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OpenTrials
Completed

NCT Number: NCT04442633

Glutamine With Topical Corticosteroids for Lichen Planus Treatment

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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Key information

Conditions

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glutamine Cap/Tab

Drug

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

Miconazole Oral gel

Drug

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

Kenacort in orabase

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

Primary outcomes

  1. Change in oral lichen planus lesions severity

    Time frame: 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 outcomes

  1. Change in pain level

    Time frame: at baseline, 1 months and 3 months

    Pain score score 0= no pain score 1= mild score 2= moderate score 3= severe

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 22, 2020
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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