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A Multicenter, Randomized, Double-blind, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of VC005 Tablets in Subjects With Non-segmental Vitiligo
Led by Jiangsu vcare pharmaceutical technology co., LTD · Updated on 2026-01-02
120
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
This clinical trial is a phase II, multicenter, randomized, double-blind, controlled study evaluating the efficacy and safety of VC005 tablets in people with non-segmental vitiligo. The trial is sponsored by Jiangsu vcare pharmaceutical technology co., LTD and aims to assess how well VC005 works for this skin condition. Participants will be randomly assigned to one of three groups: low-dose VC005 tablets, high-dose VC005 tablets, or a placebo group. All groups will receive their assigned treatment repeatedly for 52 weeks. The study includes a placebo control to compare the effects of VC005 tablets at different doses. During the study, participants' facial vitiligo area will be measured to track changes from baseline up to week 24. The main outcome is the percentage change in the facial vitiligo area score index (F-VASI). The trial will monitor participants for a total duration of up to 52 weeks, with ongoing assessments to evaluate safety and treatment effects.
CONDITIONS
Brief Title
Efficacy and Safety Phase II Study of VC005 Tablets in Subjects With Non-segmental Vitiligo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The subject understands and voluntarily signs the informed consent form and is willing and able to comply with the study protocol.
- The subject is between 18 and 70 years of age, regardless of gender.
You will not qualify if you...
- Pregnant or lactating women, or subjects with pregnancy or lactation plans during the study period.
- All hair in the vitiligo area on the face is white.
- Known or suspected allergy to VC005 main ingredients or similar drugs.
- Subjects who have previously received depigmentation treatment.
- Subjects who have received experimental drug administration or participated in device clinical trials within the first month or 5 half lives prior to randomization.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 52 weeks
Participants receive VC005 tablets or placebo with repeated administration for 52 weeks.
Trial Site Locations
Total: 1 location
1
The Peking University People's Hospital
Beijing, Beijng, China
Actively Recruiting
Research Team
X
xiaojuan lai
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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