Alopecia AreataPhase 3NCT02691117
Topical Garlic Concentrate for Alopecia Areata in Children
A Phase 3 study testing garlic concentrate in people with Alopecia Areata, run by Elena Pope at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- garlic concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2016to 1 Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Garlic Concentrate for Alopecia Areata in Children: A Prospective Open Label Study
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 .
Read the 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.
- Conditions
- Alopecia Areata
- Being tested
- garlic concentrate
- Keywords
- Alopecia Areata, Garlic concentrate
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
garlic concentrateDrug
Also called GarlicRich
Topical application of GarlicRich gel on the scalp areas affected with alopecia areata once a day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Garlic concentrate | Experimental | Garlic gel concentrate- once a day topical application Receives: Drug: garlic concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change of SALT scores at 6 months compared to baseline.
Percentage change of SALT scores at 6 months compared to baseline
Measured: 6 months
Secondary outcomes (9)
Categorical percent hair regrowth
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
Measured: 6 months
Proportion of subjects with at least 70% hair regrowth using the percent scalp hair regrowth based on SALT score.
Proportion of subjects with at least 70% hair regrowth using the percent scalp hair regrowth based on SALT score.
Measured: 6 months
Density of hair regrowth at 6 months
Density will be measured by using a dermatoscope and calculating the number of hairs in the field
Measured: 6 months
Type of hair regrowth at 6 months
Type of hair will be a categorical variable with 3 types of values: vellus, indeterminate and terminal hairs
Measured: 6 months
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
VOS will be used by parents/ patient only once at the final study visit to access the result of the study treatment.
Measured: 6 months
Intra-class correlations between the two investigators' assessments using SALT and VAS assessment of hair regrowth
The results of two study investigator's assessment (SALT and VAS) will be compared at each study visit.
Measured: 1,2,3,4,5,6 months
Correlation between surface area and SALT score
Correlation between surface area and SALT score
Measured: 1,2,3,4,5,6 months
Correlation between SALT scores and parental/patient assessment of regrowth at 6 months.
Correlation between SALT scores and parental/patient assessment of regrowth
Measured: 6 months
Percentage of patients experiencing adverse effects (erythema, irritation, contact dermatitis), collected by investigator and reported by the parents in the study diaries.
Percentage of patients experiencing adverse effects
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study start10 Jan 2016
- Primary completion15 Aug 2017
- Study completion1 Dec 2017
Why it stopped: Lack of efficacy of the study medication
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elena Pope
- Sponsor type
- University, hospital or other
- Collaborators
- Dermatology Foundation
- Responsible party
- Sponsor-investigator, Elena Pope, The Hospital for Sick Children
- Investigators
- Elena Pope, MD, MSc, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691117
- Sponsor's protocol ID
- 1000050555
- Status last verified
- Apr 2018
- First submitted
- 15 Dec 2015
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: only aggregated data will be available to participants
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Garlic Concentrate for Alopecia Areata in Children: A Prospective Open Label Study
- ClinicalTrials.gov ID
- NCT02691117
- Acronym / sponsor ID
- 1000050555
- Conditions
- Alopecia Areata
- Keywords
- Alopecia Areata, Garlic concentrate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy of the study medication
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Elena PopeUniversity, hospital or other
- Collaborators
- Dermatology Foundation
- Study start
- 10 Jan 2016 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Garlic concentrate | Experimental | Drug: garlic concentrateGarlic gel concentrate- once a day topical application |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| garlic concentrateAlso: GarlicRichTopical application of GarlicRich gel on the scalp areas affected with alopecia areata once a day for 6 months | Drug | Garlic concentrate |
Primary outcome
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
9 secondary outcomes
Categorical percent hair regrowth
Time frame: 6 months
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
Type of hair regrowth at 6 months
Time frame: 6 months
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
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
Results and safety
The study was stopped early (reason given: Lack of efficacy of the study medication). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Individual participant dataSharing planned: No. only aggregated data will be available to participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Pope, MD, MSc principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing garlic concentrate in people with Alopecia Areata, run by Elena Pope at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of efficacy of the study medication). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change of SALT scores at 6 months compared to baseline. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.