Topical Garlic Concentrate for Alopecia Areata in Children

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

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 .

Study Overview

• Status: Terminated
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: garlic concentrate

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X8
      • Th Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Elena Pope
• Collaborators: Dermatology Foundation
• Investigators: Principal Investigator: Elena Pope, MD, Msc, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2016
• Primary Completion (Actual): August 15, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: February 19, 2016
• First Posted (Estimate): February 25, 2016

Study Record Updates

• Last Update Posted (Actual): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Alopecia Areata; Garlic concentrate
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: 1000050555

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: only aggregated data will be available to participants