Efficacy of Topical Glucosamine Versus Corticosteroid in Oral Lichen Planus

NCT07114016 | Completed Phase 4 DMC

• 1 other identifier: FDASU-REC0787
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Oral Lichen Planus

Keywords

GlcN.H

Outcome Measures

Primary Outcomes (1)

• 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

  Change from Baseline at 12 weeks

Secondary Outcomes (1)

• TNF-α

  Change from baseline at 8 weeks

Other Outcomes (5)

• Visual Analogue Scale (VAS)

  Change from Baseline at 12 weeks

• TSA

  Change from Baseline at 12 weeks

• TUA

  Change from Baseline at 12 weeks

Study Arms (2)

Glucosamine

EXPERIMENTAL

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

Drug: Glucosamine Hydrochloride

Corticosteroids

ACTIVE COMPARATOR

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

Drug: Triamcinolone Acetonide

Interventions

Glucosamine Hydrochloride 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.

Glucosamine

Triamcinolone Acetonide 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)

Corticosteroids

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinically proven painful bullous/erosive or atrophic forms of OLP
• Histopathologically proven bullous/erosive or atrophic forms of OLP

You may not qualify if:

• 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

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

FUE

New Cairo, 4740011, Egypt

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Glucosamine; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Nevine H Kheir El Din, Prof.

  Faculty of Dentistry-ASU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Oral Medicine, Periodontology and Oral Diagnosis

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 11, 2025
• Study Start: May 1, 2023
• Primary Completion: May 15, 2025
• Study Completion: July 31, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: One year
• Access Criteria: Accessibility for oral medicine researchers

Locations

EG (1)