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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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