Clinical trial NCT02691117: Topical Garlic Concentrate for Alopecia Areata in Children
Official title: Topical Garlic Concentrate for Alopecia Areata in Children: A Prospective Open Label Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alopecia Areata
Keywords: Alopecia Areata
Garlic concentrate
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Dermatology Foundation
First posted: 2016-02-25
Enrollment: 8
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage change of SALT scores at 6 months compared to baseline.
timeFrame: 6 months
Secondary outcomes:
measure: Categorical percent hair regrowth
timeFrame: 6 months
measure: Proportion of subjects with at least 70% hair regrowth using the percent scalp hair regrowth based on SALT score.
timeFrame: 6 months
measure: Density of hair regrowth at 6 months
timeFrame: 6 months
measure: Type of hair regrowth at 6 months
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: Intra-class correlations between the two investigators' assessments using SALT and VAS assessment of hair regrowth
timeFrame: 1,2,3,4,5,6 months
measure: Correlation between surface area and SALT score
timeFrame: 1,2,3,4,5,6 months
measure: Correlation between SALT scores and parental/patient assessment of regrowth at 6 months.
timeFrame: 6 months
measure: Percentage of patients experiencing adverse effects (erythema, irritation, contact dermatitis), collected by investigator and reported by the parents in the study diaries.
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Th Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Elena Pope, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: