Actively Recruiting
A Multi Center, Randomized, Double-Blind, Placebo-controlled Trial With Extension to an Open-Label Study to Evaluate the Safety and Efficacy of Xtressé Supplement + Serum Treatment Combination in Promoting Hair Growth in Women With Self-perceived Thinning Hair
Led by The Center for Clinical and Cosmetic Research · Updated on 2025-06-27
85
Participants Needed
2
Research Sites
1 weeks
Total Duration
On this page
Sponsors
T
The Center for Clinical and Cosmetic Research
Lead Sponsor
R
Restore Biologics Holdings, Inc. dba Xtressé
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combined active gummy supplement and serum treatment to promote hair growth in women who perceive their hair as thinning. This trial focuses on comparing active treatment to an inactive (placebo) combination and measures hair growth using photographic analysis and participants' satisfaction with hair improvement. The study is designed as a randomized, double-blind trial with an extension to an open-label phase. Participants will be randomly assigned to receive either the active Xtressé supplement and serum or a placebo combination during the first 3 months (Part A). After this period, all participants will receive the active treatment during the following 6 months (Part B). The treatments are applied daily, and supplies are provided in 3-month intervals. The study involves a small shaved and tattooed scalp area for consistent clinical assessment. Participants will complete 6 to 7 visits throughout the study where medical history, exams, and laboratory tests including pregnancy tests are performed. Assessments include photography, hair density measurements with Canfield HairMetrix® phototrichogram analyses, participant questionnaires on hair growth and satisfaction, and monitoring for any reactions or side effects. The total study duration is up to 9 months, and participants are asked to maintain their usual diet and hair care routines while following study instructions.
CONDITIONS
Brief Title
Evaluating the Combined Use of Supplement and Serum in Promoting Hair Growth in Women With Self-perceived Thinning Hair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female adults between 28 and 65 years of age with consistent self-perceived thinning hair
- Ludwig Scale I or II (mild to moderate thinning hair loss), assessed clinically
- Fitzpatrick Skin Types I to VI
- Agree to maintain current diet, medications, exercise routines, hair shampooing, and color treatment frequency during the study
- Ability and willingness to comply with study protocol including regular visits and daily product application
- Written informed consent obtained, including consent for photographs to be used in the study
- For females of childbearing potential, negative pregnancy test at screening and commitment to effective contraception throughout the study
You will not qualify if you...
- Pregnant, lactating, or planning to become pregnant
- Changes in hormonal therapy within 6 months prior to and during the study
- Use of other medical hair loss treatments (e.g., Minoxidil, Dutasteride, Finasteride, laser or light therapy) within 3 months prior to and during the study
- Micro-needling, PRP, or other physical scalp treatments within 6 months prior to and during the study
- Use of GLP-1 inhibitors (e.g., Semaglutide) within 6 months prior to and during the study
- Known uncontrolled health conditions such as thyroid disease or anemia that could affect study outcomes
- Known sensitivity to any ingredients in the study medication
- Any condition or findings that, in the investigator's opinion, would prevent study completion
- Treatment with an experimental drug, biologic, or device within 12 weeks before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 months
Participants will apply serum and take supplements daily for hair growth treatment. They will complete treatment diaries and allow clinical assessments such as photography and hair density measurements.
Regular visits during treatment period
Trial Site Locations
Total: 2 locations
1
Skin Wellness Dermatology
Birmingham, Alabama, United States, 35209
Actively Recruiting
2
Center for Clinical and Cosmetic Research
Aventura, Florida, United States, 33180
Actively Recruiting
Research Team
M
Mark S. Nestor, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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