A 6-month, Randomized, Double-blind, Placebo Controlled Study Evaluating the Efficacy and Safety of USPlus DERM to Promote Hair Growth in Men and Women With Self-perceived Thinning Hair.

NCT06920758 | Active Not Recruiting

• 1 other identifier: VAL-HT-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to substantiate the effectiveness and safety of USPlus® DERM for self-perceived thinning hair compared to placebo in healthy men and women ages 25-65 over the course of six months of continued use. Participants will be asked to have attend three office visits, one phone call, have photos taken of their hair and answer questionnaires related to their thinning hair.

Conditions

Thinning Hair

Keywords

Thinning hair, hair loss, hair shedding

Outcome Measures

Primary Outcomes (3)

• Change in terminal hair counts from Baseline to Day 180 using the Canfield HairMetrix system.

  Change in terminal hair counts from Baseline to Day 180 using the Canfield HairMetrix system. A statistically significant increase in count at Day 180 in comparison to Baseline for subjects who were assigned to the Active compared to subjects who were assigned to the placebo indicates an improvement for the indicated parameter.

  Baseline to Day 180

• Change in vellus hair counts from Baseline to Day 180 using the Canfield HairMetrix system.

  Change in vellus hair counts from Baseline to Day 180 using the Canfield HairMetrix system.

  Baseline to Day 180

• Change in total hair counts from Baseline to Day 180 using the Canfield HairMetrix system.

  Change in total hair counts from Baseline to Day 180 using the Canfield HairMetrix system. A statistically significant increase in count at Day 180 in comparison to Baseline for subjects who were assigned to the Active compared to subjects who were assigned to the placebo indicates an improvement for the indicated parameter.

  Baseline to Day 180

Secondary Outcomes (11)

• Change in terminal to vellus ratio using the Canfield HairMetrix system from Baseline to Day 180.

  Baseline to Day 180

• Change in average hairs per follicular unit using the Canfield HairMetrix system from Baseline to Day 180.

  Baseline to Day 180

• Change in average hair width (μm) using the Canfield HairMetrix system from Baseline to Day 180.

  Baseline to Day 180

• Change in follicular units per cm² using the Canfield HairMetrix system from Baseline to Day 180.

  Baseline to Day 180

• Change in inter-follicular mean distance (mm) using the Canfield HairMetrix system from Baseline to Day 180.

  Baseline to Day 180

Study Arms (2)

USPlus DERM softgels

ACTIVE COMPARATOR

USPlus® DERM Bioactive Fatty Acids 160 mg Softgels

Dietary Supplement: USPlus DERM Bioactive Fatty Acids 160 mg Softgels

Placebo softgels

PLACEBO COMPARATOR

Placebo Softgels

Other: Placebo softgel

Interventions

USPlus DERM Bioactive Fatty Acids 160 mg Softgels DIETARY_SUPPLEMENT

USPlus® DERM Bioactive Fatty Acids (160 mg) Ingredient List (Per Softgel) Active: 100% Concentrated Lipidosterolic Extract of Saw Palmetto (Serenoa repens). Shell: Bovine Gelatin, Glycerin, Water

USPlus DERM softgels

Placebo softgel OTHER

Placebo Ingredient List: Palm oil Gelatin Glycerin Water Caramel color

Placebo softgels

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males and females of all Fitzpatrick Skin Types between 25 and 65 years of age.
• Subjects must be willing to provide verbal understanding and sign an Informed Consent Form, HIPAA Form and Photography Release Form approved by the Institutional Review Board.
• Subjects must be in general good health, as determined by the Investigator.
• Subjects with self-perceived hair thinning as determined on initial study assessment by the Investigator (excluding patients with medically diagnosed telogen effluvium).
• Subjects willing to undergo a brief physical exam to include height, weight, blood pressure, pulse, physical scalp exam and basic systems evaluation (Skin, Respiratory, Cardiovascular, Gastrointestinal, Endocrine, Neurological and Musculoskeletal systems) by the Investigator.
• Male subjects with frontal and/or vertex patterns I, II, IIA, III, III vertex and IV during the physical scalp exam by the Investigator rated based on the Norwood Classification Scale.
• Female subjects with I-1, I-2 and I-3 during the physical scalp exam by the Investigator rated based on the Savin Pictorial Scale.
• Subjects willing to not substantially change their current diet, medications, dietary supplements and exercise routines for the duration of the study. If a subject receives physician guidance during the study to change diet, medications, supplements or exercise routine, the subject will need to notify the clinic as soon as possible.
• Females of child bearing potential (FOCBP) must be willing to have a urine pregnancy test and practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months as of the start of the study, intrauterine device, condom with spermicide, diaphragm with spermicide, implant, NuvaRing®, injection, transdermal patch or abstinence.) Females on birth control pills must have taken the same type of pill for at least 3 months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least 3 months prior to the start of the study. The initiation of birth control should not have been associated with the initiation of hair loss/thinning.
• FOCBP must have a negative urine pregnancy test at the Baseline Visit.
• Subjects willing to have 2-D digital photography of the entire head/hair region for overall evaluation of general hair growth and quality by the Investigator.
• Subjects willing to have digital trichoscopy photography of the target site areas on the scalp for analysis of hair counts and other hair measurements.
• Subjects must be willing and able to complete and understand the rating questionnaires.
• Subjects must maintain a consistent length, cut, style and color throughout the six (6) month study period.
• Subjects who have color treated hair must be willing to have the color treatment performed at the same time interval prior to each visit (i.e. If on Visit 1 the color treatment was done one week prior then the color treatment is expected to occur at a similar interval of one week prior to Visits 2 and 3).

You may not qualify if:

• Subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study.
• Male subjects with male pattern hair loss with frontal and/or vertex patterns IIIA, IVA, V, VA, VI, VII ratings using the Norwood Classification Scale as determined during the physical scalp exam by the Investigator.
• Female subjects with I-4, II-1,II-2, III Advanced and Frontal ratings using the Savin Pictorial Scale as determined during the physical scalp exam by the Investigator.
• Subjects who have had a hair transplant.
• Subjects with hair extensions or who are planning on getting hair extensions during the duration of the study.
• Subjects with any known allergy or sensitivity to any shampoo and/or conditioner.
• Subjects with a known stressful incident within the last six months (e.g. death in family, miscarriage).
• Subjects who have recently (within the last 3 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (3 months or longer) in order to be eligible for the study.
• Subjects using Low Level Laser Therapy (LLLT) or other light therapy to treat thinning hair in the last 3 months.
• Subjects who have regularly used Rogaine (Minoxidil), Nioxin and /or Finasteride or undergone any other hair or scalp treatments within the last 3 months.
• Subjects who have used prescription drugs known to affect the hair growth cycle within the last 3 months (e.g., hormone-based birth control for less than 3 months, cyproterone acetate, aldactone/spironolactone or any 5-alpha-reductase inhibitor).
• Subjects who have regularly used anti-androgenic therapies (i.e. spironolactone, flutamide, cyproterone acetate, progesterone and/or bicalutamide) or undergone any other hair or scalp treatments within the last 3 months.
• Subjects suffering from other hair loss disorders, such as alopecia areata, scarring alopecia, androgenetic alopecia and telogen effluvium as determined during initial study assessment and physical scalp exam by the Investigator.
• Subjects with self-reported uncontrolled diseases (i.e. diabetes, hypertension, hyperthyroidism, hypothyroidism, etc.). Whether medical conditions are under control with or without treatment will be assessed on an individual basis by the Investigator based on her medical and clinical expertise.
• Subjects with self-reported active hepatitis, immune deficiency, HIV or autoimmune disease.

Sponsors & Collaborators

• Ablon Skin Institute Research Center: lead
• U.S. Nutraceuticals, Inc. dba Valensa International: collaborator

Study Sites (1)

Ablon Skin Institute and Research Center

Manhattan Beach, California, 90266, United States

Location

Related Publications (1)

• Ablon G. The Safety and Efficacy of a Proprietary Bioactive Fatty Acids Extract From Saw Palmetto (Serenoa repens) for Promoting Hair Growth and Reducing Hair Loss in Adults With Self-Perceived Thinning Hair: 90-Day Results. J Cosmet Dermatol. 2025 Dec;24(12):e70585. doi: 10.1111/jocd.70585.

  PMID: 41319217 DERIVED

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

• Glynis Ablon, MD, FAAD, PI

  Ablon Skin Institute Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start: December 16, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)