Recruiting NCT07172347
Efficacy and Safety Phase II Study of VC005 Tablets in Subjects With Non-segmental Vitiligo
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VC005 tablets, VC005 Tablets Placebo.
- Who it may be relevant to
- Registry conditions: Non-segmental Vitiligo. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
This clinical trial is a multicenter, randomized, double-blind, controlled phase II clinical study
Interventions
- Drug VC005 tablets
VC005 groups repeat administration for 52 weeks - Drug VC005 Tablets Placebo
VC005 Placebo groups repeat administration for 52 weeks
Primary outcome measures
- Percentage change in facial vitiligo area score index (F-VASI) relative to baseline at week 24 [Time frame: Week 24]
Eligibility criteria
Inclusion criteria
- The subject understands and voluntarily signs the informed consent form (ICF) and is willing and able to comply with the study protocol.
- The subject is between 18 and 70 years of age (including borderline values) , regardless of gender.
Exclusion criteria
- 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.
- Those who are known or suspected to be allergic to the main ingredients and excipients of VC005 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 (whichever is longer) prior to randomization.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07172347 · VC005-204