Fractional Microneedling Radiofrequency Versus Fractional Carbon Dioxide Laser in Combination With Minoxidil for the Treatment of Androgenetic Alopecia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Patient satisfaction
研究概览
简要总结
Patients with Androgenetic alopecia will be randomized into 2 groups; Group FCO2 receiving Fractional CO2 or Group FRF receiving Fractional Microneedling Radiofrequency.
详细描述
Group FCO2 will be to receiving fractional CO2 to one randomized side of the scalp, and Group FRF will be receiving Fractional Microneedling radiofrequency to one randomized side of the scalp.
All patients will receive 4 sessions with 4-week intervals.each session will be followed by immediate topical application of 6 puffs (=1 mL) of minoxidil 5% solution twice daily and also in between the sessions and during follow up period
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, Outcomes Assessor)
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
- •• both genders are included.
- •Patients above 18 years old.
排除标准
- •• Patients with patchy hair loss.
- •Patients with Telogen Effluvium or diffuse alopecia areata.
- •Patients with cicatricial alopecias.
- •Patients with associated inflammatory scalp disorders such as psoriasis or seborrheic dermatitis.
- •Patients with collagen vascular disorders.
- •Prior use of topical steroids on scalp in the previous 2 weeks.
- •Prior use of systemic steroids in the previous 1 month.
结局指标
主要结局
Patient satisfaction
时间窗: 6months-1 year
Participants will be also asked to give their assessment on a scale of 4, (0) no satisfaction (1) slight satisfation, (2) moderate satisfaction, (3) marked satisfaction. A higher numerical means a better outcome.
Phototrichogram assessment.
时间窗: 2 months
A phototrichogram system (Dino-Lite; AnMo Electronics, Taiwan)will be used to evaluate the thickness of hairs. A higher numerical means a better outcome.
Clinical Global improvement Assessment
时间窗: 6months-1 year
Photographs will be taken with a Canon camera under controlled light in approximately the same position, taken at baseline, after 4 treatment sessions (16 weeks post treatment) and 2 months after follow-up (24 weeks post treatment). First clinical assessment will be performed based on the clinical change from baseline at 16 weeks post treatment. Change in the clinical will be measured on a 6 point scale; (-1) worsening, (0) no improvement, (1) less than 25% improvement, (2) 25-50% improvement, (3) 50-75% improvement, (4) more than 75% improvement. A higher numerical means a better outcome.
次要结局
未报告次要终点
研究者
Rana F Hilal, MD
Assistant Professor
Kasr El Aini Hospital