Glutamine With Topical Corticosteroids for Lichen Planus Treatment

Lichen Penis Planus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04442633
• Other study ID #: Glutamine and lichen planus
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: June 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 1, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lichen Penis Planus
• Lichen Planus

Intervention

Drug:
• Glutamine Cap/Tab
Glutamine Capsules: One capsule three times daily on an empty stomach for one month
• Miconazole Oral gel
Miconazole oral gel: applied three to four times daily for three weeks
• 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

Locations

Country	Name	City	State
Egypt	Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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