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

NCT07041489 | Recruiting

• 1 other identifier: CCCR 03-2025
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

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

Keywords

hair thinning; thinning hair; hair loss; thin hair

Outcome Measures

Primary Outcomes (3)

• Increase in hair density (hairs per cm²) measured as the within-subject change from baseline to Month 3, assessed via Canfield HairMetrix® phototrichogram analyses.

  Quantitative hair measurements calculated by analyzing the participants digital images.

  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.

  Quantitative hair measurements calculated by analyzing the participants digital images.

  Up to 9 months

• Participant self-assessment of hair growth and satisfaction, collected via validated questionnaires.

  Observations and changes noted in hair loss graded on a scale of 0 to 4, with 0 as none and 4 as a very severe outcome. Observations and changes noted in quality of life based on hair loss, outcomes graded between extremely affected and not at all.

  Up to 9 months

Secondary Outcomes (2)

• Increase in hair density as measured by SOCAi

  Up to 9 months

• Improvements in hair quality (e.g., thickness, strength) and volume, evaluated by blinded investigator assessments

  Up to 9 months

Study Arms (3)

Intervention Group - Part A and Part B

ACTIVE COMPARATOR

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.

Dietary Supplement: Active Comparator- Xtressé™ Supplement and Serum

Placebo Group- Part A

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo Comparator- Placebo Supplement and Serum

Placebo Group- Part B

ACTIVE COMPARATOR

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

Dietary Supplement: Active Comparator- Xtressé™ Supplement and Serum

Interventions

Active Comparator- Xtressé™ Supplement and Serum DIETARY_SUPPLEMENT

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.

Intervention Group - Part A and Part B; Placebo Group- Part B

Placebo Comparator- Placebo Supplement and Serum DIETARY_SUPPLEMENT

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.

Placebo Group- Part A

Eligibility Criteria

• Age: 28 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Center for Clinical and Cosmetic Research: lead
• Restore Biologics Holdings, Inc. dba Xtressé: collaborator
• Xtressé (TM): collaborator

Study Sites (2)

Skin Wellness Dermatology

Birmingham, Alabama, 35209, United States

RECRUITING

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Danielle Leavitt

  Restore Biologics Holdings, Inc. dba Xtressé

  STUDY DIRECTOR

Central Study Contacts

Mark S. Nestor, MD, PhD

CONTACT

305-933-6716; info@centerforclinicalandcosmeticresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded in Part A followed by Open-label in Part B of the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 27, 2025
• Study Start: May 20, 2025
• Primary Completion: March 20, 2026
• Study Completion: March 30, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

US (2)