Efficacy of Topical Glucosamine Versus Corticosteroid in Oral Lichen Planus

NCT ID: NCT07114016

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-07-31

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.

Conditions

Oral Lichen Planus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Glucosamine

(Topical glucosamine hydrochloride 1%) Four times per day for 8 weeks

Group Type: EXPERIMENTAL

Glucosamine Hydrochloride

Intervention Type: DRUG

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

Corticosteroids

Topical steroid (triamcinolone acetonide 0.1 %) four times per day for 8 weeks

Group Type: ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type: DRUG

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

Interventions

Glucosamine Hydrochloride

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

Intervention Type: DRUG

Triamcinolone 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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Future University in Egypt

OTHER

Sponsor Role: lead

Responsible Party

Sara Abd El-Halim Galala

Assistant Lecturer of Oral Medicine, Periodontology and Oral Diagnosis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nevine H Kheir El Din, Prof.

Role: STUDY_DIRECTOR

Faculty of Dentistry-ASU

Locations

FUE

New Cairo, , Egypt

Countries

Egypt

Other Identifiers

FDASU-REC0787

Identifier Type: -

Identifier Source: org_study_id