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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu vcare pharmaceutical technology co., LTD

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • VC005 tablets

    Drug

    VC005 groups repeat administration for 52 weeks

  • VC005 Tablets Placebo

    Drug

    VC005 Placebo groups repeat administration for 52 weeks

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: VC005 Tablets Low Dose groupsExperimental treatment 1 intervention
Group B: VC005 Tablets High Dose groupsExperimental treatment 1 intervention
Group C: VC005 Tablets Placebo groupsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage change in facial vitiligo area score index (F-VASI) relative to baseline at week 24

Time frame
Week 24

Secondary outcomes

Other outcomes

Sponsors and contacts

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