Study Evaluating the Effects of Dietary Supplement on Hair Thickness and Hair Strength in Individuals With Self-Perceived Thinning Hair

NCT06605768 | Completed Results

• 1 other identifier: Nutra 1-0602
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The Nutra Harmony "Biotin, Collagen \& Keratin Beauty Complex" is an oral food/dietary supplement specifically designed to promote hair growth for people suffering from temporary thinning hair. The hypothesis of this clinical research study is that the ingestion of "Biotin, Collagen \& Keratin Beauty Complex" for over a three (3) month period will strengthen the hair and increase hair thickness by promoting the growth of terminal hairs in subjects, ages 21-50 years of age with self-perceived thinning hair associated with poor diet, stress, hormonal influences when compared to using the placebo tablet.

Conditions

Hair Thinning

Keywords

Hair thinning; hair thickness; hair strength; hair falling; women; oral supplement

Outcome Measures

Primary Outcomes (1)

• Hair Shedding (1-2 Hairs Per Unit)

  Hair shedding was assessed by trichoscopic evaluation of the target scalp area. The endpoint reflects the proportion of participants meeting the criterion of 1-2 shed hairs per follicular unit at the specified time point.

  Day 90

Secondary Outcomes (4)

• Hair Thinning

  90 Days

• Increase in the Amount of Vellus Hair Compared to Mature Hairs

  90 Days

• Increased Distance Between Units

  90 Days

• Inflammatory Processes in the Scalp and Blood Vessels

  90 Days

Study Arms (2)

Group Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo product

Group Treatment

ACTIVE COMPARATOR

Dietary Supplement: Complex with Biotin, Collagen, Keratin, Hyaluronic Acid.

Interventions

Complex with Biotin, Collagen, Keratin, Hyaluronic Acid. DIETARY_SUPPLEMENT

Biotin, Collagen \& Keratin Beauty Complex" 30,000 mcg, 60 capsules, oral route of administration.

Group Treatment

Placebo product DIETARY_SUPPLEMENT

Placebo, 60 capsules, oral route of administration

Group Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals, ages 21-50 years of age.
• Clinically-determined general good health as determined by responses to the initial study assessment.
• Individuals with self-perceived thinning hair associated with poor diet, stress, hormone influences.
• Individuals willing to maintain their normal hair shampooing frequency.
• Individuals willing to add the provided oral supplement to their current daily routine.
• Individuals willing to not substantially change their current diet, medications, or exercise routines for the duration of the study. If a subject receives physician guidance during the study to change diet, medications, or exercise routine, the subject will need to notify the clinic as soon as possible.
• Individuals willing to undergo a physical exam to include height, weight, blood pressure, pulse, general physical findings, scalp exam and blood sample collection.
• Individuals with Fitzpatrick I-IV photo skin types.
• Willingness to have digital photography of the target area and scalp for hair counts at Visits 1, 2, 3, 4, 5, 6.
• Willingness to have their hair washed (shampooed) over a sink containing cheesecloth for hair shedding counts at Visit 1, 2, 3, 4, 5, 6.
• Willingness to maintain a consistent haircut and hair color throughout the 3-months study period and to come to visits with clean (shampoo must be done 24 hours or more prior to the visit) and dry hair.
• Willingness of subjects who have color treated hair 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 Visit 2, 3 ,4 ,5, 6).
• Provision of signed and dated informed consent form.

You may not qualify if:

• Individuals with a known history of intolerance or allergy to fish, seafood/shellfish or acerola.
• Individuals with any known allergy or sensitivity to any shampoo/conditioner.
• Females who are nursing, pregnant, planning to become pregnant during the study.
• Individuals with known stressful incident within the last six months (i.e. death in family, miscarriage).
• Individuals who are participating on any clinical research study at another research center or doctor\'s office.
• Females who have recently (within the last 6 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 (6 months or longer) in order to be eligible for the study.
• Individuals currently using light therapy to treat thinning hair.
• Individuals who have regularly used Rogaine (Minoxidil) within the last 3 months.
• Individuals currently using any other biotin/keratin/collagen supplements.
• Individuals who have used prescription drugs known to affect the hair growth cycle within the last 6 months (e.g., hormone-based birth control for less than 6 months, cyproterone acetate, Aldactone/spironolactone, Finasteride or any 5-alpha-reductase inhibitor).
• Individuals suffering from other hair loss disorders, such as alopecia areata, scarring alopecia, androgenetic alopecia and telogen effluvium as determined on initial study assessment by the Investigator.
• Individuals with self-reported uncontrolled diseases (i.e. diabetes, hypertension, hyperthyroidism, hypothyroidism, etc.). Medical conditions that are under control with or without treatment will be considered on an individual basis by the Investigators.
• Individuals with self-reported active hepatitis, immune deficiency, HIV or autoimmune disease.
• Individuals having a known active dermatologic condition which, in the opinion of the examining Investigators, might place the subject at a greater risk or interfere with clinical evaluations (e.g., seborrheic dermatitis, psoriasis, atopic dermatitis, advanced skin cancer, etc.).

Sponsors & Collaborators

• Nutra Harmony LLC: lead

Study Sites (1)

Limited Liability Company Treatment and Diagnostic Center ADONIS Plus

Kyiv, Ukraine

Location

Related Publications (2)

• Thom E. Efficacy and tolerability of Hairgain in individuals with hair loss: a placebo-controlled, double-blind study. J Int Med Res. 2001 Jan-Feb;29(1):2-6. doi: 10.1177/147323000102900101.

  PMID: 11277343 BACKGROUND

• Williamson D, Gonzalez M, Finlay AY. The effect of hair loss on quality of life. J Eur Acad Dermatol Venereol. 2001 Mar;15(2):137-9. doi: 10.1046/j.1468-3083.2001.00229.x.

  PMID: 11495520 BACKGROUND

MeSH Terms

Conditions

Alopecia

Interventions

Biotin; Collagen; Keratins; Hyaluronic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins; Intermediate Filament Proteins; Cytoskeletal Proteins; Glycosaminoglycans; Polysaccharides; Carbohydrates

Limitations and Caveats

Results are based on participants with available Day 90 assessments (Placebo n=39, Treatment n=38). Three participants did not complete the study (adverse events n=2; lost to follow-up n=1) and were not included in the Day 90 analysis, which may introduce attrition bias and limits generalizability.

Results Point of Contact

• Title: Prof. Olga Gyrina
• Organization: Limited Liability Company Treatment and Diagnostic Center ADONIS Plus, Outpatient Department

info@adonis-international.com

+19702136830

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 20, 2024
• Study Start: February 19, 2024
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: February 3, 2026
• Results First Posted: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)