{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T15:31:00Z","timestamp":1782228660935,"version":"3.54.5"},"reference-count":40,"publisher":"MDPI AG","issue":"22","license":[{"start":{"date-parts":[[2021,11,22]],"date-time":"2021-11-22T00:00:00Z","timestamp":1637539200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Topical cyclosporine (CSA) has been reported as an alternative treatment in steroid-refractory oral lichen planus (OLP), but evidence is limited and conflicting. An N-of-1 trial setting could be appropriate to evaluate interindividual differences in treatment response. We studied a series of 21 open-label, biphasic single-patient observations. Patients (15 women, 6 men) with OLP recalcitrant to topical steroids received four weeks of CSA mouth rinse (200 mg\/twice daily) followed by four weeks of drug withdrawal. Pain (visual analogue scale (VAS) score), disease extent (physicians\u2019 global assessment (PGA) score) and quality of life (Dermatology Life Quality Index (DLQI) score,) were assessed at baseline (T0), after four weeks of treatment (T1) and after another four weeks without treatment (T2). Median age was 58 years (interquartile range\/IQR = 52\u201367) and median disease duration was 18 months (IQR = 12\u201344). Median baseline VAS score decreased significantly at T1 (p = 0.0003) and increased at T2 (p = 0.032) (T0 = 5 (IQR = 3\u20136.5); T1 = 2 (IQR = 0.5\u20133.4); T2 = 3 (IQR = 2\u20134.8)). Similarly, median baseline PGA score decreased significantly at T1 (p = 0.001) and increased at T2 (p = 0.007) (T0 = 2 (IQR = 1.3\u20132.5); T1 = 1 (IQR = 1\u20132); T2 = 2 (IQR = 1\u20132)). Median baseline DLQI score also decreased significantly at T1 (p =.027) but did not change at T2 (p = 0.5) (T0 = 2.5 (IQR = 1\u20135.8); T1 = 1 (IQR = 0\u20133); T2 = 1 (IQR = 1\u20134)). CSA responders (n = 16) had significantly higher median baseline VAS scores (5.2 (IQR = 5\u20136.5)) than nonresponders (n =5) (2 (IQR = 2\u20133.5) (p = 0.02). In our study, pain, disease extent and quality of life of patients with OLP improved significantly during therapy with low-dose CSA mouth rinse and exacerbated after drug withdrawal. Remarkably, patients with high initial VAS scores seemed to profit most.<\/jats:p>","DOI":"10.3390\/jcm10225454","type":"journal-article","created":{"date-parts":[[2021,11,30]],"date-time":"2021-11-30T23:22:28Z","timestamp":1638314548000},"page":"5454","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Topical Cyclosporine in Oral Lichen Planus\u2014A Series of 21 Open-Label, Biphasic, Single-Patient Observations"],"prefix":"10.3390","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2988-2380","authenticated-orcid":false,"given":"Babak","family":"Monshi","sequence":"first","affiliation":[{"name":"Department of Dermatology and Venereology, Klinik Landstra\u00dfe, Juchgasse 25, 1030 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Ellersdorfer","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Venereology, Klinik Landstra\u00dfe, Juchgasse 25, 1030 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Edelmayer","sequence":"additional","affiliation":[{"name":"Clinical Division of Oral Surgery, University Clinic of Dentistry, Medical University of Vienna, Sensengasse 2a, 1090 Vienna, Austria"},{"name":"Center of Clinical Research, University Clinic of Dentistry, Medical University of Vienna, Sensengasse 2a, 1090 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriella","family":"Dvorak","sequence":"additional","affiliation":[{"name":"Clinical Division of Conservative Dentistry and Periodontology, University Clinic of Dentistry, Medical University of Vienna, Sensengasse 2a, 1090 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clemens","family":"Ganger","sequence":"additional","affiliation":[{"name":"Clinical Division of Oral Surgery, University Clinic of Dentistry, Medical University of Vienna, Sensengasse 2a, 1090 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Ulm","sequence":"additional","affiliation":[{"name":"Clinical Division of Oral Surgery, University Clinic of Dentistry, Medical University of Vienna, Sensengasse 2a, 1090 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Klemens","family":"Rappersberger","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Venereology, Klinik Landstra\u00dfe, Juchgasse 25, 1030 Vienna, Austria"},{"name":"School of Medicine, Sigmund Freud Private University Vienna, Freudplatz 1, 1020 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Igor","family":"Vujic","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Venereology, Klinik Landstra\u00dfe, Juchgasse 25, 1030 Vienna, Austria"},{"name":"School of Medicine, Sigmund Freud Private University Vienna, Freudplatz 1, 1020 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2021,11,22]]},"reference":[{"key":"ref_1","first-page":"S25.e1","article-title":"Oral lichen planus and oral lichenoid le-sions: Diagnostic and therapeutic considerations","volume":"103","author":"Schifter","year":"2007","journal-title":"Oral Surg. Oral Med. Oral Pathol. Oral Radiol. Endodontol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"338","DOI":"10.1111\/j.1601-0825.2005.01142.x","article-title":"Number V Oral lichen planus: Clinical features and management","volume":"11","author":"Eisen","year":"2005","journal-title":"Oral Dis."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"271","DOI":"10.1067\/mjd.2002.120922","article-title":"Fluticasone propionate spray and betamethasone sodium phosphate mouthrinse: A randomized crossover study for the treatment of symptomatic oral lichen planus","volume":"47","author":"Hegarty","year":"2002","journal-title":"J. Am. Acad. Dermatol."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"179","DOI":"10.1590\/S0103-64402008000300001","article-title":"Role of apoptosis in erosive and reticular oral lichen planus exhibiting variable epithelial thickness","volume":"19","author":"Brant","year":"2008","journal-title":"Braz. Dent. J."},{"key":"ref_5","doi-asserted-by":"crossref","unstructured":"Cheng, S., Kirtschig, G., Cooper, S., Thornhill, M., Leonardi-Bee, J., and Murphy, R. (2012). Interventions for erosive lichen planus affecting mucosal sites. Cochrane Database Syst. Rev.","DOI":"10.1002\/14651858.CD008092.pub2"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1016\/S1368-8375(03)00139-8","article-title":"Risk of oral squamous cell carcinoma in 402 patients with oral lichen planus: A follow-up study in an Italian population","volume":"40","author":"Gandolfo","year":"2003","journal-title":"Oral Oncol."},{"key":"ref_7","doi-asserted-by":"crossref","unstructured":"Lodi, G., Manfredi, M., Mercadante, V., Murphy, R., and Carrozzo, M. (2020). Interventions for treating oral lichen planus: Corticosteroid therapies. Cochrane Database Syst. Rev.","DOI":"10.1002\/14651858.CD001168.pub3"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"290","DOI":"10.1056\/NEJM199008023230502","article-title":"Effect of Topical Cyclosporine Rinse on Oral Lichen Planus","volume":"323","author":"Eisen","year":"1990","journal-title":"N. Engl. J. Med."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"532","DOI":"10.1016\/S1079-2104(96)80198-3","article-title":"Topical cyclosporine in a bioadhesive for treatment of oral lichenoid mucosal reactions: An open label clinical trial","volume":"82","author":"Epstein","year":"1996","journal-title":"Oral Surg. Oral Med. Oral Pathol. Oral Radiol. Endodontol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"684","DOI":"10.1111\/ced.12858","article-title":"Oral tacrolimus: A treatment option for recalcitrant erosive lichen planus","volume":"41","author":"Yeo","year":"2016","journal-title":"Clin. Exp. Dermatol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"936","DOI":"10.1111\/j.1365-2133.2008.08726.x","article-title":"Pimecrolimus cream 1% in erosive oral lichen planus- a prospective randomized double-blind vehicle-controlled study","volume":"159","author":"Volz","year":"2008","journal-title":"Br. J. Dermatol."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"161","DOI":"10.1016\/S1079-2104(05)80195-7","article-title":"Effectiveness of a low dose of cyclosporine in the management of patients with oral erosive lichen planus","volume":"80","author":"Harpenau","year":"1995","journal-title":"Oral Surg. Oral Med. Oral Pathol. Oral Radiol. Endodontol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"555","DOI":"10.1046\/j.1365-2230.2002.01148.x","article-title":"Calcineurin inhibitors and sirolimus: Mechanisms of action and applications in dermatology","volume":"27","author":"Reynolds","year":"2002","journal-title":"Clin. Exp. Dermatol."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"1009","DOI":"10.1111\/j.1468-3083.2007.02539.x","article-title":"Pimecrolimus in an adhesive ointment is safe and effective in long-term treatment for oral lichen planus","volume":"22","author":"Dissemond","year":"2008","journal-title":"J. Eur. Acad. Dermatol. Venereol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"1061","DOI":"10.1111\/j.1468-3083.2010.03923.x","article-title":"Pimecrolimus 1% cream for oral erosive lichen planus: A 6-week randomized, double-blind, vehicle-controlled study with a 6-week open-label extension to assess efficacy and safety","volume":"25","author":"McCaughey","year":"2010","journal-title":"J. Eur. Acad. Dermatol. Venereol."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"475","DOI":"10.1111\/jdv.12128","article-title":"Pimecrolimus vs. tacrolimus for the topical treatment of unresponsive oral erosive lichen planus: A 8 week randomized double-blind controlled study","volume":"28","author":"Arduino","year":"2013","journal-title":"J. Eur. Acad. Dermatol. Venereol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"1166","DOI":"10.1111\/bjd.17898","article-title":"Topical calcineurin inhibitors in the treatment of oral lichen planus: A systematic review and meta-analysis","volume":"181","author":"Sun","year":"2019","journal-title":"Br. J. Dermatol."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"1107","DOI":"10.1111\/jdv.12758","article-title":"Efficacy of topical tacrolimus for oral lichen planus: Real-life experience in a retrospective cohort of patients with a review of the literature","volume":"29","author":"Naldi","year":"2015","journal-title":"Acad. Dermatol. Venereol."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"554","DOI":"10.1111\/j.1468-3083.2006.01953.x","article-title":"The use of topical calcineurin inhibitors in the management of oral lichen planus","volume":"21","author":"Chaudhry","year":"2006","journal-title":"J. Eur. Acad. Dermatol. Venereol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"938","DOI":"10.1111\/j.1365-2133.2012.10821.x","article-title":"Interventions for treating oral lichen planus: A systematic review","volume":"166","author":"Lodi","year":"2012","journal-title":"Br. J. Dermatol."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"139","DOI":"10.1111\/j.1365-2133.2005.06920.x","article-title":"Ciclosporin vs. clobetasol in the topical management of atrophic and erosive oral lichen planus: A double-blind, randomized controlled trial","volume":"154","author":"Conrotto","year":"2005","journal-title":"Br. J. Dermatol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1067\/mjd.2002.120452","article-title":"The clinical features, malignant potential, and systemic associations of oral lichen planus: A study of 723 patients","volume":"46","author":"Eisen","year":"2002","journal-title":"J. Am. Acad. Dermatol."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"1007","DOI":"10.1017\/S0033291700009934","article-title":"Clinical applications of visual analogue scales: A critical review","volume":"18","author":"McCormack","year":"1988","journal-title":"Psychol. Med."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"210","DOI":"10.1111\/j.1365-2230.1994.tb01167.x","article-title":"Dermatology Life Quality Index (DLQI)-a simple practical measure for routine clinical use","volume":"19","author":"Finlay","year":"1994","journal-title":"Clin. Exp. Dermatol."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"707","DOI":"10.1016\/j.ajem.2018.01.008","article-title":"A systematic review of the pain scales in adults: Which to use?","volume":"36","author":"Karcioglu","year":"2018","journal-title":"Am. J. Emerg. Med."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"30","DOI":"10.1016\/0030-4220(85)90210-5","article-title":"A prospective follow-up study of 570 patients with oral lichen planus: Persistence, remission, and malignant association","volume":"60","author":"Silverman","year":"1985","journal-title":"Oral Surg. Oral Med. Oral Pathol."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"194","DOI":"10.1159\/000248548","article-title":"Effect of the Local Application of Ciclosporine A on Chronic Erosive Lichen planus of the Oral Cavity","volume":"177","author":"Boisnic","year":"1988","journal-title":"Dermatology"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"60","DOI":"10.1016\/S0901-5027(96)80014-2","article-title":"Cyclosporin A mouthwash in the treatment of oral lichen planus","volume":"25","author":"Jungell","year":"1996","journal-title":"Int. J. Oral Maxillofac. Surg."},{"key":"ref_29","doi-asserted-by":"crossref","unstructured":"Ho, V.C., and Conklin, R.J. (1991). Effect of Topical Cyclosporine Rinse on Oral Lichen Planus. N. Engl. J. Med., 325.","DOI":"10.1056\/NEJM199108083250619"},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"262","DOI":"10.1159\/000247464","article-title":"Lack of Effect after Local Treatment with a New Ciclosporin Formulation in Recalcitrant Erosive Oral Lichen planus","volume":"185","author":"Itin","year":"1992","journal-title":"Dermatology"},{"key":"ref_31","first-page":"33","article-title":"Cyclosporine A, an alternative to the oral lichen planus erosive treatment","volume":"38","author":"Llabres","year":"1995","journal-title":"Bull. Group. Int. Rech. Sci. Stomatol. Odontol."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"47","DOI":"10.1016\/j.tripleo.2005.09.006","article-title":"A randomized controlled trial to compare steroid with cyclosporine for the topical treatment of oral lichen planus","volume":"102","author":"Yoke","year":"2006","journal-title":"Oral Surg. Oral Med. Oral Pathol. Oral Radiol. Endodontol."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"142","DOI":"10.1111\/j.1600-0714.2007.00510.x","article-title":"A randomized-controlled trial to compare topical cyclosporin with triamcinolone acetonide for the treatment of oral lichen planus","volume":"36","author":"Thongprasom","year":"2007","journal-title":"J. Oral Pathol. Med."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"790","DOI":"10.1111\/j.1365-2133.1995.tb00728.x","article-title":"Topical cyclosporin in oral lichen planus: A controlled, randomized, prospective trial","volume":"132","author":"Sieg","year":"1995","journal-title":"Br. J. Dermatol."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"S21","DOI":"10.1016\/j.jclinepi.2013.04.006","article-title":"Single-patient (n-of-1) trials: A pragmatic clinical decision methodology for patient-centered comparative effectiveness research","volume":"66","author":"Duan","year":"2013","journal-title":"J. Clin. Epidemiol."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1016\/j.jclinepi.2015.05.018","article-title":"CONSORT extension for reporting N-of-1 trials (CENT) 2015: Explanation and elaboration","volume":"76","author":"Shamseer","year":"2016","journal-title":"J. Clin. Epidemiol."},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"765","DOI":"10.1111\/j.1365-2133.2007.08106.x","article-title":"A scoring system for mucosal disease severity with special reference to oral lichen planus","volume":"157","author":"Escudier","year":"2007","journal-title":"Br. J. Dermatol."},{"key":"ref_38","first-page":"3","article-title":"Development and evaluation of the Oral Health Impact Profile","volume":"11","author":"Slade","year":"1994","journal-title":"Community Dent. Health"},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"604","DOI":"10.1111\/j.1600-0714.2011.01021.x","article-title":"Validity and reliability of a newly developed quality of life questionnaire for patients with chronic oral mucosal diseases","volume":"40","author":"McCreary","year":"2011","journal-title":"J. Oral Pathol. Med."},{"key":"ref_40","doi-asserted-by":"crossref","first-page":"75","DOI":"10.1016\/j.oooo.2012.02.013","article-title":"Oral lichen planus: REU scoring system correlates with pain","volume":"114","author":"Park","year":"2012","journal-title":"Oral Surg. Oral Med. Oral Pathol. Oral Radiol."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/10\/22\/5454\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T07:34:04Z","timestamp":1760168044000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/10\/22\/5454"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,11,22]]},"references-count":40,"journal-issue":{"issue":"22","published-online":{"date-parts":[[2021,11]]}},"alternative-id":["jcm10225454"],"URL":"https:\/\/doi.org\/10.3390\/jcm10225454","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,11,22]]}}}