Comparing Microneedling With Phenytoin to Microneedling Alone for the Treatment of Striae Alba
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in INA score of striae alba between treatment sides
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of Microneedling with Phenytoin versus Microneedling alone for the Treatment of Striae alba.The study is a comparative study which will be carried on 30 patients with Striae alba. Each patient will receive four sessions three weeks apart of the following treatment: -Right side: striae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. -Left side: striae on the left side will be treated by microneedling alone with depth (2 mm) .
The follow up will be during each session and 1 months after the last session. For treated striae alba, Microneedling will be done under aseptic conditions using isopropyl alcohol 70%.
详细描述
The aim of this study is to evaluate the efficacy and safety of Microneedling with Phenytoin versus Microneedling alone for the Treatment of Striae alba.The study is a comparative study which will be carried on 30 patients with Striae alba. Each patient will receive four sessions three weeks apart of the following treatment: -Right side: striae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. -Left side: striae on the left side will be treated by microneedling alone with depth (2 mm) .
The follow up will be during each session and 1 months after the last session. For treated striae alba, Microneedling will be done under aseptic conditions using isopropyl alcohol 70%.
All Patients will be evaluated during each session and 1 month after the last session.
All patients in this study will be subjected to the following:
- Written informed consent will be obtained from all patients after informing them about the steps of the procedures, the expected effects, the possible complications, other alternative treatments, and the importance of photo documentation.
- Full history taking:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stria alba.
- •The patient's age ≥18 years.
- •Both sex male and Femal patients
- •At least 3 stria
排除标准
- •Pregnancy or lactation.
- •Keloid or hypertrophic scar tendency
- •Active skin infection at treatment site
- •Use of isotretinoin within the past 6 months
- •Bleeding disorders or anticoagulant therapy
- •History of hypersensitivity to phenytoin
- •Chronic systemic diseases affecting wound healing (e.g., uncontrolled diabetes)
- •Previous striae treatment within the last 6 months
- •Unrealistic expectations or poor compliance
- •Premalignant or malignant lesions in the treatment area
研究组 & 干预措施
Micro needling +Topical Phenytoin
striae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. A 2% Phenytoin topical solution will be prepared by dissolving the accurate amount of Phenytoin sodium in purified water using a magnetic stirrer. 15% propylene glycol will be added to this solution as a cosolvent and a viscosity modifier. The formulation will be stirred using magnetic stirring up to complete dissolving. Finally, the prepared solution will be dispensed in an amber-colored glass bottle.
干预措施: Micro needling (Device)
Micro needling alone
striae on the left side will be treated by microneedling alone with depth (2 mm).
干预措施: Micro needling (Device)
Micro needling +Topical Phenytoin
striae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. A 2% Phenytoin topical solution will be prepared by dissolving the accurate amount of Phenytoin sodium in purified water using a magnetic stirrer. 15% propylene glycol will be added to this solution as a cosolvent and a viscosity modifier. The formulation will be stirred using magnetic stirring up to complete dissolving. Finally, the prepared solution will be dispensed in an amber-colored glass bottle.
干预措施: Phenytoin (Drug)
结局指标
主要结局
Change in INA score of striae alba between treatment sides
时间窗: baseline (before Session 1) and Week 9 (after completion of Session 4)
Change in the INA score of striae alba from baseline to after completion of the four treatment sessions for each treatment side. The change in INA score will be compared between the right side treated with micro needling plus topical phenytoin and the left side treated with micro needling alone.,
Change in INA score of striae Alba between treatment sides.
时间窗: Baseline (before Session 1), and 1 month after the last treatment session(weak 13).
\- The change in (INA) score of striae alba from baseline and 1 month after the last session for each treatment side. The change in INA score will be compared between the right side treated with microneedling plus topical phenytoin and the left side treated with microneedling alone.
次要结局
- Change in pain score(During each treatment session at Baseline (before Session 1), Week 3 (before Session 2), Week 6 (before Session 3), and Week 9 (before Session 4).)
- Change in Patient Satisfaction (PS) Score(Baseline, after treatment at fourth session(weak 9) , and 1 month after the last treatment session(weak13).)
研究者
Doaa Hamza Mahmoud Elbery
Dermatology Resident
Al-Azhar University