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Topical Garlic Concentrate for Alopecia Areata in Children

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ClinicalTrials.gov Identifier: NCT02691117
Recruitment Status : Terminated (Lack of efficacy of the study medication)
First Posted : February 25, 2016
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
Dermatology Foundation
Information provided by (Responsible Party):
Elena Pope, The Hospital for Sick Children

Tracking Information
First Submitted Date  ICMJE December 15, 2015
First Posted Date  ICMJE February 25, 2016
Last Update Posted Date April 19, 2018
Actual Study Start Date  ICMJE January 10, 2016
Actual Primary Completion Date August 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
Percentage change of SALT scores at 6 months compared to baseline. [ Time Frame: 6 months ]
Percentage change of SALT scores at 6 months compared to baseline
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
Percentage change of SALT scores at 6 months compared to baseline. [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
  • 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 ]
    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 [ 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 ]
    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 [ Time Frame: 1,2,3,4,5,6 months ]
    Correlation between surface area and SALT score
  • Correlation between SALT scores and parental/patient assessment of regrowth at 6 months. [ Time Frame: 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. [ Time Frame: 0-6 months ]
    Percentage of patients experiencing adverse effects
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Garlic Concentrate for Alopecia Areata in Children
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alopecia Areata
Intervention  ICMJE Drug: garlic concentrate
Topical application of GarlicRich gel on the scalp areas affected with alopecia areata once a day for 6 months
Other Name: GarlicRich
Study Arms  ICMJE Experimental: Garlic concentrate
Garlic gel concentrate- once a day topical application
Intervention: Drug: garlic concentrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 17, 2018)
8
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2016)
20
Actual Study Completion Date  ICMJE December 1, 2017
Actual Primary Completion Date August 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02691117
Other Study ID Numbers  ICMJE 1000050555
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: only aggregated data will be available to participants
Responsible Party Elena Pope, The Hospital for Sick Children
Study Sponsor  ICMJE Elena Pope
Collaborators  ICMJE Dermatology Foundation
Investigators  ICMJE
Principal Investigator: Elena Pope, MD, MSc The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP