Topical Garlic Concentrate for Alopecia Areata in Children

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02691117
• Other study ID #: 1000050555
• Status: Terminated
• Phase: Phase 3
• First received: December 15, 2015
• Last updated: April 17, 2018
• Start date: January 10, 2016
• Est. completion date: December 1, 2017

Study information

• Verified date: April 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 1, 2017
• Est. primary completion date: August 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• garlic concentrate
Topical application of GarlicRich gel on the scalp areas affected with alopecia areata once a day for 6 months

Locations

Country	Name	City	State
Canada	Th Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Elena Pope	Dermatology Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Correlation between surface area and SALT score	Correlation between surface area and SALT score	1,2,3,4,5,6 months
Secondary	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
Secondary	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