Topical Garlic Concentrate for Alopecia Areata in Children | NCT02691117

Studies
Topical Garlic Concentrate for Alopecia Areata in Children

NCT02691117

Sponsor

Elena Pope

Status

Terminated

Last Update Posted

Apr 19, 2018Actual

Enrollment

8Actual

Phase

Phase 3

Conditions

Alopecia Areata

Interventions

garlic concentrate

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of efficacy of the study medication

Expanded Access Info

Start Date

Jan 10, 2016Actual

Primary Completion Date

Aug 15, 2017Actual

Completion Date

Dec 1, 2017Actual

First Submitted Date

Dec 15, 2015

First Submission Date that Met QC Criteria

Feb 19, 2016

First Posted Date

Feb 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2018

Last Update Posted Date

Apr 19, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elena Pope, Professor of Paediatrics, University of Toronto Fellowship Director and Section Head, Paediatric Dermatology, The Hospital for Sick ChildrenSponsor-Investigator

Lead Sponsor

Elena PopeOTHER

Collaborators

Name	Class
Dermatology Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Garlic concentrate	Experimental	Garlic gel concentrate- once a day topical application	Drug: garlic concentrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
garlic concentrate	Drug	Topical application of GarlicRich gel on the scalp areas affected with alopecia areata once a day for 6 months	Garlic concentrate

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elena Pope, MD, MSc	The Hospital for Sick Children	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Th Hospital for Sick Children		Toronto	Ontario	M5G1X8	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

only aggregated data will be available to participants

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000506	Alopecia Areata

Ancestor Terms

ID	Term
D000505	Alopecia
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided