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CTRI Number  CTRI/2018/11/016448 [Registered on: 28/11/2018] Trial Registered Prospectively
Last Modified On: 21/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Is use of combination of Acitretin capsule and topical triamcinolone gel better than triamcinolone gel alone in treatment of lichen planus of mouth. 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Keshavamurthy Vinay 
Designation  Assistant Professor 
Affiliation  PGIMER (Postgraduate Institute of Medical Education and Research) 
Address  Department of Dermatology, Venereology and Leprology PGIMER, Sector-12

Chandigarh
CHANDIGARH
160012
India 
Phone  8872993222  
Fax    
Email  vinay.keshavmurthy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Keshavamurthy Vinay 
Designation  Assistant Professor 
Affiliation  PGIMER (Postgraduate Institute of Medical Education and Research) 
Address  Department of Dermatology, Venereology and Leprology PGIMER, Sector-12

Chandigarh
CHANDIGARH
160012
India 
Phone  8872993222  
Fax    
Email  vinay.keshavmurthy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Keshavamurthy Vinay 
Designation  Assistant Professor 
Affiliation  PGIMER (Postgraduate Institute of Medical Education and Research) 
Address  Department of Dermatology, Venereology and Leprology PGIMER, Sector-12

Chandigarh
CHANDIGARH
160012
India 
Phone  8872993222  
Fax    
Email  vinay.keshavmurthy@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  PGIMER 
Address  PGIMER, Sector-12, Chandigarh 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Keshavamurthy Vinay  Postgraduate Institute of Medical Education and Research (PGIMER)  Department of Dermatology, Venereology and Leprology, PGIMER, Sector-12, Chandigarh
Chandigarh
CHANDIGARH 
8872993222

vinay.keshavmurthy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K121||Other forms of stomatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1  Patients will be treated with acitretin in a dose of 25 mg daily in case of body weight 60 kg or less, or 35 mg daily in case of body weight more than 60 kg . Topical triamcinolone acetonide (0.1%) oral paste will also be applied locally on the lesions thrice a day. 
Comparator Agent  Group 2  Patients in group II will receive oral custom-manufactured placebo capsules (similar in appearance as oral acitretin tablets) along-with topical triamcinolone acetonide (0.1%) oral paste for local application three times daily. Use of topical anaesthetic preparations and antiseptic mouth washes & gargles will be allowed in both the groups as and when required. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients with symptomatic oral lichen planus.
2. Age - 18 years or more
 
 
ExclusionCriteria 
Details  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 ⁄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.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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.
 
36 weeks 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Lichen  planus (LP)  is  a chronic inflammatory mucocutaneous  disease of unknown etiopathogenesis.  Oral mucosa is the  most  commonly involved site followed by skin,  the  vulvar  and  vaginal  mucosa,  glans  penis,  scalp  , and  nails.   Oral LP (OLP) can present as the sole clinical manifestation of the disease or may be associated with cutaneous or other mucosal involvement including the genital area, gastrointestinal tract, and eyes.The estimated worldwide prevalence of oral lichen planus have been found to be ranging from 0.22% to 5 % in different studies, affecting females more than males. The prevalence of oral lichen planus in an Indian study was found to be 2.6%.  The symptomatology of OLP ranges from painless lesions to painful erosive and ulcerative lesions.    

OLP is known to have several clinical subtypes including reticular, erosive, atrophic, papular, plaque-like, and bullous subtypes. Reticular variant, which presents as plaques with interlacing white keratotic lines and surrounded by an erythematous border is the most common subtype. Reticular OLP usually involves  the buccal mucosa, gingiva and sometimes tongue, palate, and lips and is mostly asymptomatic.  Symptoms like burning sensation and pain is usually associated with erosive, atrophic or bullous variants of OLP. Symptomatic oral lichen planus is a painful and debilitating condition having a significant impact over the quality of life of the patient.

Treatment of oral lichen planus can be challenging especially in cases of refractory and extensive disease. The goal of therapy is healing of erosions and improvements in symptoms so that patients can 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, mycophenolate mofetil,  CO2  laser,  thalidomide,  and  low-molecular-weight  heparin,  etc.

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

Systemic acitretin, which is a commonly used modality for treatment for cutaneous lichen planus have also been found to have significant improvement in OLP in a recent case series and a placebo-controlled trial conducted primarily to evaluate the efficacy of acitretin in cutaneous lichen planus. However, there is paucity of robust evidence in favour of the use of systemic acitretin either as monotherapy or in combination with topical corticosteroids in oral lichen planus. The proposed study is aimed to compare the combination of systemic acitretin and topical triamcinolone with placebo and topical triamcinolone in oral lichen planus. This will be a placebo controlled trial where recruited patients of oral lichen planus will be randomized to either of the two intervention groups. The patients and the investigator evaluating the treatment response will both be blinded. This study is an attempt to fill the gap in literature regarding the evidence for the use of systemic acitretin in oral lichen planus.

 
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