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Efficacy and Safety of Ruxolitinib Phosphate Cream Combined With Corticosteroids in Patients With Progressive Non-Segmental Vitiligo: A Multicenter Real-World Study

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

This study is a prospective, multicenter, real-world observational study to assess the clinical efficacy and safety of topical 1.5% Ruxolitinib phosphate cream used in combination with systemic corticosteroids in a real-world clinical setting. The study plans to observe patients aged 12 years and older with active, progressive non-segmental vitiligo involving the face. All treatments are prescribed based on standard routine clinical care and medical practice guidelines. Participants will apply Ruxolitinib cream twice daily to affected skin areas for up to 24 weeks alongside a standard corticosteroid regimen. The primary goal of the study is to evaluate how many patients achieve a 75% or greater improvement in their facial vitiligo patches after 12 weeks of combined treatment. Safety and side effects will also be closely monitored throughout the 24-week period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Age ≥ 12 years at the time of signing informed consent.

• Clinical diagnosis of non-segmental vitiligo with facial involvement, and total body surface area (BSA) depigmentation ≤ 10%.

• Diagnosed with progressive/active vitiligo meeting at least one of the following: Vitiligo Disease Activity (VIDA) score ≥ 3.

⁃ Clinical signs including trichrome vitiligo, confetti-like depigmentation, or Koebner phenomenon.

⁃ The extent of lesions under Wood's lamp is larger than that visible to the naked eye.

• Agrees to have no pregnancy plans and uses effective contraception during the study and up to 4 weeks after the last dose.

• Voluntarily signs the informed consent form and agrees to regular follow-up visits.

Locations
Other Locations
China
Changzhou First People's Hospital
NOT_YET_RECRUITING
Changzhou
Dongying People's Hospital
NOT_YET_RECRUITING
Dongying
Dongying People's Hospital
RECRUITING
Dongying
The Second People's Hospital of Huai'an
NOT_YET_RECRUITING
Huai'an
Central Hospital of Jiaozuo Coal Industry (Group) Co., Ltd.
NOT_YET_RECRUITING
Jiaozuo
The Second Hospital of Lanzhou University
RECRUITING
Lanzhou
The First People's Hospital of Lianyungang
NOT_YET_RECRUITING
Lianyungang
Nanjing Drum Tower Hospital
NOT_YET_RECRUITING
Nanjing
U-Family Clinic (Nanjing) Co., Ltd.
NOT_YET_RECRUITING
Nanjing
People's Hospital of Ningxia Hui Autonomous Region
RECRUITING
Ningxiang
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
RECRUITING
Shanghai
Changzhi Second People's Hospital
NOT_YET_RECRUITING
Shangxi
Shenzhen Hospital of Southern Medical University
RECRUITING
Shenzhen
Shenzhen Hospital, Southern Medical University
NOT_YET_RECRUITING
Shenzhen
Shiyan People's Hospital (Hubei University of Medicine Affiliated People's Hospital)
NOT_YET_RECRUITING
Shiyan
The First Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
The Fourth Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITING
Xuzhou
Contact Information
Primary
ShanShan Li
lishanshan@cms.net.cn
+86 18201346463
Time Frame
Start Date: 2026-07-02
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 300
Related Therapeutic Areas
Sponsors
Leads: ShanShan Li

This content was sourced from clinicaltrials.gov