Back to resultsGlutamine With Topical Corticosteroids for Lichen Planus Treatment
Primary Purpose
Lichen Penis Planus
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Glutamine Cap/Tab
Miconazole Oral gel
Kenacort in orabase
Sponsored by
About this trial
This is an interventional treatment trial for Lichen Penis Planus
Eligibility Criteria
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.
Sites / Locations
- Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
conventional therapy
Glutamine with a topical corticosteroid plus antifungal
Arm Description
topical corticosteroid plus antifungal
Glutamine therapy in combination with a topical corticosteroid plus antifungal
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in pain level
Pain score score 0= no pain score 1= mild score 2= moderate score 3= severe
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04442633
Brief Title
Glutamine With Topical Corticosteroids for Lichen Planus Treatment
Official Title
Clinical Evaluation of Glutamine Combined With Topical Corticosteroids in the Treatment of Erosive Oral Lichen Planus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Penis Planus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional therapy
Arm Type
Active Comparator
Arm Description
topical corticosteroid plus antifungal
Arm Title
Glutamine with a topical corticosteroid plus antifungal
Arm Type
Experimental
Arm Description
Glutamine therapy in combination with a topical corticosteroid plus antifungal
Intervention Type
Drug
Intervention Name(s)
Glutamine Cap/Tab
Intervention Description
Glutamine Capsules: One capsule three times daily on an empty stomach for one month
Intervention Type
Drug
Intervention Name(s)
Miconazole Oral gel
Intervention Description
Miconazole oral gel: applied three to four times daily for three weeks
Intervention Type
Drug
Intervention Name(s)
Kenacort in orabase
Intervention Description
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 Outcome Measure Information:
Title
Change in oral lichen planus lesions severity
Description
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
Time Frame
at baseline, 1 months and 3 months
Secondary Outcome Measure Information:
Title
Change in pain level
Description
Pain score score 0= no pain score 1= mild score 2= moderate score 3= severe
Time Frame
at baseline, 1 months and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
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Glutamine With Topical Corticosteroids for Lichen Planus Treatment
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