Glutamine With Topical Corticosteroids for Lichen Planus Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-01-01

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.

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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.

Conditions

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Lichen Penis Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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conventional therapy

topical corticosteroid plus antifungal

Group Type ACTIVE_COMPARATOR

Miconazole Oral gel

Intervention Type DRUG

Miconazole oral gel: applied three to four times daily for three weeks

Kenacort in orabase

Intervention Type DRUG

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

Glutamine with a topical corticosteroid plus antifungal

Glutamine therapy in combination with a topical corticosteroid plus antifungal

Group Type EXPERIMENTAL

Glutamine Cap/Tab

Intervention Type DRUG

Glutamine Capsules: One capsule three times daily on an empty stomach for one month

Miconazole Oral gel

Intervention Type DRUG

Miconazole oral gel: applied three to four times daily for three weeks

Kenacort in orabase

Intervention Type DRUG

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

Interventions

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Glutamine Cap/Tab

Glutamine Capsules: One capsule three times daily on an empty stomach for one month

Intervention Type DRUG

Miconazole Oral gel

Miconazole oral gel: applied three to four times daily for three weeks

Intervention Type DRUG

Kenacort in orabase

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients clinically and histopathologically diagnosed to be suffering from EOLP.
2. Patients who had symptoms i.e. pain and/or burning sensation secondary to EOLP.
3. Patients under stressful life conditions as evidenced by ISMA-UK Stress Questionnaire
4. Males and Females with an age ranging from 30-60years

Exclusion Criteria

1. Patients suspected to have a lichenoid drug reaction or lichenoid contact allergy.
2. Patients suffering from any systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
3. Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No