Topical Garlic Concentrate for Alopecia Areata in Children

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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

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Categorical percent hair regrowth

Condition

Alopecia Areata

Intervention

garlic concentrate

Study Arms / Comparison Groups

 Garlic concentrate
Description:  Garlic gel concentrate- once a day topical application

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

8

Start Date

January 10, 2016

Completion Date

December 1, 2017

Primary Completion Date

August 15, 2017

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.
      

Gender

All

Ages

4 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Elena Pope, MD, MSc, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02691117

Organization ID

1000050555


Responsible Party

Sponsor-Investigator

Study Sponsor

Elena Pope

Collaborators

 Dermatology Foundation

Study Sponsor

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


Verification Date

April 2018