Pimecrolimus vs. tacrolimus for the topical treatment of unresponsive oral erosive lichen planus: a 8 week randomized double‐blind controlled study

Abstract

This is an author version of the contribution published on:Questa è la versione dell 'autore dell'opera: J Eur Acad Dermatol Venereol. 2014 Apr;28(4):475-82. doi: 10.1111/jdv.12128 Design An 8-week randomized, double-blind controlled trial, followed by a six-month follow-up period.Setting Outpatients of the Oral Medicine Section, Lingotto Dental School, University of Turin, Italy.Patients Thirty patients were treated with either pimecrolimus 1% cream or tacrolimus 0.1% ointment, both mixed with an equivalent amount of 4% hydroxyethyl cellulose gel. InterventionThe medications were to be applied twice daily for 2 months as follow: finger rub application on dried lesions after meals without eating, drinking or speaking for at least half an hour afterwards. Each patient was examined at the beginning of therapy, and then every two weeks during the treatment and every 3 months of follow-up. Main Outcome Measures (i)To compare the effectiveness of topically applied pimecrolimus and tacrolimus; (ii) to evaluate which is more cost-effective; (iii) to determine which drug is faster in reducing signs and symptoms and (iv) which gives the longest remission.Results Both drugs were effective at inducing clinical improvement, with no statistical difference. Pimecrolimus creams revealed a significantly better stability of the therapeutic effectiveness (P=.031). ConclusionBoth medications would currently appear to be a treatment of choice for patients with unresponsive atrophic-erosive OLP. Pimecrolimus seemed to be more effective in providing long-term resolution of sings and symptoms. Future efforts are however needed to obtain more objective evidence of the benefit of these medications in the treatment of immunologically mediated oral mucosal lesion.

Clinical and serological efficacy of topical calcineurin inhibitors in oral lichen planus: a prospective randomized controlled trial

“…However, it did not necessitate discontinuation of therapy and did not affect compliance in any of the two groups. This side effect has been reported in previous studies as well . Other side effects such as objectionable taste of the ointment, intermittent headache, and pigmentation reported with the tacrolimus application were not observed in our study.…”

“…To date, a single clinical trial involving 30 patients has compared the efficacy of topical tacrolimus 0.1% ointment and pimecrolimus 1% cream in OLP . Both the study drugs were mixed with 4% hydroxyethyl cellulose gel for twice‐daily application for eight weeks.…”

Efficacy of topical tacrolimus for oral lichen planus: real‐life experience in a retrospective cohort of patients with a review of the literature

“…After the same therapy period Malik et al . found a CR in 11 of 20 (55%) cases, while Arduino et al . described that 33% of patients had almost complete improvement.…”

“…OLP often constitutes a therapeutic challenge. Although many therapeutic options are available, their effectiveness is not constant . More importantly, the methodological quality of the available interventions is of relatively low quality.…”

“…Some authors reported reduction of VAS score for pain only in percentage . Arduino et al . described an improvement of symptoms at week 8 in almost all 15 patients treated by tacrolimus.…”