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Could a drug plus light therapy reverse vitiligo? new trial tests the combo

NCT ID NCT04822584

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested whether adding the oral drug baricitinib to phototherapy (light treatment) helps restore skin color in adults with progressive vitiligo. 49 participants received either baricitinib plus phototherapy or a placebo plus phototherapy for 36 weeks. The main goal was to measure changes in the amount of skin affected by vitiligo using the VASI score.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Baricitinib (an oral drug that calms the immune system) plus phototherapy (light treatment)
What this could lead to
If it works, this could point toward a new treatment option that helps restore skin color in people with progressive vitiligo.
What could go wrong
This is a small, early-phase study (49 people) with no comparison to a standard treatment group. Results may not apply to everyone, and baricitinib can have side effects like infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

49 people

The number who actually took part.

Started

Jul 2021

Finished

Apr 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject: male or female aged ≥ 18 years and ≤ 75 years * Diagnosis of non-segmental (symmetrical) vitiligo with a body surface area involved \>5% excluding hands and feet * Active non-segmental vitiligo is defined by: * Non-segmental vitiligo with new patches or extension of old lesions during the last 6 months AND * Presence of hypochromic aspect under Wood's lamp examination and/or perifollicular hypopigmentation under Wood's lamp examination. * Able to read, understand, and give documented (electronic or paper signature) informed consent * Registered in the French Social Security * Agree to discontinue the use of the following excluded medications/treatments for at least 4 weeks prior to randomization (Visit 2) and throughout the study: systemic steroids, phototherapy, methotrexate, cyclosporine, mycophenolate mofetil, and azathioprine. * Agree to discontinue the use of the following excluded medications for at least 2 weeks prior to randomization (Visit 2) and throughout the study: * TCS or topical immune modulators (e.g., tacrolimus or pimecrolimus) * Topical phosphodiesterase type 4 (PDE-4) inhibitor (crisaborole) * Topical JAK inhibitor (e.g., tofacitinib or ruxolitinib) and/or any other investigational topical treatments. * Patient characteristics * Are male or nonpregnant, nonbreastfeeding female patients, except: 1. Male patients must agree to use 2 forms of birth control (1 must be highly effective, see below) while engaging in sexual intercourse with female partners of childbearing potential while enrolled in the study and for at least 4 weeks following the last dose of investigational product. 2. Female patients of childbearing potential must agree to use 2 forms of birth control, when engaging in sexual intercourse with a male partner while enrolled in the study and for at least 4 weeks following the last dose of investigational product. The following birth control methods are considered acceptable (the patient should choose 2 to be used with their male partner, and 1 must be highly effective): * Highly effective birth control methods: oral, injectable, or implanted hormonal contraceptives (combined estrogen/progesterone or progesterone only, associated with inhibition of ovulation); intrauterine device or intrauterine system (e.g., progestin-releasing coil); or vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate). * Effective birth control methods: condom with a spermicidal foam, gel, film, cream, or suppository; occlusive cap (diaphragm or cervical/vault caps) with a spermicidal foam, gel, film, cream, or suppository; or oral hormonal contraceptives. 3. Females of nonchildbearing potential are not required to use birth control and they are defined as: * Women ≥60 years of age or women who are congenitally sterile, or * Women ≥40 and \<60 years of age who have had a cessation of menses for ≥12 months and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (≥40 mIU/mL or ≥40 IU/L), or women who are surgically sterile (i.e., have had a hysterectomy or bilateral oophorectomy or tubal ligation). * Signed informed consent form (ICF) Exclusion Criteria: * Segmental or mixed vitiligo * Patients that are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus) that would interfere with evaluations of the effect of study medication on vitiligo * Patients who are currently experiencing a skin infection that requires treatment, or who are currently being treated with topical or systemic antibiotics. Note: Patients may not be rescreened until at least 4 weeks after the date of their previous screen failure and at least 2 weeks after resolution of the infection. * Patients that have any serious concomitant illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring. (e.g., unstable chronic asthma). * Patients that have been treated with the following therapies: 1. Monoclonal antibody (e.g., ustekinumab, omalizumab, dupilumab) for less than 5 half-lives prior to randomization. 2. Received prior treatment with any oral JAK inhibitor (e.g., tofacitinib,ruxolitinib) 3. Received any systemic corticosteroid administered within 4 weeks prior to planned randomization or are anticipated to require systemic corticosteroids during the study. 4. Have had an intra-articular corticosteroid injection within 4 weeks prior to planned randomization. 5. Have received more than 250 sessions of UV lights therapies. * Patients that are largely or wholly incapacitated permitting little or no self-care, such as being bedridden. * Patients that have uncontrolled arterial hypertension characterized by a repeated systolic blood pressure \>160 mm Hg or diastolic blood pressure \>100 mm Hg in a seated position. * Patients that have had any major surgery within 8 weeks prior to screening or that will require major surgery during the study that, in the opinion of the investigator, would pose an unacceptable risk to the patient. * Patients that are immunocompromised and, in the opinion of the investigator, at an unacceptable risk for participating in the study. * Patients that have experienced any of the following event within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure. * Patients that have a history of recurrent (≥ 2) VTE or are considered at high risk of VTE as deemed by the investigator. * Patients that have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data. * Patients that have a history of lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for less than 5 years : 1. Patients with cervical carcinoma in situ that has been resected with no evidence of recurrence or metastatic disease for at least 3 years may participate in the study. 2. Patients with basal cell or squamous epithelial skin cancers that have been completely resected with no evidence of recurrence for at least 3 years may participate in the study. * Patients that have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection, including but not limited to the following: Note: A recent viral upper respiratory tract infection or uncomplicatedurinary tract infection should not be considered clinically serious. 1. symptomatic herpes zoster infection within 12 weeks prior to screening. 2. history of disseminated/complicated herpes zoster (e.g., multidermatomal involvement, ophthalmic zoster, CNS involvement, or post-herpetic neuralgia). 3. symptomatic herpes simplex at the time of randomization. 4. active or chronic viral infection from hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). 5. household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB. 6. evidence of active TB or have previously had evidence of active TB and did not receive appropriate and documented treatment. 7. clinically serious infection or received intravenous antibiotics for an infection, within the past 4 weeks of randomization. 8. any other active or recent infection within 4 weeks of randomization that, in the opinion of the investigator, would pose an unacceptable risk to the patient if participating in the study. * Patients that have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination). Note: Patients eligible for herpes zoster vaccine, who have not received it prior to screening will be encouraged (per local guidelines) to do so prior to randomization; vaccination must occur \>4 weeks prior to randomization and start of investigational product. Patients will be excluded if they were exposed to herpes zoster vaccination within 4 weeks of planned randomization. Investigators should review the vaccination status of their patients and follow the local guidelines for vaccination of those ≥18 years of age with nonlive vaccines intended to prevent infectious disease prior to entering patients into the study * Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within the 2 years prior to screening. * Presence of significant uncontrolled neuropsychiatric disorder, are clinically judged by the investigator to be at risk for suicide. * Have donated more than a single unit of blood within 4 weeks prior to screening or intend to donate blood during the course of the study. Other non inclusion criteria: * Are unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow study restrictions/procedures. * Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. * Have participated within the last 30 days in a clinical study involving an investigational product. If the previous investigational product has a long half-life (2 weeks or longer), at least 3 months or 5 half-lives (whichever is longer) should be allowed between the end of the previous treatment and the inclusion. * Have previously been randomized in this study or any other study investigating baricitinib. * Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. Diagnostic Assessments * Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator, are clinically significant and indicate an unacceptable risk for the patient's participation in the study. * Have evidence of active TB or latent TB: 1. have evidence of active TB, defined in this study as the following: * Documented by a positive PPD test (≥5 mm induration between approximately 48 and 72 hours after application, regardless of vaccination history), medical history, clinical features, and abnormal chest x-ray at screening. * The QuantiFERON®-TB Gold test or T-SPOT®.TB test (as available and if compliant with local TB guidelines) may be used instead of the PPD test. Patients are excluded from the study if the test is not negative and there is clinical evidence of active TB. Exception: Patients with a history of active TB who have documented evidence of appropriate treatment, have no history of re-exposure since their treatment was completed, and have a screening chest x-ray with no evidence of active TB may be enrolled if other entry criteria are met. Such patients would not be required to undergo the protocol-specific TB testing for PPD, QuantiFERON®-TB Gold test, or T-SPOT® TB test but must have a chest x-ray at screening.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Centre Hospitalier Universitaire de Nice - Service de Dermatologie

    Nice, 06000, France

  • Service de Dermatologie - Hôpital Saint-André

    Bordeaux, Bordeaux, 33075, France

  • Service de dermatologie - Hôpital Henri Mondor - EA EpiDermE (Epidémiologie en Dermatologie et Evaluation des Thérapeutiques)

    Créteil, 94010, France

  • Service de dermatologie Centre de Référence des Maladies Rares de la Peau et des muqueuses d'origine génétique - Hôpital Larrey

    Toulouse, 31059 cedex 9, France

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