Combined gummy supplement and topical serum to promote hair growth in women with thinning hair

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

This trial will test whether taking an active gummy supplement and applying an active serum helps women with self-perceived thinning hair grow more hair compared with inactive products.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 85 (estimated)
• Ages: 28 Years to 65 Years
• Sex: Female
• Sponsor: The Center for Clinical and Cosmetic Research (Academic / other)
• Locations: 2 sites (Birmingham, Alabama and 1 other locations)
• Trial ID: NCT07041489 on ClinicalTrials.gov

What this trial studies

This interventional study enrolls women aged 28–65 with self-perceived thinning hair (Ludwig I–II) and randomizes participants in Part A to either an active gummy-plus-serum combination or matching placebo for three months. Hair growth will be measured objectively by standardized photography and hair density measurements in a small shaved scalp area, along with participant satisfaction ratings and treatment diaries; participants then receive active treatment for an additional six months in Part B. The protocol includes 6–7 clinic visits for exams, labs, pregnancy testing, and documented photography, and participants must adhere to stable hair-care, medication, and diet routines. Safety monitoring will record adverse events and skin reactions throughout the study period.

Who should consider this trial

Good fit: Women aged 28–65 with consistent self-perceived thinning hair corresponding to Ludwig Scale I or II who can attend clinic visits, allow scalp photography and a small shaved area, and agree to follow study rules are ideal candidates.

Not a fit: People with more advanced hair loss beyond Ludwig II, those pregnant or breastfeeding, anyone allergic to the product ingredients, or those unwilling to follow the protocol are unlikely to benefit from this study regimen.

Why it matters

Potential benefit: If successful, the combination could increase visible hair density and improve patient satisfaction with hair appearance.

How similar studies have performed: Topical agents and some oral hair supplements have shown modest benefits in prior studies, but this specific gummy-plus-serum combination and formulation is relatively untested in rigorous randomized protocols.

Eligibility criteria

Inclusion Criteria:

* Female adults between 28-65 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 their current diet, medications, exercise routines, hair shampooing, and color treatment frequency for the duration of the study.
* Ability and willingness to comply with the study protocol including regular visits and product application.
* Written informed consent obtained, including written consent to allow photographs to be used as part of the study data and documentation.
* For females of childbearing potential, a negative pregnancy test at screening and commitment to effective contraception throughout the study (oral / implant/ injectable/ transdermal contraceptives, intrauterine device, condom, diaphragm, abstinence, or a monogamous relationship with a partner who has had a vasectomy) to avoid pregnancy-related hormonal changes affecting hair density.

Exclusion Criteria:

* Pregnant or lactating or planning to become pregnant.
* Changes in hormonal therapy within 6 months prior to enrollment and throughout the study.
* Use of other medical hair loss treatments (e.g., Minoxidil, Dutasteride, Finasteride, laser or light therapy) within 3 months prior to study start and throughout the study.
* Micro-needling, PRP, or any other physical treatment modality on the scalp (within 6 months prior to study start and throughout the study).
* Use of GLP-1 inhibitors (e.g., Semaglutide) within 6 months prior to study start and throughout the study.
* Known uncontrolled health conditions (e.g., thyroid disease, anemia) that could confound study outcomes.
* Known sensitivity to any of the ingredients in the study medication.
* In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions and requirements of the protocol and complete the study.
* Subject has any conditions, findings in history, physical exam or laboratory assessments, which in the opinion of the investigator, would exclude the subject from continuing in this study.
* Treatment with an experimental drug, biologic or device within 12 weeks of the screening visit.

Where this trial is running

Birmingham, Alabama and 1 other locations

• Skin Wellness Dermatology — Birmingham, Alabama, United States (Recruiting)
• Center for Clinical and Cosmetic Research — Aventura, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Mark S. Nestor, MD, PhD

Conditions Hair Thinning; hair thinning; thinning hair; hair loss; thin hair