Efficacy of Probiotic Capsules With Topical Clobetasol Propionate in OLP Treatment

Study Overview
=================
Brief Summary
-----------------
Oral lichen planus patients who will meet inclusion criteria will be divided into 2 groups -The intervention group (Group P): This group will be randomly allocated to take one capsule twice daily during meal time at morning and evening of probiotics complex obtained from Biovea for 4 -week study period. Moreover, patients in this group will be instructed to apply clobetasole propionate in orabase gel 2 times daily for 4 weeks. Patients will receive their supply of the gel and probiotics every 2 weeks. The control group (Group B): This group will be randomly allocated to apply clobetasol propionate in orabase gel 4 times daily after meal times and before sleeping for 4 weeks. At the 3rd week this group will be instructed to apply miconazole gel 4 times daily as a prophylaxis for two weeks. Salivary sample collection: Unstimulated salivary sample was collected from all participants twice , once at baseline and another time after 4 weeks from the study period. Saliva was collected in graduated clear test tubes to be used in the evaluation of candidal counts before and after treatment . Patient's visits was at baseline, 2 weeks and 4 weeks.

Official Title
-----------------
Evaluation of the Efficacy of Supplementary Probiotic Capsules With Topical Clobetasol Propionate 0.05% in the Treatment of Oral Lichen Planus

Conditions
-----------------
Oral Lichen Planus

Intervention / Treatment
-----------------
* Drug: Probiotic Blend Oral capsules
* Drug: Corticosteroids for Local Oral Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are diagnosed with symptomatic lichen planus whether bullous erosive or erythematous oral lichen planus. Male or female patient with age range between 20-75 years old were included. medically free individuals Exclusion Criteria: the use of systemic antibiotics, corticosteroids or immunosuppressive agents within four weeks prior to enrollment in the study. Pregnant females patients with history of systemic disorder affecting the immune system active liver diseases and cancer allergy or intolerance to probiotics. any other oral lesions

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: systemic probiotic (A)<br>Systemic probiotic capsules will be given twice daily in addition to topical application of topical clobetasol in orabase twice daily | Drug: Probiotic Blend Oral capsules<br>* probtiotic bend oral tablets from biovia will be adminestrated containing 4 strains ( twice daily) in addition to topical clobetasol application twice daily<br>Drug: Corticosteroids for Local Oral Treatment<br>* topical clobetasol probionate in orabase application 4 times daily<br>* Other names: clobetasol probionate in orabase;|
| Active Comparator: topical corticosteroid (B)<br>topical clobetasol in orabse application will be given 4 times daily ( 3 times after meals and once before bed time) prophylactic topical antifungal will be given in the fourth week to prevent candidal infection | Drug: Corticosteroids for Local Oral Treatment<br>* topical clobetasol probionate in orabase application 4 times daily<br>* Other names: clobetasol probionate in orabase;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| size wound | thongprasom scale | 0 , 2 weeks and 4 weeks | 
| Pain in oral cavity | Numerical rating scale (0-10) 0= minimal pain 10 unbearable pain | 0 , 2 weeks and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| candidal load assessment | culturing technique in CFU unit | 0 and 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral lichen planus, probiotics, clobetasol probionate