Effectiveness and safety of Microneeding Fractional Radiofrequency (MnRF) and Microneedling Fractional Radiofrequency (MnRF) with platelet rich plasma therapy (PRP) in the Treatment of Striae Distensae-A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Clinical assessment of improvement of striae according to Global Aesthetic Improvement Scale (GAIS), SDA scoring scale by a side by side comparison of Pre-operative and post-operative photographs taken at every visit and at the end of 4 weeks and 12weeks after the last session.
研究概览
简要总结
Patients will be randomized into 2 groups – group A and group B
➢ Group A – 32 patients - MnRF given for striae once in 4 weeks for 4 sittings.
Group B – 32 patients – MnRF with PRP given for striae once in 4 weeks for 4 sittings
Type of randomization & method used- The sample shall be randomized according to a computer generated algorithm.
Blinding - Assessor blinding
Brief procedure
GROUP A – PROCEDURE
• Prior to each treatment session, clinical photographs will be taken. PRILOX cream (Lignocaine 2.5% and Prilocaine 2.5%) will be applied to the targeted regions of striae distensae for 40 min followed by gentle cleansing.
• The procedure area will be painted with povidine iodine and cleaned with 70% isopropyl alcohol as a disinfectant, using sterile precautions.
• Patients with striae distensae will be subjected to receiving four sequential microneedling radiofrequency sessions with an interval of 4 weeks between each session. The energy delivery system consists of a disposable tip with 25-89 gold-plated insulated microneedle electrodes(depending of the dimensions of the striae) with a maximum energy output of 50 W. The depth of the needle can be adjusted from a minimum of 0.5 mm to a maximum of 3.5 mm.
• In each session, two passes will be administered.
• Disposable micro radiofrequency needles will be used for every patient in each session.
• Post procedure, the sites will be wiped gently with cold water and an ice pack was applied for 5 min to alleviate discomfort and minimize swelling.
• Patients will be advised to apply emollients.
• Any post procedure erythema persisting for more than 3 days will be treated with topical steroid cream.
GROUP B – PROCEDURE
• In addition to the above mentioned procedure, PRP will be injected intralesionally.
• Process of extracting PRP: Double spin – Open method
ASSESSMENT
Clinical assessment by a blinded assessor of the improvement of striae according to Global Aesthetic Improvement Scale (GAIS), SDA scoring scale, adverse effects by a side by side comparison of Pre-operative and post-operative photographs taken at every visit and at the end of 4 weeks and 12weeks after the last session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All Patients above 18 years of age attending SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE Dermatology OPD, diagnosed with striae distensae.
- •Patients willing to refrain from all other oral and topical medications for striae distensae.
- •Patients providing voluntary informed and written consent for the explained treatment modality to be performed.
排除标准
- •Patients who have received treatment for SD in the past 3 months.
- •Pregnant and lactating women.
- •Patients with active infections at the site.
- •Patients with history of photosensitive disorders like lupus erythematosus, dermatomyositis.
- •Patients with history of propensity for keloid formation and vitiligo.
结局指标
主要结局
Clinical assessment of improvement of striae according to Global Aesthetic Improvement Scale (GAIS), SDA scoring scale by a side by side comparison of Pre-operative and post-operative photographs taken at every visit and at the end of 4 weeks and 12weeks after the last session.
时间窗: Week 0, 4, 8, 12, 16, 24
次要结局
- Patient satisfaction score at the end of the study(24th week)
研究者
Varshini N R
SRM Medical College Hospital and Research Centre