A Observer Blind Randomized Controlled Pilot Trial to Determine the Equivalence of a Silicone Gel With Superoxidized Water vs. a Pirfenidone Gel for the Treatment of Hypertrophic Scars and Keloids
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Dermatology Life Quality Index Score
研究概览
简要总结
Justification:
Keloid scars are a major medical and cosmetic problem, especially in darker skin types that predominate in Mexico. It is estimated that hypertrophic scars affecting from 1.5 to 4.5% of the general population. However, the exact prevalence is unknown but studies show that going from 32 to 67%. And there are studies documenting that this prevalence is higher in Hispanic and black individuals and in the pediatric population.
Keloid scars can become highly symptomatic disfiguring and which affects the quality of life of patients and their self-esteem.Problem Statement:
Is silicone gel solutions superoxidation with equal or better than the gel 8% pirfenidone to treat keloids and hypertrophic scars?
Goal:
To evaluate the efficacy of a silicone gel-oxidation with solutions compared to a gel containing 8% pirfenidone.
Hypothesis:
If the silicone gel solutions superoxidation is equal or better than gel 8% pirfenidone to treat keloids and hypertrophic scars, then the reduction in the ECV and the EVA will be similar in the first group than the second.
Design:
Comparative, observer blind, experimental and prospective study.
详细描述
This is a comparative, non-inferiority, experimental, prospective, longitudinal pilot study with blind evaluator, in patients with keloid or hypertrophic scars. Twenty patients per group randomly assigned to receive identical tubes of either a silicone-based gel with superoxidized water, or an 8% pirfenidone gel. Follow-up was scheduled at 2, 4, 8, 12, and 16 weeks recording the location, mechanism of the scar, time of evolution, skin phototype, accompanying symptoms, Dermatology Life Quality Index, and validated scar assessment tools (Patient and Observer Scar Assessment Scale, Vancouver Scar Scale, and the Analog Visual Scale for Keloids).
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)
盲法说明
Tubes containg both active treatments were identical. Outcomes assessor was blinded to treatment arm.
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
- •keloid or hypetrophic scar
排除标准
- •collagen diseases pregnancy previous treatment for 3 months
研究组 & 干预措施
Topical Silicone Gel
A gel containing silicone
干预措施: silicon gel (Drug)
Topical Pirfenidone Gel
A gel containing pirfenidone
干预措施: pirfenidone 8% gel (Drug)
结局指标
主要结局
Dermatology Life Quality Index Score
时间窗: 3 months
A life quality index for dermatological conditions
Patient and Observer Scar Assessment Scale Score
时间窗: 3 months
A validated scale (POSAS and OSAS) to assess relevant clinical characteristics of scars.
Vancouver Scar Scale
时间窗: 3 months
A validated scar scale
次要结局
未报告次要终点