Assessment of Efficacy and Safety of Sodium Valproate -Loaded Nanospanlastics in Patients With Patchy Alopecia Areata in Comparison to Conventional Therapy With Topical Steroids: a Randomized Controlled Study, With Clinical, Dermoscopic and Molecular Asessements
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- - Treatment success
研究概览
简要总结
the aim of this study is to assess the efficacy and safety of sodium valproate-loaded nanospanlastic in the treatment of patchy AA, in comparison to conventional therapy with topical steroids
详细描述
Alpopecia Areata (AA) is the second common cause of non-scarring hair loss, the disease has huge negative impact on patients' quality of life, social and psychological status. The underlying pathogenesis of AA is not fully characterized, Yet the collapse of immune privilege and generation of autoimmune attack against unknown follicular antigens are the most agreed-upon theories behind the disease. In spite of various therapeutic armamentariums available for AA, no single agent has been proven efficacious regarding reversing hair loss and establishing long-term response.
keeping in mind the burden of the disease together with lacking effective treatments, a need for further therapies is colossal.
Wnt-b catenin pathway is one of the crucial signalling pathways that regulate hair cycling. An increasing body of evidence is supporting the fact that wnt-b catenin pathway is inhibited in AA, and therefore contributing to the hair loss that characteize the disease.
Sodium valproate (SV), a well-known anti-epileptic drug, was found to inhibit Glycogen synthase kinase-3beta (GSK3β) in neuronal cells as one of the possible antiepileptic mechanisms of SV. GSK3B is a well-known inhibitor of β-catenin activity in dermal papilla cells (DPCs), and thus induces catagen-like changes in these cells. So the idea of using topical SV to promote hair regrowth via activation of b catenin came up and attracted the interests of investigators. recently an optimized sodium valproate-loaded nanospanlastics topical formula promisingly achieved clinical equivalence with 5% minoxidil lotion in AGA, with a superior safety profile to minoxidil
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderate patchy alopecia areata, which is defined as less than 50% involvement of the entire scalp
- •Age above 12 years.
- •Both genders.
- •Patients with patchy alopecia areata, with 2 patches or more
排除标准
- •Patients having single patch alopecia areata (at least 2 patches are required, as one patch will be left untreated to exclude the possibility of spontaneous remission)
- •Affection of more than 50% of the scalp area
- •Patients with alopecia totalis or universalis
- •Patients with ophiasis
- •Age: Less than 12 years old.
- •Pregnant or lactating females
- •Patients with history of or existing scalp skin diseases, infections or skin cancer
- •Severe systemic illness (as uncontrolled DM or hypertension, liver or renal diseases) and immune-compromised patients
- •Patients with concomitant autoimmune diseases as suspected by history or confirmed by previous investigations
- •Diagnosis or history of local dermatological disease in the scalp apart from AA such as eczema, seborrheic dermatitis, psoriasis.
- •Any psychiatric illness or psychological state impairing future compliance or influencing expectations of the patient
研究组 & 干预措施
sodium valproate group
Group 1 will be treated with the optimized sodium valproate-loaded nanospanlastic dispersion, twice daily on the affected areas of the scalp for 3 months
干预措施: the optimized sodium valproate-loaded nanospanlastic dispersion (Drug)
topical steroid group
Group 2 will be treated with the marketed mometasone furoate lotion twice daily on the affected areas of the scalp for 3 months
干预措施: mometasone furoate lotion (Drug)
结局指标
主要结局
- Treatment success
时间窗: 6 months
defined by achieving ≥ 50% reduction in baseline SALT score at end-of-study and/or achieving patient global assessment of improvement (PGAI) ≥ 50%.
次要结局
- molecular Assessment of treatment success rate of SV-loaded nanospanlastics in the treatment of mild to moderate patchy AA in comparison to conventional therapy with topical steroids(3 months)
- Patient global assessment of improvement(3 months)
- Patient satisfaction regarding characteristics of the used topical treatment(3 months)
- Dermoscopic evaluation of hair regrowth(3 months)
- Clinical satisfaction of each patient(3 months)
- Subjective assessment of any encountered adverse effects(3 months)
- Dermatology Life Quality Index (DLQI)(3 months)
- Assessment of relapse(6 months)
研究者
heba ahmed abdelgayed ibrahim
Dr
Kasr El Aini Hospital