Recruiting

Active Gummy & Serum

Sponsor:

The Center for Clinical and Cosmetic Research

Code:

NCT07041489

Conditions

Hair Thinning

Eligibility Criteria

Sex: Female

Age: 28 - 65

Healthy Volunteers: Accepted

Interventions

Active Comparator- Xtressé™ Supplement and Serum

Placebo Comparator- Placebo Supplement and Serum

Study Details

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.

Conditions

Hair Thinning

Study ID

NCT07041489

Start date

May 20, 2025

Status verified date

Jun, 2025

Completion date

Mar 30, 2026

Anticipated

Primary completion date

Mar 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 28 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

85 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intervention Group - Part A and Part B

43 subjects will be randomized to this group and will receive Xtressé™ supplements + serum during the double-blinded Part A and open-label Part B of the study.

placebo comparator: Placebo Group- Part A

42 subjects will be randomized to this group and will receive Placebo supplements and serum in only Part A of the study.

active comparator: Placebo Group- Part B

42 subjects will enter the open-labelled Part B of the study and will receive Xtressé™ supplements + serum.

Interventions

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.

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.

Primary outcome measure

  • Increase in hair density (hairs per cm²) measured as the within-subject change from baseline to Month 3, assessed via Canfield HairMetrix® phototrichogram analyses. [ Time Frame: an average of 3 months ]
  • Increase in hair density (hairs per cm²) Measured as the within-subject change from baseline to Month 9, assessed via Canfield HairMetrix® phototrichogram analyses. [ Time Frame: Up to 9 months ]
  • Participant self-assessment of hair growth and satisfaction, collected via validated questionnaires. [ Time Frame: Up to 9 months ]

Central Contacts and Locations

Central contacts

Mark S. Nestor, MD, PhD

305-933-6716info@centerforclinicalandcosmeticresearch.com

Locations

Skin Wellness Dermatology

Recruiting

Birmingham, Alabama, United States, 35209

Contacts

Clinical Coordinator

(205) 871-7332

Principal Investigator:

Corey L. Hartman, MD, FAAD

Center for Clinical and Cosmetic Research

Recruiting

Aventura, Florida, United States, 33180

Contacts

Clinical Coordinator

305-933-6716info@centerforclinicalandcosmeticresearch.com

Principal Investigator:

Mark S. Nestor, MD, PhD

More Information

Sponsor

The Center for Clinical and Cosmetic Research

Last update posted

Jun 27, 2025

Last verified

Jun, 2025

Keywords

  • hair thinning
  • thinning hair
  • hair loss
  • thin hair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Center for Clinical and Cosmetic Research on 2025-06-27.