Botulinum Toxin Versus Mesotherapy on Enhancement of Facial Scarring (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in scar appearance
研究概览
简要总结
Most of the body's tissues can undergo wound repair following a disruption of tissue integrity. Upon healing, these wounds result in scar formation. The scars widen when the overlying musculature pulls apart suture lines. Botulinum Toxin A (BTA) is known to prevent fibroblast proliferation and it also induces temporary muscle paralysis. Also, mesotherapy is the non-invasive transdermal injection which can aid the skin to increase collagen and elastin production. Thus, both techniques are eligible for enhancement of facial scars.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffering from vertical or oblique forehead lacerations caused by trauma.
- •Recent and fresh wounds.
- •Atrophic scar (linear scar).
排除标准
- •Infected wound.
- •Patient on chemotherapy treatment and history of malignancy.
- •Patients suffering from burns on the forehead or complicated lacerations.
- •Allergy to drugs used in this study
结局指标
主要结局
Change in scar appearance
时间窗: Baseline, 1 month, 3 months, 6 months
The Vancouver Scar Scale (VSS) will be measured to calculate scar appearance. The VSS evaluates four indicators: vascularity, pigmentation, pliability, and height. It has a score ranging from 0-13. * Vascularity: Normal 0, Pink 1, Red 2, Purple 3 * Pigmentation: Normal 0, Hypopigmentation 1, Hyperpigmentation 2 * Pliability: Normal 0, Supple 1, Yielding 2, Firm 3, Ropes 4, Contracture 5 * Height: Flat (0), \< 2 mm (1), 2-5 mm (2), \> 5 mm (3)
Change in wound width
时间窗: Baseline, 1 month, 3 months, 6 months
The mean wound width will be measured using a graduated Vernier caliper
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Assistant Lecturer of Dental Public Health and biostatistical consultanat
Alexandria University