Glutamine With Topical Corticosteroids for Lichen Planus Treatment

Study Overview
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Brief Summary
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Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Glutamine promotes protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa structure.

Detailed Description
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Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Recently, increased oxidative stress has been implicated in the pathogenesis of erosive oral lichen planus (EOLP). Glutamine is a source of energy for fibroblasts, immunocompetent cells, and intestinal epithelial cells involved in collagen production. It promotes protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa structure. The aim of this study is to evaluate the effect of Glutamine combined with topical corticosteroid in the treatment of oral erosive LP. Thirty patients with a confirmed clinical and histopathologic diagnosis of OLP recruited in this study and divided into 2 equal groups, each consisting of 15 subjects. Group 1 consists of patients treated with topical steroids plus antifungal (conventional therapy); Group 2 consists of patients treated with Glutamine combined with topical steroids plus antifungal.

Official Title
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Clinical Evaluation of Glutamine Combined With Topical Corticosteroids in the Treatment of Erosive Oral Lichen Planus

Conditions
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Lichen Penis Planus

Intervention / Treatment
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* Drug: Glutamine Cap/Tab
* Drug: Miconazole Oral gel
* Drug: Kenacort in orabase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients clinically and histopathologically diagnosed to be suffering from EOLP. Patients who had symptoms i.e. pain and/or burning sensation secondary to EOLP. Patients under stressful life conditions as evidenced by ISMA-UK Stress Questionnaire Males and Females with an age ranging from 30-60years Exclusion Criteria: Patients suspected to have a lichenoid drug reaction or lichenoid contact allergy. Patients suffering from any systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction) Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional therapy<br>topical corticosteroid plus antifungal | Drug: Miconazole Oral gel<br>* Miconazole oral gel: applied three to four times daily for three weeks<br>Drug: Kenacort in orabase<br>* Kenacort in orabase: applied two to three times a day for 3 weeks followed by tapering the following 9 weeks until a maintenance dose of two to three times a week is reached<br>|
| Experimental: Glutamine with a topical corticosteroid plus antifungal<br>Glutamine therapy in combination with a topical corticosteroid plus antifungal | Drug: Glutamine Cap/Tab<br>* Glutamine Capsules: One capsule three times daily on an empty stomach for one month<br>Drug: Miconazole Oral gel<br>* Miconazole oral gel: applied three to four times daily for three weeks<br>Drug: Kenacort in orabase<br>* Kenacort in orabase: applied two to three times a day for 3 weeks followed by tapering the following 9 weeks until a maintenance dose of two to three times a week is reached<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in oral lichen planus lesions severity | Mucosal lesion severity score 0: no lesion score 1: white lesion score 2:atrophy/erosion intermixed or not with white lesion score 3: ulceration intermixed or not with white lesion | at baseline, 1 months and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain level | Pain score score 0= no pain score 1= mild score 2= moderate score 3= severe | at baseline, 1 months and 3 months |