Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars)
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Patient and Observer Scar Assessment Scale (POSAS)
研究概览
简要总结
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids and hypertrophic Scars)
详细描述
On a yearly basis, millions develop different skin scarring. These scars are a public reminder of the traumatic incident, past or present disease or a surgery which caused them.
Scarring is a common consequence of wound healing process, and it is one of the most complex biological processes in human. This healing process is affected by numerous factors and thus can be disrupted, leading to pathological scarring.
Pathological scarring is common in people with genetic predisposition, those undergone complex and massive surgeries, burns or those wounded in unsanitary environments. Apart from being aesthetically unpleasant, scars are associated with functional and psychosocial morbidities.
Despite clinical, pathologic and pathogenic differences between keloids and hypertrophic scars, treatments are similar.
Scars have a negative external impact causing social distress and impaired self-image, and as a consequence, low satisfaction rates following surgical and cosmetic procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 participants with at least 4 keloids
- •20 participants with a hypertrophic scar of at least 11 cm length
排除标准
- •current or planned pregnancy
- •breastfeeding women
- •participants suffering from diabetes mellitus or coagulation disorders
- •infection at planned injection sites
- •systemic treatment of corticosteroids, 5-fluorouracil
- •known allergy to any of the following: Betamethasone acetate + Betamethasone sodium phosphate, Triamcinolone acetonide, Dexamethasone sodium phosphate, Methylprednisolone acetate
研究组 & 干预措施
keloids
each patient will be injection by all 4 steroids for comparison patients with 4 or more keloids will be injection with each steroid for different keloid
干预措施: Betamethasone acetate + Betamethasone sodium phosphate (Drug)
keloids
each patient will be injection by all 4 steroids for comparison patients with 4 or more keloids will be injection with each steroid for different keloid
干预措施: Dexamethasone sodium phosphate (Drug)
keloids
each patient will be injection by all 4 steroids for comparison patients with 4 or more keloids will be injection with each steroid for different keloid
干预措施: Methylprednisolone acetate (Drug)
keloids
each patient will be injection by all 4 steroids for comparison patients with 4 or more keloids will be injection with each steroid for different keloid
干预措施: Triamcinolone acetonide (Drug)
hypertrophic scars
each patient will be injection by all 4 steroids for comparison patients with a 11 cm hypertrophic scar will be injected by all 4 steroids along the scar with a 1 cm distance between each steroid
干预措施: Betamethasone acetate + Betamethasone sodium phosphate (Drug)
hypertrophic scars
each patient will be injection by all 4 steroids for comparison patients with a 11 cm hypertrophic scar will be injected by all 4 steroids along the scar with a 1 cm distance between each steroid
干预措施: Dexamethasone sodium phosphate (Drug)
hypertrophic scars
each patient will be injection by all 4 steroids for comparison patients with a 11 cm hypertrophic scar will be injected by all 4 steroids along the scar with a 1 cm distance between each steroid
干预措施: Methylprednisolone acetate (Drug)
hypertrophic scars
each patient will be injection by all 4 steroids for comparison patients with a 11 cm hypertrophic scar will be injected by all 4 steroids along the scar with a 1 cm distance between each steroid
干预措施: Triamcinolone acetonide (Drug)
结局指标
主要结局
Patient and Observer Scar Assessment Scale (POSAS)
时间窗: 6 months post last treatment, data will be reported through study completion an average of 1 year
For the Observer Scar Assessment Scale (OSAS), the investigators score the following parameters of each part of the scar on a scale ranging from 1 (normal skin) to 10 (worst scar imagin¬able): 'vascularization', 'pigmentation', 'thickness', 'relief', and 'pliability'. The total score on the OSAS is the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst). For the patient scar assessment scale (PSAS), the participants used a scale of 1 to 10 to answer questions relating to pain, itching, color, stiffness, irregularity and thickness. The total score on the PSAS was the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst)
次要结局
- 3D camera(6 months post last treatment, data will be reported through study completion an average of 1 year)
- Visual analogue scale (pain scale)(at each of the three treatment appointments, data will be reported through study completion an average of 1 year)
- Dermatologist's assessment(6 months post last treatment, data will be reported through study completion an average of 1 year)
- Participant's assessment(6 months post last treatment, data will be reported through study completion an average of 1 year)