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 .
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Topical application of GarlicRich gel on the scalp areas affected with alopecia areata once a day for 6 months
Th Hospital for Sick Children
Toronto, Ontario, Canada
Percentage change of SALT scores at 6 months compared to baseline.
Percentage change of SALT scores at 6 months compared to baseline
Time frame: 6 months
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 6 months
Intra-class correlations between the two investigators' assessments using SALT and VAS assessment of hair regrowth
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The results of two study investigator's assessment (SALT and VAS) will be compared at each study visit.
Time frame: 1,2,3,4,5,6 months
Correlation between surface area and SALT score
Correlation between surface area and SALT score
Time frame: 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
Time frame: 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
Time frame: 0-6 months