Actively Recruiting
Topical Ruxolitinib for Face and Neck Vitiligo of Adult Chinese Patients Refractory to Topical Tacrolimus
Led by Hospital Authority, Hong Kong · Updated on 2024-12-05
20
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a prospective, open-label, single-center, split face randomized controlled study comparing 1.5% topical Ruxolitinib cream twice daily (BD) to aqueous cream in treating non-segmental vitiligo (NSV) of the face and neck in patient previous failed to respond to topical tacrolimus 0.1%. Aqueous cream twice daily application will be used as control group treatment. Patients with stable NSV at least 0.5% of their total body surface area (BSA) on the face and neck, as determined by the fingertip method, are screened. Recruited subjects will be asked to review their impression of change of their lesion by the end of the study using a 7-point scale.
CONDITIONS
Official Title
Topical Ruxolitinib for Face and Neck Vitiligo of Adult Chinese Patients Refractory to Topical Tacrolimus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- Clinical diagnosis of stable non-segmental vitiligo
- Depigmentation covering at least 0.5% of the body surface area on the face and neck
- Previous treatment with topical tacrolimus 0.1% twice daily for at least 3 months without significant response
- Agreement to stop other topical and systemic vitiligo treatments during the study except approved over-the-counter products and camouflage makeup
- Commitment to use effective birth control to prevent pregnancy or fathering a child throughout the study
- Ability to understand and provide informed consent
You will not qualify if you...
- Refusal to give consent
- Presence of other types of vitiligo or other skin depigmentation conditions such as piebaldism or leprosy
- History of using depigmentation treatments other than hydroquinone
- Skin conditions or infections affecting study participation or vitiligo evaluation
- Serious medical conditions limiting participation or increasing risk, including serious infections, untreated chronic hepatitis, recent malignancy, uncontrolled cardiovascular disease, thrombosis, blood abnormalities, or substance misuse
- Use of certain treatments within specific periods before baseline: topical vitiligo treatments within 1 week, immunomodulators, photosensitizers, oral retinoids, methoxsalen, or live vaccines within 4 weeks, laser or phototherapy on face and neck within 8 weeks, biologics within 12 weeks
- Prior use of topical or oral JAK inhibitors
- Hemoglobin under 10 g/dL, significant liver dysfunction, HIV infection or positive HIV antibodies, or immunodeficiency
- Females who are pregnant, breastfeeding, or planning pregnancy during the study
- Unlikely or unable to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Queen Mary Hospital, Hospital Authority
Hong Kong, Hong Kong
Actively Recruiting
Research Team
R
Research Assistant
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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