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Recruiting NCT07041489

NCT07041489 Evaluating the Combined Use of Supplement and Serum in Promoting Hair Growth in Women With Self-perceived Thinning Hair

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Clinical Trial Summary
NCT ID NCT07041489
Status Recruiting
Phase
Sponsor The Center for Clinical and Cosmetic Research
Condition Hair Thinning
Study Type INTERVENTIONAL
Enrollment 85 participants
Start Date 2025-05-20
Primary Completion 2026-03-20

Eligibility & Interventions

Sex Female only
Min Age 28 Years
Max Age 65 Years
Study Type INTERVENTIONAL
Interventions
Active Comparator- Xtressé™ Supplement and SerumPlacebo Comparator- Placebo Supplement and Serum

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 85 participants in total. It began in 2025-05-20 with a primary completion date of 2026-03-20.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

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.

Contact & Investigator

Central Contact

Mark S. Nestor, MD, PhD

✉ info@centerforclinicalandcosmeticresearch.com

📞 305-933-6716

Principal Investigator

Danielle Leavitt

STUDY DIRECTOR

Restore Biologics Holdings, Inc. dba Xtressé

Frequently Asked Questions

Who can join the NCT07041489 clinical trial?

This trial is open to female participants only, aged 28 Years or older, up to 65 Years, studying Hair Thinning. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07041489 currently recruiting?

Yes, NCT07041489 is actively recruiting participants. Contact the research team at info@centerforclinicalandcosmeticresearch.com for enrollment information.

Where is the NCT07041489 trial being conducted?

This trial is being conducted at Birmingham, United States, Aventura, United States.

Who is sponsoring the NCT07041489 clinical trial?

NCT07041489 is sponsored by The Center for Clinical and Cosmetic Research. The principal investigator is Danielle Leavitt at Restore Biologics Holdings, Inc. dba Xtressé. The trial plans to enroll 85 participants.

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