Efficacy of Topical Glucosamine Versus Corticosteroid on Tumor Necrosis Factor -Alpha Induced Apoptosis in Oral Lichen Planus: A Randomized Controlled Clinical Trial With Immunohistochemical Analysis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Clinical score (CS)
研究概览
简要总结
Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan. It is classified as a nutraceutical and it is used mainly orally for the therapy of osteoarthritis since GlcN has immunoregulatory capacity and anti-inflammatory effects. Given the Oral lichen planus (OLP) T-cell-mediated pathogenesis; this drug seems to be a promising therapeutic option. The investigators compared the clinical efficacy of topical glucosamine to topical corticosteroid in the treatment of symptomatic OLP and investigated the effect of these two treatment modalities on the expression of tumor necrosis factor-alpha (TNF-α) in oral lichen planus lesions
详细描述
Thirty-six patients with erosive or atrophic OLP were randomly assigned into Two equal groups to receive topical GlcN (glucosamine hydrochloride 1%) 4 times/day for 8 weeks (Group I) and topical steroid (triamcinolone acetonide 0.1 %) 4 times / day for 8 weeks (Group II). All patients were followed up for another 4 weeks (treatment free observational period). Photographs of the most severe lesion were taken (Marker lesion) in each patient and analyzed for total surface area (TSA), total ulcerative area (TUA), total atrophic area (TAA), and total papular area (TPA), patients were also assessed using clinical scores (CS) and visual analogue scale (VAS). Pre-treatment and post-treatment specimens were immunohistochemically analyzed to detect expression of TNF-α.
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
- Double (Participant, 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 proven painful bullous/erosive or atrophic forms of OLP
- •Histopathologically proven bullous/erosive or atrophic forms of OLP
排除标准
- •Lichenoid lesions.
- •Presence of systemic conditions
- •Hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation as mentioned in medical history.
- •Pregnancy or breast-feeding.
- •Presence of skin lesions.
- •History of previous treatments potentially effective on OLP.
- •Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus.
- •Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.
- •Refusing to participate in the study.
- •Vulnerable groups
研究组 & 干预措施
Glucosamine
(Topical glucosamine hydrochloride 1%) Four times per day for 8 weeks
干预措施: Glucosamine Hydrochloride (Drug)
Corticosteroids
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 (CS)
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
- TNF-α(Change from baseline at 8 weeks)
研究者
Sara Abd El-Halim Galala
Assistant Lecturer of Oral Medicine, Periodontology and Oral Diagnosis
Future University in Egypt