A placebo controlled double blinded randomized controlled trial comparing the combination of oral acitretin and topical steroids with topical steroid monotherapy in symptomatic oral lichen planus

Lichen  planus (LP) is  a chronic inflammatorymucocutaneous  disease of unknownetiopathogenesis.  Oral mucosa isthe  most commonly involved site followed by skin, the  vulvar  and vaginal  mucosa,  glans penis,  scalp  , and nails.   OralLP (OLP) can present as the sole clinical manifestation of the disease or maybe associated with cutaneous or other mucosal involvement including the genitalarea, gastrointestinal tract, and eyes.The estimatedworldwide prevalence of oral lichen planus have been found to be ranging from0.22% to 5 % in different studies, affecting females more than males. The prevalence of oral lichen planus in an Indian study was found to be2.6%.  The symptomatology of OLP ranges frompainless lesions to painful erosive and ulcerative lesions.

OLP is known to have several clinical subtypesincluding reticular, erosive, atrophic, papular, plaque-like, and bulloussubtypes. Reticular variant, which presents as plaques with interlacing white keratoticlines and surrounded by an erythematous border is the most common subtype.Reticular OLP usually involves  thebuccal mucosa, gingiva and sometimes tongue, palate, and lips and is mostlyasymptomatic.  Symptoms like burning sensation and pain is usually associated witherosive, atrophic or bullous variants of OLP. Symptomatic orallichen planus is a painful and debilitating condition having a significantimpact over the quality of life of the patient.

Treatment of oral lichen planus can bechallenging especially in cases of refractory and extensive disease. The goalof therapy is healing of erosions and improvements in symptoms so that patientscan resume their usual eating habits and lifestyle.  Various  treatments have  been  employed to  treat  symptomatic OLP,  but  complete resolution  is  difficult to  achieve. The available  options  of treatment  of  OLP are  corticosteroids,  topical and  systemic  retinoids, calcineurin  inhibitors  (cyclosporin, tacrolimus, pimecrolimus), azathioprine,  phototherapy,  griseofulvin, hydroxychloroquine,  dapsone, mycophenolatemofetil,  CO2  laser, thalidomide,  and  low-molecular-weight  heparin, etc.

Topicalcorticosteroids remains the mainstay of treatment for oral lichen planus. Topical  corticosteroids  are preferred  over  systemic corticosteroids in OLP  owing totheir efficacy and lesser risk of serious adverse effects. Superpotent  halogenated steroids  clobetasol  propionate, triamcinolone  and  fluocinolone acetonide  have been  found  to be  effective.

Systemicacitretin, which is a commonly used modality for treatment for cutaneous lichenplanus have also been found to have significant improvement in OLP in a recentcase series and a placebo-controlled trial conducted primarily to evaluate theefficacy of acitretin in cutaneous lichen planus. However, there is paucity of robustevidence in favour of the use of systemic acitretin either as monotherapy or incombination with topical corticosteroids in oral lichen planus. The proposedstudy is aimed to compare the combination of systemic acitretin and topicaltriamcinolone with placebo and topical triamcinolone in oral lichen planus. Thiswill be a placebo controlled trial where recruited patients of oral lichenplanus will be randomized to either of the two intervention groups. Thepatients and the investigator evaluating the treatment response will both beblinded. This study is an attempt to fill the gap in literature regarding theevidence for the use of systemic acitretin in oral lichen planus.