Lichen Penis Planus
Conditions
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.
Interventions
DRUGGlutamine Cap/Tab
Glutamine Capsules: One capsule three times daily on an empty stomach for one month
DRUGMiconazole Oral gel
Miconazole oral gel: applied three to four times daily for three weeks
DRUGKenacort 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
Sponsors
Hams Hamed Abdelrahman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in oral lichen planus lesions severity | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in pain level | at baseline, 1 months and 3 months | Pain score score 0= no pain score 1= mild score 2= moderate score 3= severe |
Countries
Egypt
Outcome results
None listed