Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-65
SponsorRestore Biologics Holdings, Inc. dba Xtressé
About this trial
The goal of this study is to determine if Xtresse' gummy is safe and may help regrow hair in men with androgenic alopecia (common pattern hair loss). Forty-eight participants will be randomly assigned to receive either Xtresse' active gummy or placebo. Neither staff not participant will know which treatment is given.
The main aims of this trial are:
1. To confirm using photographic analysis, changes in the quality, volume, and thickness of hair. 2. To gauge patient satisfaction with hair changes and application process. 3. Monitor and report any adverse events associated with the daily intake of Xtressé
Participants who qualify will complete 3 in-person visits. Participants will be given a 90-day supply of the gummies at visits 1 (after voluntary consent is given) and 2 to cover the 6-month study period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males aged 18-65
Norwood III to IV, vertex focused
Fitzpatrick skin type I to VI
Ability and willingness to comply with study protocol
Disqualifiers
Change in other hair treatments in 3 months prior to study enrollment.
Known uncontrolled health conditions.
History of hair or scalp disorders that could interfere with study results.
History of metabolic syndrome.
Trial design
Design model
Parallel
Treatments tested in this trial
Xtressé Hair Growth Gummies
Other interventionThe nutraceutical supplement is powered by proprietary X-3 BioActive Blend and contains plant based extracts and regenerative compounds not commonly found in existing hair supplements. The dosage is 2 gummies taken once per day.
Placebo Comparator
Dietary supplementThe placebo supplement will contain no active ingredients. Participants will receive 3 month supply 2 times during the study. Participants will take 2 supplements daily.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Xtressé Nutraceutical Supplement ActiveExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis
Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 6 months of taking Xtressé™ Supplements. Measurements of density as measured hair per cm².
Time frame
From enrollment to the end of treatment at 6 months2
Within-subject increase in hair thickness assessed via Canfield HairMetrix® Phototrichogram Analysis
Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 6 months of taking Xtressé™ Supplements. Measurements of follicular unit vellus/terminal ratio.
Time frame
From enrollment to the end of treatment at 6 months3
Hair Density Changes measured by SOCAi
Images will be captured using the the SOCAi system at baseline and Days 90, and 180, to evaluate hair density changes.
Time frame
From enrollment to the end of treatment at 6 monthsSecondary outcomes
1
Incidence of Adverse Events associated with Treatment
Collect and quantify the incidence of treatment-related adverse events and treatment-related serious adverse events associated with the daily intake of supplement
Time frame
From first treatment until the end of treatment at 6 monthsOther outcomes
1
Participant self-assessment of hair improvements collected via questionnaire
Observations and changes in hair loss graded on scale of 0 to 4 with 0 as no change and 4 as a very severe outcome. Observations are based on self-assessments completed at baseline and Day 180.
Time frame
From enrollment to the end of study at 6 monthsSponsors 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: