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Evaluation of safety and efficacy of Protopic for vitiliginous patients

An open, self-control and multiple-center study to evaluate safety and efficacy of Protopic (0.1% tacrolimus) for vitiliginous patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-10000797
Enrollment
Unknown
Registered
2010-03-15
Start date
2010-04-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitiligo

Interventions

Group A:Administration of 0.1%Tacrolimus

Sponsors

China Dermatologist Association
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with vitiliginous lesions on face/ neck (Examination with Wood's light); 2. Stable vitiligo; 3. With informed consent form signed.

Exclusion criteria

Exclusion criteria: 1. Acral and scattered vitiligo, automatic re-color tendency; 2. Koebner history; 3. Light treatment in 4 weeks; 4. Local therapy by using hormone, immunoregulant (eg. Pimecrolimus), and VitD derivant (eg. Daivonex); 5. Taken medicine such as methopterin, etretinate and ciclosporine in 2 weeks; 6. Skin transplantation failure; 7. Taking photosensitive drug; 8. Other skin diseases which might affect efficacy observation caused by infection, tumor and auto-immune disease; 9. Known allergy to Tacrolimus or ingredients in Tacrolimus ointment; 10. Pregnancy or breasting.

Design outcomes

Primary

MeasureTime frame
Level of pigment restoration;Area of pigment restoration;

Countries

China

Contacts

Public ContactXuejun Zhu
zhuxj@public.bta.net.cn+86 010 66551122

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026