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Topical Garlic Concentrate for Alopecia Areata in Children

Primary Purpose

Alopecia Areata

Status

Terminated

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

garlic concentrate

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia Areata, Garlic concentrate

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Th Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Garlic concentrate

Arm Description

Garlic gel concentrate- once a day topical application

Outcomes

Primary Outcome Measures

Percentage change of SALT scores at 6 months compared to baseline.

Percentage change of SALT scores at 6 months compared to baseline

Secondary Outcome Measures

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

Proportion of subjects with at least 70% hair regrowth using the percent scalp hair regrowth based on SALT score.

Density of hair regrowth at 6 months

Density will be measured by using a dermatoscope and calculating the number of hairs in the field

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

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.

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.

Correlation between surface area and SALT score

Correlation between SALT scores and parental/patient assessment of regrowth at 6 months.

Correlation between SALT scores and parental/patient assessment of regrowth

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

Full Information

NCT ID

NCT02691117

First Posted

December 15, 2015

Last Updated

April 17, 2018

Sponsor

Elena Pope

Collaborators

Dermatology Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02691117

Brief Title

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

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Terminated

Why Stopped

Lack of efficacy of the study medication

Study Start Date

January 10, 2016 (Actual)

Primary Completion Date

August 15, 2017 (Actual)

Study Completion Date

December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Elena Pope

Collaborators

Dermatology Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alopecia Areata

Keywords

Alopecia Areata, Garlic concentrate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Garlic concentrate

Arm Type

Experimental

Arm Description

Garlic gel concentrate- once a day topical application

Intervention Type

Drug

Intervention Name(s)

garlic concentrate

Other Intervention Name(s)

GarlicRich

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage change of SALT scores at 6 months compared to baseline.

Description

Percentage change of SALT scores at 6 months compared to baseline

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Categorical percent hair regrowth

Description

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

Time Frame

6 months

Title

Proportion of subjects with at least 70% hair regrowth using the percent scalp hair regrowth based on SALT score.

Description

Proportion of subjects with at least 70% hair regrowth using the percent scalp hair regrowth based on SALT score.

Time Frame

6 months

Title

Density of hair regrowth at 6 months

Description

Density will be measured by using a dermatoscope and calculating the number of hairs in the field

Time Frame

6 months

Title

Type of hair regrowth at 6 months

Description

Type of hair will be a categorical variable with 3 types of values: vellus, indeterminate and terminal hairs

Time Frame

6 months

Title

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

Description

VOS will be used by parents/ patient only once at the final study visit to access the result of the study treatment.

Time Frame

6 months

Title

Intra-class correlations between the two investigators' assessments using SALT and VAS assessment of hair regrowth

Description

The results of two study investigator's assessment (SALT and VAS) will be compared at each study visit.

Time Frame

1,2,3,4,5,6 months

Title

Correlation between surface area and SALT score

Description

Correlation between surface area and SALT score

Time Frame

1,2,3,4,5,6 months

Title

Correlation between SALT scores and parental/patient assessment of regrowth at 6 months.

Description

Correlation between SALT scores and parental/patient assessment of regrowth

Time Frame

6 months

Title

Percentage of patients experiencing adverse effects (erythema, irritation, contact dermatitis), collected by investigator and reported by the parents in the study diaries.

Description

Percentage of patients experiencing adverse effects

Time Frame

0-6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elena Pope, MD, MSc

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

Facility Information:

Facility Name

Th Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G1X8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

only aggregated data will be available to participants

Learn more about this trial

Topical Garlic Concentrate for Alopecia Areata in Children

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