Evaluating the Effectiveness and Safety of Microneedling With Topical Tranexamic Acid in Treatment of Striae Rubra; Asplit Body Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical improvement in striae rubra
研究概览
简要总结
This study aims to evaluate the efficacy and safety of microneedling with topical tranexamic acid versus microneedling with placebo (normal saline) in the treatment of striae rubra.
One side of the affected area (the intervention side) will receive topical tranexamic acid at a concentration of 100 mg/mL (Kapron® ampoules, 500 mg/5 mL; Amoun Pharmaceutical Co.), followed by a microneedling session.
The contralateral side (the control side) will receive a placebo-specifically, 0.9% normal saline-followed by a microneedling session performed in the same manner as on the intervention side.
Treatment sessions will be conducted every three weeks-up to a maximum of five sessions, depending on the patient's clinical improvement-at weeks 0, 3, 6, 9, and 12, for a total treatment duration of 12 weeks
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 of both gender aged ≥18 years, clinically and dermoscopically diagnosed with bilateral symmetrical striae rubra (present on corresponding anatomical sites on both sides of the body with approximately symmetrical distribution and similar clinical appearance (color, width, and stage of evolution)). and willing to participate and sign informed consent
排除标准
- •• Striae alba.
- •Pregnancy or lactation.
- •History of keloids or hypertrophic scars.
- •Active skin infection in treatment area.
- •Patients using other modalities of treatment for over the last 3 months.
- •Patients with bleeding disorders or on anticoagulant therapy.
- •Patients using drugs that exacerbate the striae as systemic corticosteroids in the preceding 3 months or topical corticosteroid in the preceding one month.
研究组 & 干预措施
Microneedling plus topical tranexamic acid
Participants will receive microneedling followed by topical application of tranexamic acid to the affected striae rubra areas every 3 weeks for a maximum of five sessions.
干预措施: Topical tranexamic acid (Drug)
Microneedling plus topical normal saline
Participants will receive microneedling followed by topical application of normal saline to the affected striae rubra areas every 3 weeks for a maximum of five sessions
干预措施: normal saline (0.9% NaCl) (Other)
结局指标
主要结局
Clinical improvement in striae rubra
时间窗: At baseline and at weeks 3, 6, 9, and 12
quartile grading scale based on Physician's Global Assessment
Change in striae rubra severity assessed by Physician's Global Assessment-based quartile grading scale
时间窗: At baseline and at weeks 3, 6, 9, and 12
Striae rubra severity will be assessed using a Physician's Global Assessment-based quartile grading scale, expressed as percentage response. The scale ranges from 0% to 100%, with higher values indicating a better treatment response. Responses are categorized as poor response (\<25%), mild response (25-50%), moderate response (50-75%), and excellent response (\>75%).
次要结局
未报告次要终点
研究者
Hager Adel Mohamed
Dermatology Resident, Sohag General Hospital
Sohag University