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
|
|
Primary Sponsor
|
Name |
PGIMER |
Address |
PGIMER, Sector-12, Chandigarh |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
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
|
|
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. |