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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

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 .


Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: garlic concentrate Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical Garlic Concentrate for Alopecia Areata in Children: A Prospective Open Label Study
Actual Study Start Date : January 10, 2016
Actual Primary Completion Date : August 15, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Garlic concentrate
Garlic gel concentrate- once a day topical application
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. Correlation between surface area and SALT score [ Time Frame: 1,2,3,4,5,6 months ]
    Correlation between surface area and SALT score

  8. 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

  9. 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



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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691117


Locations
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Canada, Ontario
Th Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
Elena Pope
Dermatology Foundation
Investigators
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Principal Investigator: Elena Pope, MD, MSc The Hospital for Sick Children

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Responsible Party: Elena Pope, Professor of Paediatrics, University of Toronto Fellowship Director and Section Head, Paediatric Dermatology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02691117     History of Changes
Other Study ID Numbers: 1000050555
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: only aggregated data will be available to participants

Keywords provided by Elena Pope, The Hospital for Sick Children:
Alopecia Areata
Garlic concentrate

Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical