Effect of Fractional Microneedling Radiofrequency Versus Intralesional Steroid Injection With and Without Microneedling on Tissue Levels of PDGF & CTGF in Hypertrophic Scars: a Randomized Comparative Clinical Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Calculation of patient and observer scar assessment scale (POSAS) to assess change of hyertrophic scars
研究概览
简要总结
Comparing between the effect of Fractional Microneedling Radiofrequency Versus Intralesional Steroid Injection with and without Microneedling on Tissue levels of PDGF & CTGF in Hypertrophic Scars
详细描述
In each patient, each one of the two scars, or each side of a large scar will be assigned to one of the following treatment methods: 1-Fractional microneedling radiofrequency 2-Intralesional steroids injection. Scars treated with intralesional steroids will be subgrouped into two groups, one group treated with only intralesional steroids and the other group treated with intralesional steroids and followed by microneedling. Fractional microneedling radiofrequency parameters; Power: 6 v, Exposure time: 800 ms. Depth: 2.5 mm (using non-insulated micro-needles), Frequency: 2 Hz. For intralesional steroids injection, Triamcinolone acetonide will be injected in concentration 1:2 (20 mg/dl) using insulin syringe. Microneedling will be done using the same tip of the fractional microneedling radiofrequency at same depth. All patients will receive 5 treatment sessions 4 weeks apart.
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, Investigator)
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
- •Patients with mature hypertrophic scars.
- •Patients with age above 18 years.
- •Both males and females.
- •Patients with two separate lesions, each 3 cm length at least OR a large sized lesion 10 cm length at least.
排除标准
- •Patients with unrealistic expectations.
- •Patients with active skin infections or autoimmune diseases.
- •Non-compliant patients.
- •Patients who had received any form of treatment for scars during the last six months.
- •Recent use of isotretinoin within six months prior to the procedures.
- •Patient with known allergy to lidocaine.
- •Pregnancy & Lactation.
结局指标
主要结局
Calculation of patient and observer scar assessment scale (POSAS) to assess change of hyertrophic scars
时间窗: 6 months
Calculation of patient and observer scar assessment scale (POSAS) before every session and one month after the last session to clinically assess change of hyertrophic scars
Photographic documentation will be performed to assess change of hypertrophic scar(s)
时间窗: 6 months
Photographic documentation will be performed by obtaining digital photographs for hypertrophic scar(s) before every session and one month after the last session.
Measurement of tissue levels of both platelet derived growth factor (PDGF) & connective tissue growth factor (CTGF) to assess change of hypertrophic scars
时间窗: 6 months
Measurement of tissue levels of both PDGF \& CTGF to assess change of hypertrophic scars. Tissue levels of both PDGF \& CTGF will be measured by PCR in biopsies obtained from the scar areas before the treatment sessions and one month after the last session
次要结局
未报告次要终点
研究者
Maha Fathy Elmasry
principal investigator
Cairo University