Efficacy of Topical Glucosamine Versus Corticosteroid in Oral Lichen Planus

Future University in Egypt36 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Oral Lichen Planus

Interventions

Glucosamine HydrochlorideDRUG

GlcN.H is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan known for its immunoregulatory capacity and anti-inflammatory effects.

Triamcinolone AcetonideDRUG

Topical corticosteroid (triamcinolone acetonide is a synthetic corticosteroid with potent anti-inflammatory, anti-allergic, and immunosuppressive properties which is used commonly in topical formulations)

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Clinical score (CS)

"0" represented no lesion/normal mucosa; "1" mild white striae/no erythematous area, "2"white 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

Time frame: Change from Baseline at 12 weeks

Secondary Outcomes

TNF-α

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

Time frame: Change from baseline at 8 weeks