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An evaluation on the efficacy and safety of tacrolimus 0.03% ointment in the treatment of labial lesions of chronic discoid lupus erythematosus and oral lichen planu: a randomized, positive controlled, parallel clinical trial

An evaluation on the efficacy and safety of tacrolimus 0.03% ointment in the treatment of labial lesions of chronic discoid lupus erythematosus and oral lichen planu: a randomized, positive controlled, parallel clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001195
Enrollment
Unknown
Registered
2011-02-18
Start date
2011-03-01
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

chronic discoid lupus erythematosus and oral lichen planus.

Interventions

Group A:Triamcinolone Acetonide Acetate Ointment the first week three times aday
the seconed week two times a day
the third week one times a day
Group B:Tacrolimus 0.03% ointment, the first week three times aday

Sponsors

West China College of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-60 years old; 2. Subject decided independently to participate in the study and sign informed consent; 3. Histopathologically and clinically proved erosive OLP/CDLE and have labial lesions; 4. The lesion size exceeding 5 mm in diameter; 5. Disease-process exceeding 2 months; 6. Negative reaction to pregnancy test in women.

Exclusion criteria

Exclusion criteria: 1. History of allergies to dexamethasone or a known history of serious drug hypersensitivities; 2. Those with other severe oral mucous diseases; 3. Those taking immunopotentiating or immunosuppressive agents during the previous 3 months; those having topical treatment within a week; 4. Have dieases with SLE; 5. Those with severe systemic diseases or abnormal hepatic or renal function test; a history of hepatitis C; 6. Pregnancy or intention of pregnancy or lactation or use of contraceptives of steroid hormone recently; 7. History of psychiatric disorders.

Design outcomes

Primary

MeasureTime frame
lesion size, pain level;

Countries

China

Contacts

Public ContactHongmei Zhou
acomnet@126.com+86 28 85503480

Outcome results

None listed

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