Efficacy of Topical Glucosamine Versus Corticosteroid in Oral Lichen Planus

Future University in Egypt

Status and phase

Completed

Phase 4

Conditions

Oral Lichen Planus

Treatments

Drug: Glucosamine Hydrochloride

Drug: Triamcinolone Acetonide

Study type

Interventional

Funder types

Other

Identifiers

NCT07114016

FDASU-REC0787

Details and patient eligibility

About

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

Full 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.

Enrollment

36 patients

Sex

All

Ages

25 to 60 years old

Volunteers

No Healthy Volunteers

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