Micronutrients in Management of Symptomatic Oral Lichen Planus

Study Overview
=================
Brief Summary
-----------------
Treatment of oral lichen planus is challenging. Diverse therapeutic modalities have been suggested, but a permanent cure is not yet available. In some OLP patients, topical corticosteroid alone is not sufficiently enough, thus it may require a supplementation to augment its effect. Micronutrients are gaining more attention as therapeutic modalities in immunologic disorders. Researchers are recommended to conduct further clinical studies are to assess the role of these elements in management of OLP (Gholizadeh & Sheykhbahaei, 2020). Among the less visited micronutrients are zinc and vitamin D. This trial will assess their role in management of OLP.

Detailed Description
-----------------
The enrolled patients will be divided randomly into three groups. One group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily, the second group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic zinc (Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma) twice daily and the third group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic vitamin D (Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals) once daily. The patients will be recalled weekly for eight weeks. For every four weeks of topical corticosteroid application, topical oral antifungal (Daktarin 2% oral gel - miconazole) will be prescribed, four times daily for one week, to all the patients in the trial, to avoid secondary infection with oral candidiasis. The patients will be asked to prohibit the use of any topical or systemic medication during the trial.

Official Title
-----------------
Evaluation of Micronutrients With Topical Corticosteroid Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Three-arm Randomized Clinical Trial

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

Intervention / Treatment
-----------------
* Dietary Supplement: Zinc sulphate heptahydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from erosive or atrophic OLP Patients free from any visible oral lesions other than OLP. Patients who agreed to take the supplied interventions. Patient who will agree to participate in the study. Patients who will accept to sign the informed consent. Exclusion Criteria: Patients suffering from any systemic disease. Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks. Treatment with any oral topical medications for at least four weeks prior to the study. Pregnant and lactating mothers.
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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical Corticosteroid with Systemic Zinc.<br>Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma | Dietary Supplement: Zinc sulphate heptahydrate<br>* Dietary supplements<br>* Other names: Cholecalciferol: vitamin D3 oral solution;|
| Active Comparator: Topical Corticosteroid with Systemic Vitamin D<br>Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals | Dietary Supplement: Zinc sulphate heptahydrate<br>* Dietary supplements<br>* Other names: Cholecalciferol: vitamin D3 oral solution;|
| Other: Topical Corticosteroid<br>Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm | Dietary Supplement: Zinc sulphate heptahydrate<br>* Dietary supplements<br>* Other names: Cholecalciferol: vitamin D3 oral solution;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity | Visual analogue scale (0-10) | baseline (week 0), daily in week 1, week 1,week 2, week 3, week 4, week 5, week 6 and week 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in clinical improvement | measured using Thongprasom et al. scoring system | baseline (week 0), week 1,week 2, week 3, week 4, week 5, week 6 and week 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
micronutrients, topical corticosteroids