Topical Garlic Concentrate for Alopecia Areata in Children

NCT ID: NCT02691117

Last Updated: 2018-04-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-10
• Study Completion Date: 2017-12-01

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.

Conditions

Alopecia Areata

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Garlic concentrate

Garlic gel concentrate- once a day topical application

Group Type: EXPERIMENTAL

garlic concentrate

Intervention Type: DRUG

Topical application of GarlicRich gel on the scalp areas affected with alopecia areata once a day for 6 months

Interventions

garlic concentrate

Topical application of GarlicRich gel on the scalp areas affected with alopecia areata once a day for 6 months

Intervention Type: DRUG

Other Intervention Names

GarlicRich

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dermatology Foundation

OTHER

Sponsor Role: collaborator

Elena Pope

OTHER

Sponsor Role: lead

Responsible Party

Elena Pope

Professor of Paediatrics, University of Toronto Fellowship Director and Section Head, Paediatric Dermatology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Elena Pope, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

Th Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000050555

Identifier Type: -

Identifier Source: org_study_id