentation. (16) There are a variety of therapeutic possibilities including topical, systemic and surgical methods encompass grafting and transplantation. (17) The 308 nm excimer laser represents the latest alternative NB-UVB therapy for treating vitiligo. It's a gas laser that can emit a wavelength of 308 nm UVB produced by xenon and chlorine gases. (18) The effectiveness and safety of 308 nm excimer laser phototherapy are superior to that of NB-UVB phototherapy, which may be explained by the ability of the excimer laser to emit coherent pulses, as well as differences in phototherapeutic parameters, such as impulse frequency and intensity, therapy stimulating a deeper reservoir of melanocytes in hair follicles. (19) JAK inhibitors can block the IFN-γ signaling via the JAK-STAT pathway and thus have become an emerging treatment for vitiligo. (20) Based on clinical trials, the US Food and Drug Administration (FDA) approved topical Ruxolitinib 1.5%, a JAK 1 and 2 inhibitor, in patients 12 years of age or older for the treatment of non-segmental vitiligo. (21) In the treatment of vitiligo, a few published case reports, case series, and open-label studies have shown superior re-pigmentation rates in patients treated with JAK inhibitors, especially with concomitant ultraviolet or sun exposure. (22) Given IFN-γ signaling is specially mediated by JAK1 and JAK2, baricitinib, a newer JAK1 and JAK2 inhibitor, has been supposed to be effective in treating vitiligo. (23) The effectiveness of oral baricitinib in treating vitiligo has been reported in small case studies. (23-25) Some clinical studies have confirmed that the application of JAK inhibitors can have side effects, such as infection, malignancy, and major adverse cardiovascular events (MACEs). (26) Clinical disease screening of patients before the use of JAK inhibitors and continuous monitoring during their use are essential. (27) Topical administration of the drug results in improved drug delivery, fast onset of action, and the targeted distribution of the active medication to skin lesions while minimizing the safety concerns related to oral administration. Therefore, some experts believe that topical application show better effects and lower adverse reactions. (28, 29) Given the reported effectiveness of oral barcitinib in vitiligo as well as the successful results of topical forms of other JAK inhibitors, we expect that baricitinib would have similar effect if used topically.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

cooperation, agreement to join the study , Above 12 years old ,active non segmental vitiligo patients.

Description

Inclusion Criteria:

Patients of age above 12y old. Patients with active non-segmental vitiligo, having minimum of 1% body surface area (BSA) affected, with significant facial involvement (≥0.5% of the BSA on the face).

Co-operative patients, agree to join the study and will give consent.

Exclusion Criteria:

Patients receiving phototherapy or any form of systemic therapy for vitiligo during the previous 2 months preceding the study.

Patients applying topical medications to the face during the last month before the study Pregnant or lactating females. Patients with history of allergy to JAK inhibitors, or history of photosensitivity or post inflammatory hyperpigmentation.

Patients with active skin infection at site of treatment.

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
Group A
Vitiligo lesions on the face will be treated with cream (Olumiant)2mg twice daily and excimer light308nm DEKA, Florence,Italy twice weekly for 12 weeks.
Drug: Baricitinib
JAK inhibit0rs
Other Names:
  • Excimer light308nm
Group B
Vitiligo lesions on the face will be treated with excimer light308nm (DEKA,F lorence,Italy) only twice weekly for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
F VASI score
Time Frame: 6 months
Face Vitiligo Aera Scoring Index (F-VASI) score will be calculated at baseline, every 4 weeks during the first 12 weeks (duration of treatment) and 3 months after stopping treatment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Yasmin mostafa Tawfik, Doctor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 10, 2023

Primary Completion (Estimated)

September 20, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 7, 2023

First Posted (Actual)

July 18, 2023

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Baricitinib versus Excimer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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