The goal of this study is to determine how safe and effective it is to improve hair growth by applying a serum daily on the scalp of men and women with thinning hair. 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 usage of Xtressé serum. Participants who qualify will complete 4 visits after voluntary consent has been given. Participants will be given 4 bottles of serum to use during the study. The product will be applied daily over a 4-month period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth. Participants will complete a survey at the end of the study.
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, and pregnancy test) * Follow study rules such as avoiding certain medications and treatments * Provide information on any medications, treatments or reactions that started after the study began * Apply serum daily and complete a treatment log * 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 an adult between ages of 18-65 * Have consistent self-perceived thinning hair. * 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 treatment areas * Allow photographs of the front and top area of the scalp * Not be pregnant or breast feeding before and during the study and agree to use acceptable forms of birth control * 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The concentrate serum is powered by proprietary X-3 BioActive Blend and contains plant-based extracts and regenerative compounds not commonly found in existing hair supplements.
Advanced Dermatology & Cosmetic Surgery
Maitland, Florida, United States
Kindred Hair and Skin Center
Marriottsville, Maryland, United States
Root Hair Institute
Bellevue, Washington, United States
Increase in hair density assessed by Canfield HairMetrix® Phototrichogram Analysis
Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months of application of Xtressé™ serum. Measurements of density as measured hair per cm².
Time frame: From enrollment to end of treatment at 4 months
Hair Density changes measured by SOCAi
Images will be captures using the SOCAI system at baseline and Days, 30, 60, 90, and 120 to evaluate hair density changes.
Time frame: From enrollment to the end of the study at 4 months
Increase in hair thickness assessed via Canfield HairMetrix® Phototrichogram Analysis
Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months after applying Xtressé™ Serum. Measurements of follicular unit vellus/terminal ratio.
Time frame: From enrollment to the end of treatment at 4 months
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 application of serum
Time frame: From first treatment until the end of treatment at 4 months
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