RECRUITING

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

Description

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.

Conditions

Hair Thinning
Talk to us

Related Conditions:

Hair Thinning

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Hair Thinning
Intervention / Treatment

-

Contacts and Locations

Birmingham

Skin Wellness Dermatology, Birmingham, Alabama, United States, 35209

Aventura

Center for Clinical and Cosmetic Research, Aventura, Florida, United States, 33180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

28 Years to 65 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

The Center for Clinical and Cosmetic Research,

Danielle Leavitt, STUDY_DIRECTOR, Restore Biologics Holdings, LLC

Study Record Dates

2026-03-30