Efficacy and Safety of Topical Nano Preparation of Phenytoin Plus Fractional CO2 Laser Versus Fractional CO2 Laser Alone for Treatment of Atrophic Post Acne Scars: A Randomized Split Face Study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- To assess the Quantitative Global Acne Scarring score before.
研究概览
简要总结
To evaluate the efficacy and safety of topical phenytoin spanlastics as an adjuvant therapy in treatment of atrophic post acne scars.
To compare the efficacy of topical phenytoin spanlastics combined with fractional co2 laser versus fractional co2 laser alone in treatment of atrophic post acne scars.
详细描述
Acne is one of the most dermatological problems in the world which causes scars as secondary damage .
It affects the appearance and psychology of the patient badly . There are three main types of scars: atrophic, hypertrophic, or keloidal depending on a loss (atophic) or gain (hypertrophic and keloidal) of collagen .
Atrophic scars presented in the form of icepick, rolling and poxscar . It is a challenge to mange atrophic scars because these scars result from tissue loss during the healing after severe acne. There are many therapeutic techniques that continuously evolving for management of these scars as: fractional lasers, microneedling, chemical peels and dermabrasion .
Phenytoin (PHT) is the main treatment for epilepsy. However, many patients who took it show gingival hyperplasia . Phenytoin causes increased fibroblasts proliferation. It has the ability to reduce the oedema and inflammation at the wound base and margins, early separation of slough, and collagen production and acceleration of growth of healthy granulation tissues, so it can be used in healing .
By induction of collagen synthesis and reducing inflammation, topical phenytoin can alleviate the appearance of atrophic scars including acne scars and improve their texture. Application of phenytoin directly to affected areas may lead to significant improvements in scarred skin over regular and consistent usage .
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 (Participant)
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
- •Patients aged equal or more than 18 years old with atrophic post acne scars.
排除标准
- •Pregnancy and lactation
- •Hypertrophic scars
- •Kidney, liver, neurological, haematological, malignant or immunosuppressive diseases.
- •Active infection at the site of the scars
- •Patients use medications that reduced tissue healing during the study or in a period less than one month ago (immunosuppressants and isotretinoin).
- •Patients who are taking anticoagulants or NSAIDS within the past 48h.
研究组 & 干预措施
Topical Phenytoin and Fractional CO2 laser
Topical Phenytoin and Fractional CO2 laser will be used in combinaton to treat atrophic post-acne scars.
干预措施: Topical nano preparation of Phenytoin (Drug)
Fractional CO2 laser alone
Fractional CO2 laser will be used alone to treat atrophic post acne scars.
干预措施: Fractional CO2 laser (Device)
结局指标
主要结局
To assess the Quantitative Global Acne Scarring score before.
时间窗: Immediately at the end of the treatment and 2 months after the end of the treatment
* The Quantitative Global Scarring Grading System uses a scale of 0 to 84 * The scale assesses the severity of scarring based on the appearance, depth, and area of the scars.
次要结局
未报告次要终点
研究者
Shaimaa Mohamed Abdalla Sultan
Dermatologist resident
Assiut University
