Is use of combination of Acitretin capsule and topical triamcinolone gel better than triamcinolone gel alone in treatment of lichen planus of mouth.

Not yet recruiting

Conditions: Other forms of stomatitis,

Registration Number: CTRI/2018/11/016448

Lead Sponsor: PGIMER

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 64

Inclusion Criteria

1.Patients with symptomatic oral lichen planus. 2.Age.
18 years or more.

Exclusion Criteria

1.Any active treatment for oral lichen planus (OLP) in preceding 4 weeks.
2.Presence of any contraindications for acitretin use such as a.pregnant and lactating women.
b.leucopenia with leucocyte count <4000 â„mm3 c.liver enzymes >2 times the upper limit of reference range d.Moderate to severe cholesterol and triglycerides elevation e.Deranged renal function test 3.Females of reproductive age group who have not completed their family or are not willing to use contraception as required.
4.Patients on any other immunosuppressive, immunomodulatory drugs or on drugs that has significant interaction with acitretin.
5.Dental filling with oral lichenoid reaction.
6.Patients who are unable to attend proposed regular follow-up visits.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Percentage of patients achieving greater than 75 % reduction (excellent response) in severity score at release from treatment and at the end of 8 weeks post release from treatment, as compared to baseline.	36 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage and absolute reduction in severity score and VAS at release from treatment and at the end of 8 weeks post release from treatment, as compared to baseline in both groups.	2.Percentage of patients achieving good, moderate or poor response based on reduction in severity scores at release from treatment and at the end of 8 weeks post release from treatment.

Trial Locations

Locations (1): Postgraduate Institute of Medical Education and Research (PGIMER)
🇮🇳
Chandigarh, CHANDIGARH, India
Postgraduate Institute of Medical Education and Research (PGIMER)
🇮🇳Chandigarh, CHANDIGARH, India
Keshavamurthy Vinay
Principal investigator
8872993222
vinay.keshavmurthy@gmail.com