Actively Recruiting

Phase Not Applicable
Age: 28Years - 65Years
FEMALE
Healthy Volunteers
NCT07041489

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

Led by The Center for Clinical and Cosmetic Research · Updated on 2025-06-27

85

Participants Needed

2

Research Sites

44 weeks

Total Duration

On this page

Sponsors

T

The Center for Clinical and Cosmetic Research

Lead Sponsor

R

Restore Biologics Holdings, Inc. dba Xtressé

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 28Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 current diet, medications, exercise, shampooing, and color treatments during the study.
  • Ability and willingness to comply with the study protocol, including regular visits and product use.
  • Provide written informed consent, including consent to use photographs for study data.
  • For women of childbearing potential, negative pregnancy test at screening and commitment to effective contraception throughout the study.
Not Eligible

You will not qualify if you...

  • Pregnant, breastfeeding, or planning pregnancy.
  • Hormonal therapy changes within 6 months before and during the study.
  • Use of medical hair loss treatments (e.g., Minoxidil, Dutasteride, Finasteride, laser therapy) within 3 months before and during the study.
  • Micro-needling, PRP, or other scalp physical treatments within 6 months before and during the study.
  • Use of GLP-1 inhibitors (e.g., Semaglutide) within 6 months before and during the study.
  • Known uncontrolled health conditions (e.g., thyroid disease, anemia) that may affect study outcomes.
  • Sensitivity to any ingredients in the study treatments.
  • Unwillingness or inability to follow study rules or complete the study.
  • Any other medical conditions or findings that exclude participation.
  • Use of experimental drugs, biologics, or devices within 12 weeks before screening.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Skin Wellness Dermatology

Birmingham, Alabama, United States, 35209

Actively Recruiting

2

Center for Clinical and Cosmetic Research

Aventura, Florida, United States, 33180

Actively Recruiting

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Research Team

M

Mark S. Nestor, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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