VitiligoNCT07153666
A Real-world Study on the Influencing Factors of Efficacy of Ruxolitinib Cream in Vitiligo
An observational study of Vitiligo, run by Peking University Third Hospital at 1 site in China.
Trial summary
Vitiligo is a common chronic autoimmune skin disease that can occur on any part of the body and severely impacts patients' quality of life. Current treatment for vitiligo primarily include topical medications, phototherapy, systemic therapy and surgical interventions, but their efficacy is limited, often failing to… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Ruxolitinib 1.5% Cream BID
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2025to 31 Dec 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: non-segmental vitiligo older than 12 years
Who may be able to join
- Age12 years or older, any gender;
- Signed"Informed Consent Form";
- Clinically diagnosed with non-segmental vitiligo;
- Vitiligo area less than 10% of body surface area;
- Agreed to discontinue all other vitiligo-related treatments from the screening visit until the final follow-up visit;
- Female subjects must not plan for pregnancy or oocyte donation from screening until 4 weeks after the last dose and must voluntarily adopt highly effective physical contraception; male subjects must not plan for fertility or sperm donation during the same period and must voluntarily adopt highly effective physical contraception. Methods include:
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- Barrier methods: Condom or barrier cap (diaphragm or cervical cap);
- Intrauterine device (IUD) or intrauterine system (IUS);
- Surgical sterilization (bilateral oophorectomy with/without hysterectomy, total hysterectomy, bilateral tubal ligation, or vasectomy) performed ≥6 months prior to the first dose in the subject or their partner;
- Other investigator-confirmed highly effective physical contraception.
Who cannot join
- Allergy to ruxolitinib cream;
- Pregnant or lactating women;
- Any condition deemed inappropriate for study participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100191
Jinzhu Guo, M.D., 008615611963350, guojinzhu_826@163.com
About this study
Official title: A Real-world Study on the Influencing Factors of the Efficacy of Ruxolitinib Cream in the Treatment of Vitiligo
Vitiligo is a common chronic autoimmune skin disease that can occur on any part of the body and severely impacts patients' quality of life. Current treatment for vitiligo primarily include topical medications, phototherapy, systemic therapy and surgical interventions, but their efficacy is limited, often failing to achieve ideal therapeutic outcomes, and are associated with a high recurrence rate. This study is an investigator-initiated real-world research on the application of ruxolitinib cream for vitiligo treatment, with the primary objective of exploring the factors influencing the efficacy of ruxolitinib cream in treating vitiligo.
Read the detailed description
Vitiligo is a common chronic autoimmune skin disease characterized by skin depigmentation, resulting in white patches that can occur on any part of the body and significantly impact patients' quality of life. Currently, treatment options for vitiligo primarily include topical medications, phototherapy, systemic therapy and surgery; however, their efficacy is limited, making it difficult to achieve optimal therapeutic outcomes,with a high recurrence rate. Studies have demonstrated that the JAK-STAT signaling pathway plays a critical role in autoimmune diseases and is involved in the pathogenesis of vitiligo. The JAK inhibitor ruxolitinib cream can improve skin lesions in patients with vitiligo. This study is an investigator-initiated real-world study on the use of ruxolitinib cream for the treatment of vitiligo, with the primary objective of investigating the factors influencing the efficacy of ruxolitinib cream in vitiligo treatment. Primary outcome measure: At Week 24, the clinical characteristic differences between the groups achieving and not achieving T-VASI50 [50% improvement of total vitiligo area scoring index (T-VASI)]. Secondary outcome measures:
(1) At Week 12 and Week 24, the proportion of patients scoring 4(slightly noticeable) or 5(no longer noticeable) on the Vitiligo Noticeability Scale (VNS), as well as the distribution of patients within each category; (2) Change from baseline in vitiligo-specific quality-of-life score (vitiligo-specific quality-of-life, VitiQoL) at Week 12 and Week 24; (3) Proportion achieving T-VASI 50/75/90 at Week 12 and Week 24; (4) Proportion achieving F-VASI 50/75/90[facial vitiligo area scoring index(F-VASI)] at Week 12 and Week24.
- Conditions
- Vitiligo
- Being tested
- Ruxolitinib 1.5% Cream BID
- Keywords
- vitiligo, JAK, ruxolitinib, treatment, efficacy, influencing factors
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib 1.5% Cream BIDDrug
ruxolitinib twice per day
| Study group | Role | What they receive |
|---|---|---|
| ruxolitinib | ruxolitinib twice per day Receives: Drug: Ruxolitinib 1.5% Cream BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of achieving T-VASI50 (50% improvement of total vitiligo area scoring index T-VASI)
First, determine the body parts to be evaluated, including the face and neck, palms, upper limbs, trunk, lower limbs and feet, five regions in total. Using the patient's palm as 1% of body surface area to estimate the area of depigmented patches in each body part, measuring the area of depigmented patches within each region. The T-VASI score categorizes the degree of depigmentation into seven levels: 0%, 10%,25%,50%,75%,90%, or 100%. Based on the area of depigmented patches and the degree of depigmentation in each region, the score for each region is calculated according to the T-VASI scoring formula. The specific calculation formula is:T-VASI=∑(number of handprint units occupied by each body part)× the percentage of pigment loss in that region. The score ranges from 0 to 100. The T-VASI50 score represents the proportion of subjects who achieve a≥50% improvement in the Vitiligo Area Scoring Index compared to baseline.
Measured: Week 24
Secondary outcomes (4)
the proportion of patients scoring 4(slightly noticeable) or 5(no longer noticeable) on the Vitiligo Noticeability Scale (VNS)
Vitiligo Noticeability Scale (VNS), a patient-reported outcome measure designed to assess the perceived change in the visibility of facial vitiligo following treatment. Patients are asked to compare the current noticeability of their vitiligo to how it appeared before treatment began. The scale offers five response options, each corresponding to a numerical score:
More noticeable (score = 1) Equally noticeable (score = 2) Slightly less noticeable (score = 3) Much less noticeable (score = 4) No longer noticeable (score = 5)
Measured: Week 12 and Week 24
Change from baseline in VitiQoL(vitiligo-specific quality-of-life）
Vitiligo-Specific Quality of Life Scale, a comprehensive patient-reported instrument designed to assess the impact of vitiligo on an individual's daily life and well-being over the past month.The scale consists of 16 items. The first 15 items evaluate the frequency and extent of vitiligo's influence across various domains, including emotional state (e.g., feelings of annoyance, embarrassment, depression), social interactions (e.g., worries about others' opinions, difficulty making new friends), daily activities (e.g., clothing choices, grooming, leisure activities), and overall physical health. Patients rate the frequency of each experience on a 7-point Likert scale ranging from 0 ("Not at all") to 6 ("Always"). The final item asks patients to self-assess the overall severity of their skin condition on a similar scale from 0 ("No skin problem") to 6 ("The worst possible case").
Measured: Week 12 and Week 24
Proportion achieving T-VASI 75/90 (75/90% improvement of total vitiligo area scoring index T-VASI)
First, determine the body parts to be evaluated, including the face and neck, palms, upper limbs, trunk, lower limbs and feet, five regions in total. Using the patient's palm as 1% of body surface area to estimate the area of depigmented patches in each body part, measuring the area of depigmented patches within each region. The T-VASI score categorizes the degree of depigmentation into seven levels: 0%, 10%,25%,50%,75%,90%, or 100%. Based on the area of depigmented patches and the degree of depigmentation in each region, the score for each region is calculated according to the T-VASI scoring formula. The specific calculation formula is:T-VASI=∑(number of handprint units occupied by each body part)× the percentage of pigment loss in that region. The score ranges from 0 to 100. The T-VASI 75/90 score represents the proportion of subjects who achieve a≥75/90% improvement in the Vitiligo Area Scoring Index compared to baseline.
Measured: Week 12 and Week 24
Proportion achieving F-VASI 50/75/90(50/75/90% improvement in facial vitiligo area scoring index)
The facial Vitiligo Area Scoring Index (F-VASI) range 0 to 3, with higher scores representing a greater area of facial depigmentation across the forehead to original hairline, cheeks to jawline vertically and laterally from corner of mouth to tragus, nose, and eyelids. The F-VASI score categorizes the degree of depigmentation into seven levels: 0%, 10%,25%,50%,75%,90%, or 100%. Based on the area of depigmented patches and the degree of depigmentation in each region, the score for each region is calculated according to the F-VASI scoring formula. The specific calculation formula is: F-VASI=∑(number of handprint units occupied by each body part)× the percentage of pigment loss in that region. The score ranges from 0 to 100. The F-VASI50/75/90 score represents the proportion of subjects who achieve a≥50/75/90% improvement in the Vitiligo Area Scoring Index compared to baseline.
Measured: Week 12 and Week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start8 Dec 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo Jin-Zhu, Peking University Third Hospital
- Investigators
- Jinzhu Guo, MD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153666
- Sponsor's protocol ID
- M20250743
- Status last verified
- Dec 2025
- First submitted
- 22 Aug 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study on the Influencing Factors of the Efficacy of Ruxolitinib Cream in the Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT07153666
- Acronym / sponsor ID
- M20250743
- Conditions
- Vitiligo
- Keywords
- vitiligo, JAK, ruxolitinib, treatment, efficacy, influencing factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitiligo is a common chronic autoimmune skin disease that can occur on any part of the body and severely impacts patients' quality of life. Current treatment for vitiligo primarily include topical medications, phototherapy, systemic therapy and surgical interventions, but their efficacy is limited, often failing to achieve ideal therapeutic outcomes, and are associated with a high recurrence rate. This study is an investigator-initiated real-world research on the application of ruxolitinib cream for vitiligo treatment, with the primary objective of exploring the factors influencing the efficacy of ruxolitinib cream in treating vitiligo.
Detailed description
Vitiligo is a common chronic autoimmune skin disease characterized by skin depigmentation, resulting in white patches that can occur on any part of the body and significantly impact patients' quality of life. Currently, treatment options for vitiligo primarily include topical medications, phototherapy, systemic therapy and surgery; however, their efficacy is limited, making it difficult to achieve optimal therapeutic outcomes,with a high recurrence rate. Studies have demonstrated that the JAK-STAT signaling pathway plays a critical role in autoimmune diseases and is involved in the pathogenesis of vitiligo. The JAK inhibitor ruxolitinib cream can improve skin lesions in patients with vitiligo. This study is an investigator-initiated real-world study on the use of ruxolitinib cream for the treatment of vitiligo, with the primary objective of investigating the factors influencing the efficacy of ruxolitinib cream in vitiligo treatment. Primary outcome measure: At Week 24, the clinical characteristic differences between the groups achieving and not achieving T-VASI50 [50% improvement of total vitiligo area scoring index (T-VASI)]. Secondary outcome measures:
(1) At Week 12 and Week 24, the proportion of patients scoring 4(slightly noticeable) or 5(no longer noticeable) on the Vitiligo Noticeability Scale (VNS), as well as the distribution of patients within each category; (2) Change from baseline in vitiligo-specific quality-of-life score (vitiligo-specific quality-of-life, VitiQoL) at Week 12 and Week 24; (3) Proportion achieving T-VASI 50/75/90 at Week 12 and Week 24; (4) Proportion achieving F-VASI 50/75/90[facial vitiligo area scoring index(F-VASI)] at Week 12 and Week24.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ruxolitinib | – | Drug: Ruxolitinib 1.5% Cream BIDruxolitinib twice per day |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- non-segmental vitiligo older than 12 years
Key inclusion criteria (10 listed)
- Age12 years or older, any gender;
- Signed"Informed Consent Form";
- Clinically diagnosed with non-segmental vitiligo;
- Vitiligo area less than 10% of body surface area;
- Agreed to discontinue all other vitiligo-related treatments from the screening visit until the final follow-up visit;
Key exclusion criteria (3 listed)
- Allergy to ruxolitinib cream;
- Pregnant or lactating women;
- Any condition deemed inappropriate for study participation by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib 1.5% Cream BIDruxolitinib twice per day | Drug | ruxolitinib |
Primary outcome
the proportion of achieving T-VASI50 (50% improvement of total vitiligo area scoring index T-VASI)
Time frame: Week 24
First, determine the body parts to be evaluated, including the face and neck, palms, upper limbs, trunk, lower limbs and feet, five regions in total. Using the patient's palm as 1% of body surface area to estimate the area of depigmented patches in each body part, measuring the area of depigmented patches within each region. The T-VASI score categorizes the degree of depigmentation into seven levels: 0%, 10%,25%,50%,75%,90%, or 100%. Based on the area of depigmented patches and the degree of depigmentation in each region, the score for each region is calculated according to the T-VASI scoring formula. The specific calculation formula is:T-VASI=∑(number of handprint units occupied by each body part)× the percentage of pigment loss in that region. The score ranges from 0 to 100. The T-VASI50 score represents the proportion of subjects who achieve a≥50% improvement in the Vitiligo Area Scoring Index compared to baseline.
4 secondary outcomes
the proportion of patients scoring 4(slightly noticeable) or 5(no longer noticeable) on the Vitiligo Noticeability Scale (VNS)
Time frame: Week 12 and Week 24
Change from baseline in VitiQoL(vitiligo-specific quality-of-life）
Time frame: Week 12 and Week 24
Proportion achieving T-VASI 75/90 (75/90% improvement of total vitiligo area scoring index T-VASI)
Time frame: Week 12 and Week 24
Proportion achieving F-VASI 50/75/90(50/75/90% improvement in facial vitiligo area scoring index)
Time frame: Week 12 and Week24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinzhu Guo, MD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitiligo, run by Peking University Third Hospital at 1 site in China.
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 10 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 2 Jan 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinzhu Guo, MD (008615611963350, guojinzhu_826@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of achieving T-VASI50 (50% improvement of total vitiligo area scoring index T-VASI) (time frame: Week 24). 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 2 Jan 2026.