Comparison of Efficacy of Microneedling Along With Topical Vitamin D3 Versus Microneedling Alone in the Treatment of Alopecia Areata
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Proportion of patients achieving complete hair regrowth (S0 on SALT score)
研究概览
简要总结
Alopecia areata is a common condition that causes sudden, patchy hair loss on the scalp and other body sites. It is believed to occur when the body's immune system mistakenly attacks the hair follicles, leading to hair loss that can range from small patches to more widespread involvement. While many treatments have been tried, including steroids and newer medicines, none offer a guaranteed permanent cure.
Microneedling is a technique in which very fine needles are used to create small punctures in the skin. This stimulates natural healing, improves blood supply to hair roots, and activates stem cells that support new hair growth. It also allows medicines applied to the skin to penetrate more effectively. Previous studies have shown that combining microneedling with certain topical medicines improves results compared to microneedling alone.
Vitamin D is known to play an important role in the regulation of the immune system and in the health of hair follicles. Applying vitamin D directly to the scalp after microneedling may enhance its effects, as the microchannels created by the needles allow the medicine to reach the deeper layers of the skin.
This study will compare two treatment approaches for patients with localized alopecia areata (affecting less than half of the scalp). One group will receive microneedling alone, while the other group will receive microneedling combined with topical vitamin D3. The treatments will be given every two weeks for a total of six sessions. Patients will then be followed for three months to see whether they achieve complete regrowth of hair in the affected areas, as measured by a standard scoring system for alopecia areata (SALT score).
The study will enroll 80 adults aged 18-60 years who have alopecia areata and have not received any recent treatment. By comparing these two approaches, the study aims to find out whether adding topical vitamin D3 to microneedling improves treatment outcomes. If effective, this combination could provide patients with a safe, affordable, and non-invasive option for treating alopecia areata.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Alopecia Areata and have not received any treatment for last 4 weeks.
- •Age range of 18-60 years
- •Both male and female patients
排除标准
- •Active infection or atrophy of scalp due to previous treatment
- •Patients with alopecia universalis or totalis.
- •Pregnant or lactating mothers.
- •Systemic co-morbidities like diabetes, hypertension, chronic liver or kidney disease and immunosuppression
- •Unwilling or uncooperative patients
结局指标
主要结局
Proportion of patients achieving complete hair regrowth (S0 on SALT score)
时间窗: 3 months after initiation of treatment (following up to 6 treatment sessions given at 2-week intervals).
The Severity of Alopecia Tool (SALT) score will be used to measure the extent of scalp hair loss. The scale ranges from S0 (no hair loss, complete regrowth) to S5 (100% hair loss). Treatment will be considered effective if participants achieve S0 (complete hair regrowth with no hair loss) at the end of the study period compared with baseline assessment. Clinical photographs and dermoscopic findings will also be used to validate outcomes.
次要结局
- Dermoscopic improvement in alopecia areata lesions.(From baseline to 3 months after treatment initiation)
研究者
Rameen Masood
Principal Investigator
Services Institute of Medical Sciences, Pakistan