Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus: A Pilot, Randomized, Clinical and Immunohistochemical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Clinical score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically and Histologically proven painful Bullous/erosive or atrophic forms of OLP
排除标准
- •lichenoid lesions
- •Presence of systemic conditions
- •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
研究组 & 干预措施
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
干预措施: Glucosamine sulfate (Drug)
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
干预措施: triamcinolone acetonide (Drug)
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
干预措施: Glucosamine sulfate (Drug)
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
干预措施: triamcinolone acetonide (Drug)
Corticosteroid
Topical steroid (triamcinolone acetonide 0.1 %) four times per day for 8 weeks
干预措施: triamcinolone acetonide (Drug)
结局指标
主要结局
Clinical score
时间窗: 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
次要结局
- IKK-alpha(change from baseline at 8 weeks)
研究者
Ola Mohamed Ezzatt
Lecturer of oral medicine and periodontology
Ain Shams University