Transepidermal Drug Delivery of Minoxidil Via Either Fractional Carbon Dioxide Laser or Microneedling Versus Its Topical Nanoparticles Preparation for Treatment of Alopecia Areata
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Regrowth scale
研究概览
简要总结
- Compare the clinical efficacy, and safety of transepidermal drug delivery of fractional CO2 laser versus microneedling followed by minoxidil 5% application for the treatment of alopecia areata.
- Evaluate the efficacy, and safety of minoxidil nanoparticles as a topical treatment of alopecia areata.
详细描述
Alopecia areata (AA) is the most common cause of non-scarring alopecia. (Hordinsky, 2013).
Although many patients improve spontaneously or respond to standard therapy, in patients with more severe and refractory disease, management can be quite challenging (Messenger et al., 2012 and Kranseler and Sidbury, 2017).
Corticosteroids either topical or intralesional are the most popular medications used to treat this condition. Other therapies such as topical minoxidil (MXD), anthralin, immunotherapy, systemic corticosteroids are also commonly used with variable success (Shumez et al., 2015).
Patients treated with MXD 5% have significant hair growth than placebo. Minoxidil was more effective for patchy alopecia than other types of AA such as ophiasis and alopecia totalis. It was ineffective in alopecia universalis (El-Taib et al., 2017).
In contrast, the incidence of adverse events associated with 10% MXD treatment was higher than with 5% MXD treatment. Therefore, new approaches are required to achieve both expected efficacy and safety (Oaku et al., 2022).
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
- None
入排标准
- 年龄范围
- 10 Years 至 50 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will include patients with alopecia areata
排除标准
- •Children below 18 years , pregnant and lactating women . patients with chronic hepatic, hematological disorders or immunocompromised patients.
- •patient recieved any treatment for alopecia areata in the last 3 months before the study.
- •patients with extensive types (alopecia totalis, universalis and surface area >50%).
研究组 & 干预措施
Group 1
six sessions of fractional carbon dioxide laser every 2 weeks will be done for 15 patients with alopecia areata followed immediately by topical application of minoxidil 5%
干预措施: Fractional CO2 laser (Device)
Group 2
six sessions of microneedling evry 2 weeks will be done for 15 patients with alopecia areata followed immediately by topical application of minoxidil 5%
干预措施: Derma pen (Device)
Group 3
15 patient of alopecia areata that will be treated by topical nanominoxidil for 3 months.
干预措施: Niosome minoxidil (Drug)
Group 4
15 patient of alopecia areata that will be treated by topical minoxidil 5% for 3 months
干预措施: Minoxidil Topical Spray (Drug)
结局指标
主要结局
Regrowth scale
时间窗: 6 months
0 score (regrowth \< 10%) no response score (regrowth 11-25%) poor response score (regrowth 26-50%) fair response score (regrowth 51-75%) satisfactory response score (regrowth ≥ 75%) excellent response
Mcdonald Hull and Norris Regrowth Scale (by trichoscope
时间窗: 6 months
Grade 1 - Regrowth of vellus hair. Grade 2 - Regrowth of sparse pigmented terminal hair. Grade 3 - Regrowth of terminal hair with patches of alopecia with patches of alopecia 50-75% in SALT score. Grade 4 - Regrowth of terminal hair on scalp with patches of alopecia \> 75% in SALT score.
次要结局
未报告次要终点
研究者
Ahmed Elsayed Mohamed
Assistant Lecturer
Assiut University
