NCT07041489

Evaluating the Combined Use of Supplement and Serum in Promoting Hair Growth in Women With Self-perceived 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: The Center for Clinical and Cosmetic Research · Academic / Other
• Sex: Female
• Age: 28 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to test how safe and effective it is to improve hair growth using an active gummy and serum combination treatment when compared to an inactive treatment combination in women with self-perceived thinning hair. The main questions this trial aims to answer are: * to confirm using photograph analytics, how much hair growth has increased in a marked area when using active treatment versus inactive treatment, and * participants assessment and satisfaction with the hair growth using scaled assessments. Participants who qualify will be asked to complete 6 to 7 visits after voluntarily consent has been given. The study is divided into two parts. In Part A participants will be randomly given either active or inactive treatment to use over 3 months. After 3 months, all participants will enter Part B of the study and will be given active treatment to use over the final 6 months of the study.

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, laboratory assessments and pregnancy test collection) * 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 and take gummy treatment daily, including completing 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 female adult between 28 to 65 years of age * 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 treatments 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 A relatively small area will be shaved off-center and top of the scalp for a dot-tattoo placement and this marked area will be used for clinical assessments throughout the study. 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.

Conditions

• Hair Thinning

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Active Comparator- Xtressé™ Supplement and Serum	Participants will receive 3 month supplies 3 times during the study. Participants will apply serum and take supplements daily. Participants in the Intervention group will receive Xtressé™ Supplements and Serum in Part A and Part B of the study. Participants in the Placebo Group will receive Xtressé™ Supplement and Serum in Part B of the study only.
DIETARY_SUPPLEMENT	Placebo Comparator- Placebo Supplement and Serum	Participants will receive 3 month supplies 3 times during the study. Participants will apply serum and take supplements daily. Participants in the Placebo Group will receive Placebo Supplement and Serum in Part A of the study only.

Timeline

• Start date: 2025-05-20
• Primary completion: 2026-03-20
• Completion: 2026-03-30
• First posted: 2025-06-27
• Last updated: 2025-06-27

Locations

2 sites across 1 country: United States