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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucosamine | Experimental | (Topical glucosamine hydrochloride 1%) Four times per day for 8 weeks |
|
| Corticosteroids | Active Comparator | Topical steroid (triamcinolone acetonide 0.1 %) four times per day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from baseline at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) | 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 | Change from Baseline at 12 weeks |
| TSA |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nevine H Kheir El Din, Prof. | Faculty of Dentistry-ASU | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FUE | New Cairo | 4740011 | Egypt |
Age, gender and the number of the participants
One year
Accessibility for oral medicine researchers
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| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
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| ID | Term |
|---|---|
| D005944 | Glucosamine |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |
| D014221 | Triamcinolone |
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| 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) |
|
Total area of the marker lesion (mm2)
| Change from Baseline at 12 weeks |
| TUA | Surface area of ulcer in marker lesion (mm2) | Change from Baseline at 12 weeks |
| TAA | Surface area of atrophic areas in marker lesion (mm2) | Change from Baseline at 12 weeks |
| TPA | Surface area of papular areas in marker lesion (mm2) | Change from Baseline at 12 weeks |
| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011245 |
| Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |