Oral Lichen Planus
Conditions
Keywords
GlcN.H
Brief summary
Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan. It is classified as a nutraceutical and it is used mainly orally for the therapy of osteoarthritis since GlcN has immunoregulatory capacity and anti-inflammatory effects. Given the Oral lichen planus (OLP) T-cell-mediated pathogenesis; this drug seems to be a promising therapeutic option. The investigators compared the clinical efficacy of topical glucosamine to topical corticosteroid in the treatment of symptomatic OLP and investigated the effect of these two treatment modalities on the expression of tumor necrosis factor-alpha (TNF-α) in oral lichen planus lesions
Detailed description
Thirty-six patients with erosive or atrophic OLP were randomly assigned into Two equal groups to receive topical GlcN (glucosamine hydrochloride 1%) 4 times/day for 8 weeks (Group I) and topical steroid (triamcinolone acetonide 0.1 %) 4 times / day for 8 weeks (Group II). All patients were followed up for another 4 weeks (treatment free observational period). Photographs of the most severe lesion were taken (Marker lesion) in each patient and analyzed for total surface area (TSA), total ulcerative area (TUA), total atrophic area (TAA), and total papular area (TPA), patients were also assessed using clinical scores (CS) and visual analogue scale (VAS). Pre-treatment and post-treatment specimens were immunohistochemically analyzed to detect expression of TNF-α.
Interventions
GlcN.H is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan known for its immunoregulatory capacity and anti-inflammatory effects.
DRUGTriamcinolone Acetonide
Topical corticosteroid (triamcinolone acetonide is a synthetic corticosteroid with potent anti-inflammatory, anti-allergic, and immunosuppressive properties which is used commonly in topical formulations)
Sponsors
Future University in Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Clinically proven painful bullous/erosive or atrophic forms of OLP * Histopathologically proven bullous/erosive or atrophic forms of OLP
Exclusion criteria
* Lichenoid lesions. * Presence of systemic conditions * Smoking. * Hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation as mentioned in medical history. * Pregnancy or breast-feeding. * Presence of skin lesions. * History of previous treatments potentially effective on OLP. * Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus. * Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites. * Refusing to participate in the study. * Vulnerable groups
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical score (CS) | Change from Baseline at 12 weeks | 0 represented no lesion/normal mucosa; 1 mild white striae/no erythematous area, 2white striae with atrophic area less than 1 cm², 3 white striae with atrophic area more than 1 cm², 4 white striae with erosive area less than 1 cm², and 5 white striae with erosive area more than 1 cm² |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TNF-α | Change from baseline at 8 weeks | TNF-α is a highly pleiotropic multifunctional cytokine. It plays a prominent role in host defense and immune responses to infection, influences remodeling of tissue, angiogenesis stimulation and takes part in regulation of cell proliferation and differentiation. It has been known as an important mediator of cancer |
Other
| Measure | Time frame | Description |
|---|---|---|
| TUA | Change from Baseline at 12 weeks | Surface area of ulcer in marker lesion (mm2) |
| Visual Analogue Scale (VAS) | Change from Baseline at 12 weeks | Patients ranked the severity of pain on 10-cm visual analogue scale from (0 to10) where 0 represented no pain to 10 represented the worst pain |
| TPA | Change from Baseline at 12 weeks | Surface area of papular areas in marker lesion (mm2) |
| TAA | Change from Baseline at 12 weeks | Surface area of atrophic areas in marker lesion (mm2) |
| TSA | Change from Baseline at 12 weeks | Total area of the marker lesion (mm2) |
Countries
Egypt
Outcome results
None listed