The Effect of Ethosomal Gel Bearing Losartan 5% on The Patient and Observer Scar Assessment Scale Score, Degree of Erythema and Pigmentation, Surface Area, Thickness and Pliability of Human Keloids
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The patient and observer scar assessment scale score (POSAS 3.0)
研究概览
简要总结
The objectives are to compare the efficacy of pre and post-treatment and between 5% losartan potassium loaded in ethosomal gel and 10 mg/ml triamcinolone acetonide injection based on the indicator score of The patient and observer scar assessment scale 3.0 (POSAS 3.0), degree of erythema and pigmentation, area size, thickness and density of human keloids.
详细描述
After being informed about the study and the associated risks and benefits, participants will be randomly allocated to one of two groups, each consisting of 23 individuals. After being informed about the study and the associated risks and benefits, participants will be randomly allocated to one of two groups, each consisting of 23 individuals. One group will receive the topical application of 5% losartan gel, while the other will receive an injection of triamcinolone acetonide 10mg/ml. After being informed about the study and the associated risks and benefits, participants will be randomly allocated to one of two groups, each consisting of 23 individuals. To measure the subjective and objective changes that occur in the keloid before and after treatment, outcome assessors will be blinded. Measurements will be taken four times over the course of three months.
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)
盲法说明
The treatment given to participants is not known by any of the outcome assessors.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •keloid patients who came to the outpatient clinic of general hospital Syafira Pekanbaru during 2023-2024,
- •age is greater than or equal to 18 year
- •keloid scar than or equal to 25 cm2
- •duration of keloids longer than or equal to 6 months
- •no drug interventions or not currently on keloid medications for the last two months.
排除标准
- •subjects who do not understand the rubric of The patient and observer scar assessment scale (POSAS) and were not willing to participate
- •subjects with nodular keloids
- •subjects within antihypertensive therapy, pregnancy, malignancy, history of allergies, active skin lesions or bleeding in the keloid area.
- •subjects in the treatment of keloid within the last month.
研究组 & 干预措施
Losartan
ethosomal gel bearing losartan 5% applied two times a day for three consecutive months on keloids
干预措施: Ethosomal gel bearing losartan 5% (Drug)
Triamcinolone
Intralesional injection of triamcinolone acetonide 10 mg/ml every two weeks for three consecutive months on keloid
干预措施: triamcinolone acetonide 10 mg/ml (Drug)
结局指标
主要结局
The patient and observer scar assessment scale score (POSAS 3.0)
时间窗: change from baseline the POSAS score at 4,8, and 12 weeks, consecutively.
The Patient and Observer Scar Assessment Scale 3.0 consists of sixteen items of the patient questionnaire (PSAS) with maximum and minimum values are 80 and 16, consecutively; and seven items of the observer questionnaire (OSAS) with maximum and minimum values are 35 and 7, consecutively. The lower score, the better result of the keloid.
次要结局
- Degree of erythema and hyperpigmentation(change from baseline the degree of erythema and hyperpigmentation at 4, 8 and 12 weeks, consecutively.)
- the width of the keloid surface area (mm2)(change from baseline width of keloid surface area at 4, 8 and 12 weeks, consecutively.)
- The thickness of keloid (mm)(change from baseline thickness of keloid at 4, 8 and 12 weeks, consecutively.)
- The degree of pliability of keloid (durometer unit)(change from baseline pliability at 4, 8 and 12 weeks, consecutively.)
研究者
Yuni Eka Anggraini
Candidate of Doctor
Gadjah Mada University