Androgenic Alopecia, Hair Loss/Baldness, Hair Thinning
Conditions
Brief summary
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.
Detailed description
In the study, participants will be asked to complete the following: Provide basic personal information (including date of birth, gender, race and ethnicity) Provide their medical/ surgical history and perform a medical exam (including but not limited to symptom-directed physical exam, skin type, vital signs, height, weight) Follow study rules such as avoiding certain medications and treatments Provide information on any medications, treatments or reactions that started after the study began Take active or placebo gummy treatment daily and complete a treatment diary Allow clinical assessments and documentation of the treatment, such as photography, hair density measurements, any reactions or side effects To qualify for this trial, participants must: Be a male adult between 18 to 65 years of age Have hair loss in vertex region. Give voluntary written consent Be willing to follow study instructions and complete study requirements, including maintaining current diet and hair care routine, not using non-approved lotions and creams on the treatments areas Allow photographs of the front and top area of the scalp Confirm they are not sensitive to any of the study treatment ingredients All photographs of the treatment area collected during the study will be used as study data. All participants have the right to refuse further participation in the study at any time.
Interventions
The 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.
DIETARY_SUPPLEMENTPlacebo Comparator
The placebo supplement will contain no active ingredients. Participants will receive 3 month supply 2 times during the study. Participants will take 2 supplements daily.
Sponsors
Restore Biologics Holdings, Inc. dba Xtressé
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Open label study evaluating safety and efficacy
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males aged 18-65 * Norwood III to IV, vertex focused * Fitzpatrick skin type I to VI * Ability and willingness to comply with study protocol
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis | From enrollment to the end of treatment at 6 months | 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. |
| Within-subject increase in hair thickness assessed via Canfield HairMetrix® Phototrichogram Analysis | From enrollment to the end of treatment at 6 months | 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. |
| Hair Density Changes measured by SOCAi | From enrollment to the end of treatment at 6 months | Images will be captured using the the SOCAi system at baseline and Days 90, and 180, to evaluate hair density changes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events associated with Treatment | From first treatment until the end of treatment at 6 months | Collect and quantify the incidence of treatment-related adverse events and treatment-related serious adverse events associated with the daily intake of supplement |
Countries
United States
Contacts
CONTACTDr. Matt Leavitt, DO
STUDY_DIRECTORMelissa Y Rayner, MS
Restore Biologics Holdings, Inc. dba Xtressé
Outcome results
None listed