Clinical Trial: Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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 Summary: 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.
Sponsor: Ain Shams University

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: IKK-alpha [ Time Frame: change from baseline at 8 weeks ]

Inhibitor kappa kinase alpha immunopositive cells count in immunostained section


Original Secondary Outcome: Same as current

Information By: Ain Shams University

Dates:
Date Received: July 26, 2016
Date Started: May 2015
Date Completion:
Last Updated: August 3, 2016
Last Verified: August 2016