| CTRI Number |
CTRI/2023/08/056156 [Registered on: 04/08/2023] Trial Registered Prospectively |
| Last Modified On: |
03/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To test the effectiveness of two commonly used medicines in Oral Lichen Planus and to study their molecular interactions. |
|
Scientific Title of Study
|
Evaluation of efficacy of topical 0.1% Triamcinolone acetonide and topical 0.1% Tacrolimus in the management of symptomatic Oral
Lichen Planus followed by In silico analysis- A randomized observer blinded clinical study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anupama Warrier |
| Designation |
Post Graduate student |
| Affiliation |
MGM Dental College and Hopital, Navi Mumbai |
| Address |
501, Department of Oral Pathology and Microbiology, MGM Dental College and Hospital
Junction of NH4 and, Sion - Panvel Hwy, Sector 18, Navi Mumbai, Maharashtra 410209
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9986089946 |
| Fax |
|
| Email |
anu_warrier@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jigna Pathak |
| Designation |
Guide, Professor |
| Affiliation |
MGM Dental College and Hopital, Navi Mumbai |
| Address |
501, Department of Oral Pathology and Microbiology, MGM Dental College and Hospital, Junction of NH4 and, Sion - Panvel Hwy, Sector 18, Navi Mumbai, Maharashtra 410209
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9819175805 |
| Fax |
|
| Email |
drjignapathak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jigna Pathak |
| Designation |
Guide, Professor |
| Affiliation |
MGM Dental College and Hopital, Navi Mumbai |
| Address |
501, Department of Oral Pathology and Microbiology, MGM Dental College and Hospital, Junction of NH4 and, Sion - Panvel Hwy, Sector 18, Navi Mumbai, Maharashtra 410209
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9819175805 |
| Fax |
|
| Email |
drjignapathak@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Dental College and Hospital,Junction of NH4 and, Sion - Panvel Hwy, Sector 18, Navi Mumbai, Maharashtra 410209 |
|
|
Primary Sponsor
|
| Name |
MGM Dental College and Hospital |
| Address |
Junction of NH4 and, Sion - Panvel Hwy, Sector 18, Navi Mumbai, Maharashtra 410209 |
| 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 |
| Dr Anupama Warrier |
MGM Dental College and Hospital |
Junction of NH4 and, Sion - Panvel Hwy, Sector 18, Navi Mumbai, Maharashtra 410209
Raigarh
MAHARASHTRA |
9986089946
anu_warrier@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MGM Dental College and Hospital, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tacrolimus |
Tacrolimus is a calcineurin inhibitor used as an ointment applied 4 times a day for 10 minutes and rinsed off for the treatment of Oral Lichen Planus |
| Intervention |
Triamcinolone acetonide
|
Triamcinolone acetonide is a corticosteroid used as an ointment applied 4 times a day for 10 minutes in the affected area and rinsed off . |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinico- histopathologically diagnosed cases of Oral Lichen
Planus.
1. Patients with symptoms of pain and burning sensation
secondary to Oral Lichen Planus.
2. Patients willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Topical or systemic medication for treatment of Oral Lichen Planus up to 4 weeks prior to the study
Histopathological examination with atypical or lichenoid
dysplastic features.
1. Patients with asymptomatic oral lesions.
2. Patients with other mucosal diseases.
3. Patients with history of any allergy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To check and compare the reduction in clinical signs and symptoms of Oral Lichen Planus on application of treatment agents during the course of followup
|
0,2,4,6,8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
14/08/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Oral Lichen Planus (OLP) is a chronic mucocutaneous, auto immune disease where the etiology remains unclear. The global prevalence of OLP is up to 2%. In India the prevalence is reported to be 2.6%.It affects women 2 to 3 times more commonly than men on average between the 30 to 70 years of age. OLP can be either asymptomatic or symptomatic, and when symptomatic, can range from mild sensitivity to significant pain that impacts quality of life. The most involved sites are the buccal mucosa, borders and dorsum of the tongue and gingiva. The bilateral and symmetric distribution is typical of OLP. The hard and soft palate, lips, and floor of the mouth are rarely affected. Clinically OLP is characterized by lesions consisting of radiating white, grey, velvety, thread-like papules in a linear, annular and retiform arrangement. OLP can present itself in reticular, having characteristic Wickham striae, atrophic (erythematous) or erosive (ulcerative) forms. Patients with reticular lesions are often asymptomatic, but atrophic or erosive OLP is often associated with a burning sensation and pain.Pathogenesis of OLP is often associated with T cell mediated immunological dysfunction. Antigen-specific and nonspecific mechanisms are involved in the pathogenesis of OLP. The activated helper T cells produce IL-2 and interferon (IFN)-gamma and lead to the proliferation and activation of cytotoxic T lymphocytes, which cause the apoptosis of basal keratinocytes and the degeneration of basal epithelial cells. IL-17 activates a proinflammatory cascade that leads to recruitment of T lymphocytes. TNF-alpha is involved in the migration of T cells from the capillaries into the surrounding extracellular matrix. Management of OLP is aimed at reducing symptoms and the manifestation of lesions. The treatment modalities for OLP can be pharmacological treatment, non- pharmacological modalities or adjuvant therapy with phytochemicals. Pharmacological treatment includes topical or systemic corticosteroids, retinoid, dapsone, cyclosporine, calcinuerin inhibitors. Corticosteroids are most commonly used for the treatment of OLP because of their action in suppressing cell-mediated immune activity. They have anti-inflammatory properties that helps in reducing edema and lymphocytic exudation, prevents swelling and cell damage by inhibiting phagocytosis tissue damage and fibrosis. Topical corticosteroids effectively penetrate the squamous epithelium and have less severe side effects than systemic corticosteroids. Triamcinolone acetonide paste is the most widely available commercial corticosteroid for the treatment of OLP . Topical calcineurin inhibitors like cyclosporine, tacrolimus (TAC) or pimecrolimus are considered as an alternative to treat recalcitrant cases of OLP. Calcineurin inhibitors are immunomodulators that bind to intra-cytoplasmic proteins in T-lymphocytes which in turn inhibit calcineurin, leading to suppression of transcription and production of variable cytokines and suggesting a possible role of these agents in management of variable immune-mediated lesions Also recent systematic reviews and meta-analysis have concluded that topical tacrolimus is a safe and effective alternative to topical corticosteroids for OLP treatment.Tacrolimus inhibits mediators released from basophil and mast cell, along with that it stops activities for calcineurin phosphatase enzymes, which hinder formation and secretions of IL-2 and tumour necrosis factor α, finally inhibiting the multiplication of T cells.Several other therapeutic modalities have been used with varying efficacy which includes general measures (good oral hygiene, antibacterial mouthwash, and antifungal agents), psoralen plus ultraviolet A light (PUVA), griseofulvin, hydroxychloroquine and dapsone (1, 3). Also, ozone therapy, cryotherapy with nitrous oxide gas (NOG), photodynamic therapy (PDT), and low-level laser therapy (LLLT), also called photobiomodulation (PBM), have been proposed for patients with symptomatic OLP.Also trends toward drugs of natural or herbal origin like curcumin, aloe vera, honey, chamomile have been considered for the treatment of OLP. since phytochemicals have been found to possess potent anti-inflammatory, antioxidant and anti-carcinogenic properties. Understanding the pathogenesis of a condition is essential for targeted treatment and better prognosis. Being reproducible, in silico methods can serve as initial screening platforms for assessing the efficacy of drugs and drug repurposing through molecular docking. Through in silico analysis we will understand the interaction of drug at target site and co-relate this with its clinical outcome. Although a wide spectrum of therapeutic options are available for treatment of OLP, none are completely curative because of the recalcitrant nature and idiopathic etiology of the disease. Although first line of therapy for treating symptomatic OLP is corticosteroids, several alternative treatment modalities are also effective. Phytochemicals are also used as adjuvant therapy in cases of OLP. Thus, the aim of the present study is to compare the efficacy of topical 0.1% Triamcinolone acetonide and topical 0.1% Tacrolimus in the management of symptomatic Oral Lichen Planus and study their mode of action by in-silico analysis which can predict the types of targets these drug compounds (ligands) can bind efficiently to. This maybe clinically significant in targeted therapeutics and help explore the potential side effects resulting from off target intervention. |