Topical Garlic Concentrate for Alopecia Areata in Children: A Prospective Open Label Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Percentage change of SALT scores at 6 months compared to baseline.
研究概览
简要总结
Management of pediatric alopecia is particularly challenging given the chronicity of the condition, limited therapeutic response and devastating psychological effects. There is a paucity of safe and effective therapies in this population.
The investigators propose to conduct and open label, prospective cohort pilot study using topical garlic concentrate ( GarlicRich) for treatment of children with alopecia areata. Study medication will be applied topically on affected area of the skin daily for 6 months. Follow up visits will occur monthly to access the efficacy and safety of the proposed treatment .
详细描述
The investigators are planning to enroll in the study 20 participants at Sickkids.
It is an open label, prospective cohort pilot study. Patients enrolled in the study will be followed at the Hospital for Sick Children for 6 months. Participants will come for the study visits every month (7 study visits). During each study visit two investigators will independently access patient's hair density and calculate the SALT score (Severity of Alopecia Tool Score), using the participant's digital photographs.
Patients will be provided with the study medication for all duration of the study.
The results of the treatment will be compared with the baseline data ( pictures/ scores/ hair density) to evaluate the efficacy and safety of garlic concentrate in children with patchy alopecia areata.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4 years and older up to 18 years of age
- •Patches of alopecia areata that affect less than 50% of the scalp.
- •Alopecia of at least 1 year duration without evidence of regrowth
- •Informed written consent
排除标准
- •Any children experiencing significant spontaneous regrowth of terminal hair at the baseline visit.
- •Any children treated with a topical, (including shampoos with active ingredients like minoxidil or clobetasol), intralesional or systemic agent likely to cause regrowth in alopecia areata within the past month from the baseline visit and during study period.
- •Children with history of hypersensitivity to garlic.
- •Children with widespread alopecia areata as alopecia totalis, universalis, ophiasis or diffuse Alopecia Areata.
研究组 & 干预措施
Garlic concentrate
Garlic gel concentrate- once a day topical application
干预措施: garlic concentrate (Drug)
结局指标
主要结局
Percentage change of SALT scores at 6 months compared to baseline.
时间窗: 6 months
Percentage change of SALT scores at 6 months compared to baseline
次要结局
- Type of hair regrowth at 6 months(6 months)
- Parental/patient assessment of hair regrowth using a 100 mm visual analog scale with 3 anchors (total loss, no change, full regrowth) where 5 mm corresponds to 10% change(6 months)
- Correlation between SALT scores and parental/patient assessment of regrowth at 6 months.(6 months)
- Categorical percent hair regrowth(6 months)
- Proportion of subjects with at least 70% hair regrowth using the percent scalp hair regrowth based on SALT score.(6 months)
- Density of hair regrowth at 6 months(6 months)
- Intra-class correlations between the two investigators' assessments using SALT and VAS assessment of hair regrowth(1,2,3,4,5,6 months)
- Correlation between surface area and SALT score(1,2,3,4,5,6 months)
- Percentage of patients experiencing adverse effects (erythema, irritation, contact dermatitis), collected by investigator and reported by the parents in the study diaries.(0-6 months)
研究者
Elena Pope
Professor of Paediatrics, University of Toronto Fellowship Director and Section Head, Paediatric Dermatology
The Hospital for Sick Children