For an Investigator-led Hair Study Comparing Between Healthy and Hair Loss Volunteers
ConditionHair Loss
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age21-45
SponsorNational Skin Centre
About this trial
This study is to evaluate differences in the gut and follicle/scalp microbiome signature in AGA compared to a non-AGA population. Also, to investigate differences in inflammation and other biomarkers in AGA compared to non-AGA population at baseline and after a successful treatment
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male volunteer from 21 to 45 years old
Volunteer with BMI between 18.5 to 30 kg/m2
Volunteer willing and able to fulfill the study requirements and schedule
Volunteer willing to give their stool sample, as well as swabs, follicles, and blood.
Disqualifiers
Volunteer with severe gastro-intestinal symptoms (including gluten and lactose intolerance)
Volunteer with auto-immune disease, diabetes; hyper or hypo-thyroidism ; chronic kidney failure
Volunteer with diagnosis of scalp-related disease such as folliculitis, lichen planopilaris, folliculitis decalvans, tinea capitis, head lice, or seborrheic dermatitis
Volunteer undergoing hypertension treatment
Trial population
AGA volunteers will be referred by clinicians from National Skin Centre Healthy volunteers will be recruited by recruitment posters at National Skin Centre
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
66 Participants
are grouped into 2 trial groupsGroup A: Healthy
Group B: AGA patients
Trial outcomes
Primary outcomes
1
Norwoord-Hamiton scale hairloss severity
Scale from 1 (no hair loss) to 7 (severe hair loss)
Time frame
6 months2
Change in hair density
Change from baseline in hair density at the vertex, crown and occipital zones Unit: u/cm2
Time frame
6 months3
Metabolomic profiling of the stool
Change in concentration of metabolites in the stool of AGA vs healthy cohorts.
Time frame
6 months4
Gut and Scalp/Follicle Microbiome Signature Differences at Baseline
Taxonomic and functional composition of the gut and scalp/hair follicle microbiome. Units: relative abundance
Time frame
BaselineSecondary outcomes
1
Eyebrow to hairline measurement
The distance from the eyebrow to the hairline is one indicator of the recession of hairline
Time frame
6 months2
Dandruff scoring
The dandruff score ranges from 0 (no dandruff state) to 5 (very important dandruff state) for both adherent and non-adherent dandruffs
Time frame
6 months3
Change in Subject-Reported Hair Density
Evaluation of the volunteer's perceived change in hair density since the start of the study (assessed via self-assessment questionnaire). Scale : improvements range from "worsened significantly" to "improved significantly"
Time frame
6 months4
Measurement of sebum levels
Measure sebum levels on the forehead and scalp
Time frame
6 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: