Glutamine With Topical Corticosteroids for Lichen Planus Treatment

NCT04442633 | Completed

• 1 other identifier: Glutamine and lichen planus
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lichen Penis Planus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in pain level

  at baseline, 1 months and 3 months

Study Arms (2)

conventional therapy

ACTIVE COMPARATOR

topical corticosteroid plus antifungal

Drug: Miconazole Oral gel; Drug: Kenacort in orabase

Glutamine with a topical corticosteroid plus antifungal

EXPERIMENTAL

Glutamine therapy in combination with a topical corticosteroid plus antifungal

Drug: Glutamine Cap/Tab; Drug: Miconazole Oral gel; Drug: Kenacort in orabase

Interventions

Glutamine Cap/Tab DRUG

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

Glutamine with a topical corticosteroid plus antifungal

Miconazole Oral gel DRUG

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

Glutamine with a topical corticosteroid plus antifungal; conventional therapy

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

Glutamine with a topical corticosteroid plus antifungal; conventional therapy

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

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

Alexandria, Egypt

Location

MeSH Terms

Interventions

Triamcinolone; Orabase

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: April 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: January 1, 2020
• Last Updated: June 22, 2020

Record last verified: 2020-06

Locations

EG (1)