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Efficacy and Safety Phase II Study of VC005 Tablets in Subjects With Non-segmental Vitiligo

Not Applicable
Not yet recruiting
Conditions
Non-segmental Vitiligo
Interventions
Drug: VC005 tablets
Drug: VC005 Tablets Placebo
Registration Number
NCT07172347
Lead Sponsor
Jiangsu vcare pharmaceutical technology co., LTD
Brief Summary

This clinical trial is a multicenter, randomized, double-blind, controlled phase II clinical study

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
120
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
VC005 Tablets Low Dose groupsVC005 tablets-
VC005 Tablets Placebo groupsVC005 Tablets Placebo-
VC005 Tablets High Dose groupsVC005 tablets-
Primary Outcome Measures
NameTimeMethod
Percentage change in facial vitiligo area score index (F-VASI) relative to baseline at week 24Week 24
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The Peking University People's Hospital

🇨🇳

Beijing, Beijng, China

The Peking University People's Hospital
🇨🇳Beijing, Beijng, China
Jianzhong Zhang
Principal Investigator

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