Microneedling-Assisted Delivery of Cetirizine Versus Latanoprost in Alopecia Areata: A Pilot Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Severity of Alopecia Tool Score (SALT Score)
研究概览
简要总结
This study planned to measure the effectiveness and safety of microneedling aided administration of cetirizine 1% versus latanoprost 0.01% in alopecia areata.
详细描述
Alopecia areata (AA) is a chronic inflammatory disease affecting the hair follicles with a possible multifactorial origin, most prominently in genetically predisposed patients. It is a common cause of non scarring hair loss that presents in a patchy, confluent, or diffuse pattern. The onset may be at any age and there is no known race or sex preponderance.
The treatment of AA depends on the severity and extent of the disease. Treatment options include topical or intralesional corticosteroids, phototherapy, topical irritants, topical minoxidil, topical tacrolimus, topical vitamin D analogs and platelet rich plasma injection. For resistant cases, psoralen with ultraviolet A light, oral cyclosporine and other immunosuppressants could be beneficial.
Microneedling therapy is becoming popular in management of acne scars and also for facial rejuvenations. Recently it has been shown to stimulate hair growth. The proposed mechanism of action is thought to be stimulation of dermal papilla and stem cells and also increasing the blood supply to the hair follicles.
Scalp microneedling is a minimally invasive procedure in which various micro-channels are created by short fine needles to help in penetration and absorption of various agents into the skin. So, microneedling is a promising and effective therapy for the treatment of AA
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newly diagnosed cases of alopecia areata.
- •Patients of any age.
- •Both male and female patients.
- •Recent-onset patchy alopecia areata of ≤6 months' duration.
- •Presence of no more than two alopecia patches.
- •Stationary course of the disease.
- •Willingness to participate in the study.
- •Provision of written informed consent or parental/guardian consent for minors.
排除标准
- •Extensive alopecia areata, including alopecia totalis or alopecia universalis.
- •Previous treatment of the alopecia areata lesions.
- •Active scalp infection.
- •Presence of associated dermatological, systemic, or autoimmune comorbidities.
- •Known allergy or hypersensitivity to any of the planned therapeutic agents.
研究组 & 干预措施
Group B
Patients treated with microneedling-aided administration of topical latanoprost 0.01% solution.
干预措施: Latanoprost (Drug)
Group A
Patients treated with microneedling-aided administration of topical cetirizine 1% solution.
干预措施: Cetirizine (Zyrtec) (Drug)
Group D
Patients treated with microneedling only as a negative control group
干预措施: Microneedling only (Procedure)
group C
Patients treated with microneedling-aided administration of topical triamcinolone acetonide (TrA) (10mg/ml) as a positive control group
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
Severity of Alopecia Tool Score (SALT Score)
时间窗: Baseline and 12 weeks
The Severity of Alopecia Tool (SALT) score was used to assess the extent of scalp hair loss. The score ranges from 0 to 100, with higher scores indicating greater scalp hair loss. Changes in SALT score from baseline was compared between the treatment groups.
次要结局
- Global assessment of hair regrowth(Baseline and at the end of the 12-week treatment period)
- Adverse events(Throughout the 12-week study period.)
研究者
Yomna Mazid El-Hamd Neinaa
Assistant Professor of Dermatology and Venereology
Tanta University