Glutamine With Topical Corticosteroids for Lichen Planus Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Lichen Penis Planus
• Intervention / Treatment: Drug: Miconazole Oral gel; Drug: Kenacort in orabase; Drug: Glutamine Cap/Tab

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional therapy; topical corticosteroid plus antifungal	Drug: Miconazole Oral gel; Miconazole oral gel: applied three to four times daily for three weeks; 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
Experimental: Glutamine with a topical corticosteroid plus antifungal; Glutamine therapy in combination with a topical corticosteroid plus antifungal	Drug: Miconazole Oral gel; Miconazole oral gel: applied three to four times daily for three weeks; 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; Drug: Glutamine Cap/Tab; Glutamine Capsules: One capsule three times daily on an empty stomach for one month

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Miconazole
• Other Study ID Numbers: Glutamine and lichen planus

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No