Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus
- Conditions
- Oral Lichen Planus
- Interventions
- Registration Number
- NCT02858297
- Lead Sponsor
- Ain Shams University
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Clinically and Histologically proven painful Bullous/erosive or atrophic forms of OLP
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glucosamine/Corticosteroid 4 Glucosamine sulfate Topical steroid (triamcinolone acetonide 0.1 %) four times per day and (glucosamine sulfate 500 mg) orally three times per day for 8 weeks Glucosamine/Corticosteroid 2 Glucosamine sulfate Topical steroid (triamcinolone acetonide 0.1 %) twice per day and (glucosamine sulfate 500 mg) orally three times per day for 8 weeks Glucosamine/Corticosteroid 4 triamcinolone acetonide Topical steroid (triamcinolone acetonide 0.1 %) four times per day and (glucosamine sulfate 500 mg) orally three times per day for 8 weeks Glucosamine/Corticosteroid 2 triamcinolone acetonide Topical steroid (triamcinolone acetonide 0.1 %) twice per day and (glucosamine sulfate 500 mg) orally three times per day for 8 weeks Corticosteroid triamcinolone acetonide Topical steroid (triamcinolone acetonide 0.1 %) four times per day for 8 weeks
- Primary Outcome Measures
Name Time Method Clinical score 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 Outcome Measures
Name Time Method IKK-alpha change from baseline at 8 weeks Inhibitor kappa kinase alpha immunopositive cells count in immunostained section