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

McCaughey, Cort; Machan, M.A.; Bennett, Ralph; Zone, John J.; Hull, Christopher M.

doi:10.1111/j.1468-3083.2010.03923.x

Cited by 36 publications

(54 citation statements)

References 61 publications

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“…An another study, McCaughey et al (21) conducted a randomized, double-blind study involving 21 patients with OLP and found that pimecrolimus 1% cream was superior to vehicle cream in reducing mean investigator's global assessment, pain, and erosion size after 6 weeks of treatment. Pimecrolimus levels were detected in 9 out of the 10 treated patients, with a maximum level of 0.814 ng/mL.…”

Section: Discussionmentioning

confidence: 99%

The Effectiveness of Topical Pimecrolimus in the Treatment of Oral Lichen Planus

Mülayim¹,

Öztürk²,

Uzun³

2016

tdd

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Objectives: Oral lichen planus (OLP) is a chronic inflammatory disorder of unknown etiology that affects the skin and the mucosa, especially the oral mucosa. Several therapeutic agents have been investigated for the treatment of OLP. All agents used in the OLP therapy are palliative. Potent topical steroids are used as the conventional therapy for OLP. Since side-effects or steroid resistance may be encountered, alternative treatments may be necessary. This study aimed to evaluate the efficacy and safety of the topical pimecrolimus in the treatment of OLP. Methods: Seventeen patients with OLP were recruited into this study. Topical pimecrolimus 1% cream was applied twice a day to the affected areas. Patients were followed up for 3-6 months. Photographs of the lesions were taken and analyzed for areas of ulceration, erythema, and reticulation in every clinical examination. Results: We found that topical pimecrolimus 1% cream was an effective treatment for OLP. Two patients could not complete the treatment protocol because of the side effects such as local irritation and nausea. Conclusion: Topical pimecrolimus may be a valuable second treatment choice for patients with steroid-related side-effects or steroid-resistant OLP. However further randomized controlled studies have to be conducted to compare conventional treatment of topical corticosteroid with topical pimecrolimus. Keywords: Oral lichen planus, pimecrolimus, calcineurin inhibitor, treatment, efficacy, safety Öz Abstract Amaç: Oral liken planus (OLP) deri ve mukozaları özellikle de oral mukozayı tutan, etiyolojisi bilinmeyen kronik enflamatuvar bir hastalıktır. OLP tedavisi için birkaç terapötik ajan araştırılmıştır. OLP'nin tedavisinde kullanılan bütün ajanlar palyatif etkilidir. OLP'nin geleneksel tedavisinde potent topikal steroidler kullanılır. Steroidlerin yan etkileri veya steroide direnç ile karşılaşılabileceğinden alternatif tedaviler gerekli olabilir. Bu çalışmada topikal pimekrolimusun OLP'nin tedavisindeki etkinliğini ve güvenirliğini değerlendirmek amaçlandı. Yöntemler: OLP'li 17 hasta çalışmaya alındı. Topikal pimekrolimus %1 krem etkilenmiş bölgelere günde 2 kez uygulandı. Hastalar 3-6 ay süreyle aylık olarak takip edildi. Her kontrolde lezyonların fotoğrafı çekilerek ülserasyon, eritem ve ağ yapısı gibi özellikleri değerlendirildi. Bulgular: Biz OLP'nin tedavisinde topikal %1 pimekrolimusu etkili bulduk. Çalışmaya alınan iki hasta bulantı hissi ve lokal irritasyon gibi yan etkiler nedeni ile tedavi protokolünü tamamlayamadı. Sonuç: Topikal pimekrolimus, steroid ile ilişkili yan etkileri olan hastalarda veya steroide dirençli OLP'nin tedavisinde ikinci seçenek olarak düşünülebilir. Ancak etkinliği tam olarak değerlendirebilmek için OLP'nin geleneksel tedavisi olan topikal steroid ile topikal pimekrolimusun karşılaştırmalı, randomize, kontrollü çalışmaları yapılmalıdır.

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Section: Discussionmentioning

confidence: 99%

The Effectiveness of Topical Pimecrolimus in the Treatment of Oral Lichen Planus

Mülayim¹,

Öztürk²,

Uzun³

2016

tdd

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“…Twelve trials compared an active intervention with placebo: cyclosporine [3], clobetasol & miconazole [19], curcuminoids as an adjunct to prednisone [18], pimecrolimus [17,24,33], aloe vera [21,30], hyaluronic acid [26], ignatia [25], lycopene [32] & MuGard [37]. There was no evidence of difference in mean pain score after treatment between active intervention & placebo in three trials [18,19,30].…”

Section: Effects Of Interventions Active Intervention Vs Placebomentioning

confidence: 99%

“…Six studies [14,15,17,18,24,33] performed intention-to-treat (ITT) analyses. Of these, except Yoke and Gorouhi, the rest enrolled only erosive oral lichen planus [14,15].…”

Section: Incomplete Outcome Datamentioning

confidence: 99%

“…Tel Aviv San Francisco scale was used in one trial [32]. Erythema was measured on a 0-3 scale and size of target erosion in mm in one study [33] and Net Clinical Score was used in another study [35]. The erosive area was measured in mm 2 using a calibrated dental probe in one trial and unblinded by all authors and any disagreement was resolved through discussion and consensus.…”

Section: Secondarymentioning

confidence: 99%

“…Topical tacrolimus was used in four trials [13,22,23,35], topical pimecrolimus in four trials [15,17,24,33], topical cyclosporine in four trials [3,5,14,16].…”

Section: Study Characteristicsmentioning

confidence: 99%

See 2 more Smart Citations

Medical Management of Oral Lichen Planus: A Systematic Review

Suresh

Krunal²,

Desai³

et al. 2016

JCDR

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Interventions for treating oral lichen planus: corticosteroid therapies

Lodi

Manfredi

Mercadante

et al. 2020

Cochrane Database of Systematic Reviews

100

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Background Oral lichen planus (OLP) is a relatively common chronic T cell-mediated disease, which can cause significant pain, particularly in its erosive or ulcerative forms. As pain is the indication for treatment of OLP, pain resolution is the primary outcome for this review. This review is an update of a version last published in 2011, but focuses on the evidence for corticosteroid treatment only. A second review considering non-corticosteroid treatments is in progress. Objectives To assess the e ects and safety of corticosteroids, in any formulation, for treating people with symptoms of oral lichen planus. Search methods Cochrane Oral Health's Information Specialist searched the following databases to 25 February 2019: Cochrane Oral Health's Trials Register, CENTRAL (2019, Issue 1), MEDLINE Ovid, and Embase Ovid. ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. There were no restrictions on language or date of publication. Selection criteria We considered randomised controlled clinical trials (RCTs) of any local or systemic corticosteroid treatment compared with a placebo, a calcineurin inhibitor, another corticosteroid, any other local or systemic (or both) drug, or the same corticosteroid plus an adjunctive treatment. Data collection and analysis Three review authors independently scanned the titles and abstracts of all reports identified, and assessed risk of bias using the Cochrane tool and extracted data from included studies. For dichotomous outcomes, we expressed the estimates of e ects of an intervention as risk ratios (RR), with 95% confidence intervals (CI). For continuous outcomes, we used mean di erences (MD) and 95% CI. The statistical unit of analysis was the participant. We conducted meta-analyses only with studies of similar comparisons reporting the same outcome measures. We assessed the overall certainty of the evidence using GRADE. Main results We included 35 studies (1474 participants) in this review. We assessed seven studies at low risk of bias overall, 11 at unclear and the remaining 17 studies at high risk of bias. We present results for our main outcomes, pain and clinical resolution measured at the end of Interventions for treating oral lichen planus: corticosteroid therapies (Review)

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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

Abstract: Pimecrolimus 1% cream was superior to vehicle in reducing pain, erythema, decreasing erosion size, and improving overall severity of disease when compared with vehicle treatment.

Cited by 36 publications

References 61 publications

The Effectiveness of Topical Pimecrolimus in the Treatment of Oral Lichen Planus

The Effectiveness of Topical Pimecrolimus in the Treatment of Oral Lichen Planus

Medical Management of Oral Lichen Planus: A Systematic Review

Interventions for treating oral lichen planus: corticosteroid therapies

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