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A Randomized Controlled Trial for investigation of the effect and the safety of tacrolimus 0.03% Ointment in the treatment of chronic cheilitis

A Randomized Controlled Trial for investigation of the effect and the safety of tacrolimus 0.03% Ointment in the treatment of chronic cheilitis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17013527
Enrollment
Unknown
Registered
2017-11-24
Start date
2018-01-01
Completion date
Unknown
Last updated
2017-11-27

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

Conditions

chronic cheilitis

Interventions

experimental group:tacrolimus 0.03% ointment is local uesd on lips
control group:acetonide 0.1% cream is local used on lips

Sponsors

West China Hospital of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. history and the clinical manifestation of dry desquamation or eczema debaucjed of lips'; 2. aged 18~60 years; 3. the disease course is more than 2 months; 4. no abnormal with vital signs, routine physical examination and neurofunctional tests; 5. Volunteer to participate in and sign informed consent, good compliance with the medical advice, and be able to return on time.

Exclusion criteria

Exclusion criteria: 1. there is other disease characteristiced as erosive or other lesions on lips; 2. some severe dieases of mucosa; 3. Neuropsychiatric disorders, such as anxiety and depression, are being diagnosed and under the drug treatment; 4. Serious systemic disease or the abnormol value is above normal 30%; 5. local or system treatment with immunosuppressant in 2 weeks; 6. allergic to tacrolimus, acetonide, or other serious drug allergy history; 7. difficult to cooperate with doctor for the mental disorder; 8. pregnancy, intention of pregnancy, lactation,or use of systemic corticosteroids for the treatment of any diseases nearly; 9. addiction to smoking and alcohol; 10. participation in any other clinical trials in the 3 months before enrollment in this study.

Design outcomes

Primary

MeasureTime frame
dryness (physical sign);desquamation (physical sign);rhagades(physical sign);swell(physical sign);plasma concentration;

Secondary

MeasureTime frame
dryness (symptom);desquamation(symptom);pain (symptom);itch (symptom);burning sensation (symptom);

Countries

China

Contacts

Public ContactHongmei Zhou

West China Hospital of Stomatology, Sichuan University

acomnet@126.com+86 028 85503480

Outcome results

None listed

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