Topical Garlic Concentrate for Alopecia Areata in Children
Keywords
Abstract
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.
Dates
| Last Verified: | 03/31/2018 |
| First Submitted: | 12/14/2015 |
| Estimated Enrollment Submitted: | 02/18/2016 |
| First Posted: | 02/24/2016 |
| Last Update Submitted: | 04/16/2018 |
| Last Update Posted: | 04/18/2018 |
| Actual Study Start Date: | 01/09/2016 |
| Estimated Primary Completion Date: | 08/14/2017 |
| Estimated Study Completion Date: | 11/30/2017 |
Condition or disease
Intervention/treatment
Drug: Garlic concentrate
Phase
Arm Groups
| 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 |
Eligibility Criteria
| Ages Eligible for Study | 4 Years To 4 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
Primary Outcome Measures
1. Percentage change of SALT scores at 6 months compared to baseline. [6 months]
Secondary Outcome Measures
1. Categorical percent hair regrowth [6 months]
2. Proportion of subjects with at least 70% hair regrowth using the percent scalp hair regrowth based on SALT score. [6 months]
3. Density of hair regrowth at 6 months [6 months]
4. Type of hair regrowth at 6 months [6 months]
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 [6 months]
6. Intra-class correlations between the two investigators' assessments using SALT and VAS assessment of hair regrowth [1,2,3,4,5,6 months]
7. Correlation between surface area and SALT score [1,2,3,4,5,6 months]
8. Correlation between SALT scores and parental/patient assessment of regrowth at 6 months. [6 months]
9. Percentage of patients experiencing adverse effects (erythema, irritation, contact dermatitis), collected by investigator and reported by the parents in the study diaries. [0-6 months]
