Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus

Overview

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.

Full Title of Study: “Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus: A Pilot, Randomized, Clinical and Immunohistochemical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 2016

Detailed Description

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.

Interventions

  • Drug: Glucosamine sulfate
    • Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect
  • Drug: triamcinolone acetonide
    • Topical corticosteroid

Arms, Groups and Cohorts

  • Experimental: Glucosamine/Corticosteroid 4
    • Topical steroid (triamcinolone acetonide 0.1 %) four times per day and (glucosamine sulfate 500 mg) orally three times per day for 8 weeks
  • Experimental: Glucosamine/Corticosteroid 2
    • Topical steroid (triamcinolone acetonide 0.1 %) twice per day and (glucosamine sulfate 500 mg) orally three times per day for 8 weeks
  • Active Comparator: Corticosteroid
    • Topical steroid (triamcinolone acetonide 0.1 %) four times per day for 8 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Clinical score
    • 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 Measures

  • IKK-alpha
    • Time Frame: change from baseline at 8 weeks
    • Inhibitor kappa kinase alpha immunopositive cells count in immunostained section

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ola Mohamed Ezzatt, Lecturer of oral medicine and periodontology – Ain Shams University
  • Overall Official(s)
    • Hala A. Abo el ela, Professor, Study Director, Faculty of dentistry- Ain shams University

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