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

The Center for Clinical and Cosmetic Research · with Restore Biologics Holdings, Inc. dba Xtressé, Xtressé (TM) · NCT07041489

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 28–65 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
85
US sites recruiting
2
Study start
May 20, 2025
Record last updated
June 27, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Active Comparator- Xtressé™ Supplement and Serum; Placebo Comparator- Placebo Supplement and Serum

Conditions: Hair Thinning

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Skin Wellness Dermatology

    Birmingham, AL 35209

    Site contact: Clinical Coordinator · (205) 871-7332

  • Center for Clinical and Cosmetic Research

    Aventura, FL 33180

    Site contact: Clinical Coordinator · 305-933-6716 · info@centerforclinicalandcosmeticresearch.com

Study contacts (from the official record)

  • Mark S. Nestor, MD, PhD · 305-933-6716 · info@centerforclinicalandcosmeticresearch.com
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Evaluating the Combined Use of Supplement and Serum in Promoting… (NCT07041489) | Bored Studies