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NCT Number: NCT07114016

Efficacy of Topical Glucosamine Versus Corticosteroid in Oral Lichen Planus

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

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Key information

Conditions

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

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

FUE

New Cairo, 4740011, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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)

Primary outcomes

  1. Clinical score (CS)

    Time frame: Change from Baseline at 12 weeks

    "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

Secondary outcomes

  1. TNF-α

    Time frame: 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 outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 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

  2. TSA

    Time frame: Change from Baseline at 12 weeks

    Total area of the marker lesion (mm2)

  3. TUA

    Time frame: Change from Baseline at 12 weeks

    Surface area of ulcer in marker lesion (mm2)

  4. TAA

    Time frame: Change from Baseline at 12 weeks

    Surface area of atrophic areas in marker lesion (mm2)

  5. TPA

    Time frame: Change from Baseline at 12 weeks

    Surface area of papular areas in marker lesion (mm2)

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

Efficacy of Topical Glucosamine Versus Corticosteroid on Tumor Necrosis Factor -Alpha Induced Apoptosis in Oral Lichen Planus: A Randomized Controlled Clinical Trial With Immunohistochemical Analysis

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 11, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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