Clinical Trial: Topical Garlic Concentrate for Alopecia Areata in Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Summary:

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.


Sponsor: Elena Pope

Current Primary Outcome: Percentage change of SALT scores at 6 months compared to baseline. [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Categorical percent hair regrowth [ Time Frame: 6 months ]
    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. [ Time Frame: 6 months ]
  • Density of hair regrowth at 6 months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
    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 [ Time Frame: 1,2,3,4,5,6 months ]
  • Correlation between surface area and SALT score [ Time Frame: 1,2,3,4,5,6 months ]
  • Correlation between SALT scores and parental/patient assessment of regrowth at 6 months. [ Time Frame: 6 months ]
  • Percentage of patients experiencing adverse effects (erythema, irritation, contact dermatitis), collected by investigator and reported by the parents in the study diaries. [ Time Frame: 0-6 months ]


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: December 15, 2015
Date Started: January 2016
Date Completion: December 2017
Last Updated: February 19, 2016
Last Verified: February 2016