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Enrolling by Invitation

NCT Number: NCT07224555

Study Evaluating Xtressé Gummy Supplement in Women With Self-Perceived Thinning Hair

The goal of this study is to determine how safe and effective it is to improve hair growth using an active gummy treatment in women with self-perceived thinning hair.

The main aims of this trial are:

1. To confirm using photographic analysis, changes in the quality, volume, and thickness of hair. 2. To gauge patient satisfaction with hair changes and application process. 3. Monitor and report any adverse events associated with the daily intake of Xtressé

Participants who qualify will complete 5 visits after voluntary consent has been given. Participants will be given a 30-day supply of the gummies at each visit over a 4-month period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Advanced Dermatology & Cosmetic Surgery, Maitland, Florida, United States

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About this study

In the study, participants will be asked to complete the following:

  • Provide basic personal information (including date of birth, gender, race and ethnicity)
  • Provide their medical/ surgical history and perform a medical exam (including but not limited to symptom-directed physical exam, skin type, vital signs, height, weight, and pregnancy test)
  • Follow study rules such as avoiding certain medications and treatments
  • Provide information on any medications, treatments or reactions that started after the study began
  • Take gummy treatment daily and complete a treatment diary
  • Allow clinical assessments and documentation of the treatment, such as photography, hair density measurements, any reactions or side effects

To qualify for this trial, participants must:

  • Be a female adult between 28 to 65 years of age
  • Have consistent self-perceived thinning hair.
  • Give voluntary written consent
  • Be willing to follow study instructions and complete study requirements, including maintaining current diet and hair care routine, not using non-approved lotions and creams on the treatments areas
  • Allow photographs of the front and top area of the scalp
  • Not be pregnant or breast feeding before and during the study and agree to use acceptable forms of birth control
  • Confirm they are not sensitive to any of the study treatment ingredients

All photographs of the treatment area collected during the study will be used as study data.

All participants have the right to refuse further participation in the study at any time.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 18-65 years with self-perceived thinning hair (confirmed by an investigator).
  • Fitzpatrick skin types I to VI.
  • Ability and willingness to comply with the study protocol.
  • Commitment to using effective contraception throughout the study if of childbearing potential.

Exclusion criteria

  • Pregnancy, nursing, or recent initiation of hormone therapy.
  • Change in other hair treatments within 3 months prior to the study.
  • Known uncontrolled health conditions (e.g., poorly controlled diabetes, hypertension).
  • History of hair or scalp disorders that could interfere with study results.
  • History of metabolic syndrome.

Treatment and study plan

Xtressé Hair Growth Gummies

Other

The nutraceutical supplement is powered by proprietary X-3 BioActive Blend and contains plant based extracts and regenerative compounds not commonly found in existing hair supplements.

Primary outcomes

  1. Hair Density Changes measured by SOCAi

    Time frame: From enrollment to the end of the study at 4 months

    Images will be captured using the the SOCAi system at baseline and Days 30, 60, 90, and 120, to evaluate hair density changes.

  2. Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis

    Time frame: From enrollment to the end of treatment at 4 months

    Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months after taking Xtressé™ Supplements. Measurements of density as measured hair per cm².

  3. Within-subject increase in hair thickness assessed via Canfield HairMetrix® Phototrichogram Analysis

    Time frame: From enrollment to the end of treatment at 4 months

    Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months after taking Xtressé™ Supplements. Measurements of follicular unit vellus/terminal ratio.

Secondary outcomes

  1. Incidence of Adverse Events associated with Treatment

    Time frame: From first treatment until the end of treatment at 4 months

    Collect and quantify the incidence of treatment-related adverse events and treatment-related serious adverse events associated with the daily intake of supplement

Other outcomes

  1. Participant self-assessment of hair improvements collected via questionnaire

    Time frame: From enrollment to the end of study at 4 months

    Observations and changes noted in hair loss graded on scale of 0 to 4 with 0 as no change and 4 as a very severe outcome.

    Observations and changes noted in quality of life based on hair loss, with outcomes graded between extremely effected to not at all.

    Observations are based on self-assessments completed at baseline and Day 120.

Sponsors and collaborators

Lead sponsor

Restore Biologics Holdings, Inc. dba Xtressé

Industry

Registry information

Official study title

Pilot Study to Evaluate the Efficacy and Safety of Xtressé™ Gummy-Based Nutraceutical Supplement in Women With Self-Perceived Thinning Hair

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 4, 2025
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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