Glutamine With Topical Corticosteroids for Lichen Planus Treatment

Not Applicable

Completed

• Conditions: Lichen Penis Planus
• Interventions: Drug: Miconazole Oral gel; Drug: Glutamine Cap/Tab; Drug: Kenacort in orabase

• Registration Number: NCT04442633
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2019-08-01
• Study Completion: 2020-01-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-19
• Last Update Submitted: 2020-06-19
• Study First Posted: 2020-06-22
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glutamine with a topical corticosteroid plus antifungal	Kenacort in orabase	Glutamine therapy in combination with a topical corticosteroid plus antifungal
conventional therapy	Kenacort in orabase	topical corticosteroid plus antifungal
conventional therapy	Miconazole Oral gel	topical corticosteroid plus antifungal
Glutamine with a topical corticosteroid plus antifungal	Glutamine Cap/Tab	Glutamine therapy in combination with a topical corticosteroid plus antifungal
Glutamine with a topical corticosteroid plus antifungal	Miconazole Oral gel	Glutamine therapy in combination with a topical corticosteroid plus antifungal

Primary Outcome Measures

Name	Time	Method
Change in oral lichen planus lesions severity	at baseline, 1 months and 3 months	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

Secondary Outcome Measures

Name	Time	Method
Change in pain level	at baseline, 1 months and 3 months	Pain score score 0= no pain score 1= mild score 2= moderate score 3= severe

Trial Locations

Locations (1)

Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt; 🇪🇬 Alexandria, Egypt