Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus

Study Overview
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Brief Summary
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Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect and was administrated orally in osteoarthritis and atopic dermatitis therapy. Given the Oral lichen planus (OLP) T-cell-mediated pathogenesis; this drug seems to be a promising therapeutic option. The investigators compared clinical effectiveness of Glucosamine combined with two topical corticosteroid regimens to that of topical corticosteroid alone in symptomatic OLP and investigated therapeutic mechanism by examining treatment effect on expression of inhibitor kappa kinase alpha (IKKα) and interleukin-8 (IL-8) in OLP lesions.

Detailed Description
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Thirty patients with Erosive or Atrophic OLP were randomly assigned into Three equal groups to receive combination of topical steroid (triamcinolone acetonide 0.1 %) four times per day and (glucosamine sulfate 500 mg) orally three times per day for 8 weeks (Group I), combination of topical steroid twice daily and glucosamine sulfate 500 mg orally three times per day for 8 weeks (Group II), or topical steroid alone four times per day for 8 weeks (Group III) all patients were followed up for another treatment free 4 weeks observational period. Photographs of the most severe lesion were taken (Marker lesion) in each patient and analyzed for Total Ulcerative Area (TUA), Total Atrophic Area (TAA), and Total Reticular Area (TRA), patients were also assessed using clinical scores (CS) and visual analogue scale (VAS). Pre-treatment and post-treatment specimens were immunohistochemically stained to detect expression of IKKα and IL-8.

Official Title
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Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus: A Pilot, Randomized, Clinical and Immunohistochemical Trial

Conditions
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Oral Lichen Planus

Intervention / Treatment
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* Drug: Glucosamine sulfate
* Drug: triamcinolone acetonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically and Histologically proven painful Bullous/erosive or atrophic forms of OLP Exclusion Criteria: lichenoid lesions Presence of systemic conditions Smoking Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation Pregnancy or breast-feeding History of previous treatments potentially effective on OLP in last 3 months Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucosamine/Corticosteroid 4<br>Topical steroid (triamcinolone acetonide 0.1 %) four times per day and (glucosamine sulfate 500 mg) orally three times per day for 8 weeks | Drug: Glucosamine sulfate<br>* Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect<br>Drug: triamcinolone acetonide<br>* Topical corticosteroid<br>* Other names: Kenalog in orabase;|
| Experimental: Glucosamine/Corticosteroid 2<br>Topical steroid (triamcinolone acetonide 0.1 %) twice per day and (glucosamine sulfate 500 mg) orally three times per day for 8 weeks | Drug: Glucosamine sulfate<br>* Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect<br>Drug: triamcinolone acetonide<br>* Topical corticosteroid<br>* Other names: Kenalog in orabase;|
| Active Comparator: Corticosteroid<br>Topical steroid (triamcinolone acetonide 0.1 %) four times per day for 8 weeks | Drug: triamcinolone acetonide<br>* Topical corticosteroid<br>* Other names: Kenalog in orabase;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical score | 0 represented no lesion/normal mucosa; 1 mild white striae/no erythematous area, 2white 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKK-alpha | Inhibitor kappa kinase alpha immunopositive cells count in immunostained section | change from baseline at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral lichen planus, Glucosamine, IL-8