Topical Garlic Concentrate for Alopecia Areata in Children

Study Overview
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Brief Summary
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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 .

Detailed Description
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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.

Official Title
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Topical Garlic Concentrate for Alopecia Areata in Children: A Prospective Open Label Study

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: garlic concentrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Garlic concentrate<br>Garlic gel concentrate- once a day topical application | Drug: garlic concentrate<br>* Topical application of GarlicRich gel on the scalp areas affected with alopecia areata once a day for 6 months<br>* Other names: GarlicRich;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change of SALT scores at 6 months compared to baseline. | Percentage change of SALT scores at 6 months compared to baseline | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Categorical percent hair regrowth | SALT derived percent regrowth, categorized as: A0 = no change or further loss; A1= 1-24% regrowth; A2= 25-49% regrowth; A3= 50-74% regrowth; A4= 75-99% regrowth; A5= 100% regrowth | 6 months | 
| Proportion of subjects with at least 70% hair regrowth using the percent scalp hair regrowth based on SALT score. | 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 | Density will be measured by using a dermatoscope and calculating the number of hairs in the field | 6 months | 
| Type of hair regrowth at 6 months | Type of hair will be a categorical variable with 3 types of values: vellus, indeterminate and terminal hairs | 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 | VOS will be used by parents/ patient only once at the final study visit to access the result of the study treatment. | 6 months | 
| Intra-class correlations between the two investigators' assessments using SALT and VAS assessment of hair regrowth | The results of two study investigator's assessment (SALT and VAS) will be compared at each study visit. | 1,2,3,4,5,6 months | 
| Correlation between surface area and SALT score | Correlation between surface area and SALT score | 1,2,3,4,5,6 months | 
| Correlation between SALT scores and parental/patient assessment of regrowth at 6 months. | Correlation between SALT scores and parental/patient assessment of regrowth | 6 months | 
| Percentage of patients experiencing adverse effects (erythema, irritation, contact dermatitis), collected by investigator and reported by the parents in the study diaries. | Percentage of patients experiencing adverse effects | 0-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alopecia Areata, Garlic concentrate