Topical Garlic Concentrate for Alopecia Areata in Children

NCT02691117 | Terminated Phase 3

• 1 other identifier: 1000050555
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 .

Conditions

Alopecia Areata

Keywords

Alopecia Areata; Garlic concentrate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Categorical percent hair regrowth

  6 months

• 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

  6 months

• Type of hair regrowth at 6 months

  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

  6 months

Study Arms (1)

Garlic concentrate

EXPERIMENTAL

Garlic gel concentrate- once a day topical application

Drug: garlic concentrate

Interventions

garlic concentrate DRUG

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

Also known as: GarlicRich

Garlic concentrate

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elena Pope: lead
• Dermatology Foundation: collaborator

Study Sites (1)

Th Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elena Pope, MD, MSc

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Paediatrics, University of Toronto Fellowship Director and Section Head, Paediatric Dermatology

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: February 25, 2016
• Study Start: January 10, 2016
• Primary Completion: August 15, 2017
• Study Completion: December 1, 2017
• Last Updated: April 19, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)