Study Evaluating the Effect of Nutra Harmony "Biotin, Collagen and Keratin Beauty Complex" Dietary Supplement on Hair Thickness and Hair Strength in Adults With Self-Perceived Thinning Hair

NCT07520019 | Active Not Recruiting

• 1 other identifier: Nutra 2-1216
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The Nutra Harmony "Biotin, Collagen and Keratin Beauty Complex" is an oral food/dietary supplement specifically designed to Promote hair growth for people suffering from temporary thinning hair. The main goal of this clinical trial is to evaluate the efficacy of two different doses of the study supplement (with 5,000 mcg vs 10,000 mcg biotin). A product formula with 10,000 mcg of biotin per serving was clinically tested and demonstrated results in strengthening hair and increasing hair thickness by promoting the growth of terminal hairs in subjects aged 21 to 50 years, with self-perceived thinning hair associated with poor diet, stress, and hormonal influences, compared with the placebo tablet.

Conditions

Hair Thinning

Keywords

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

Outcome Measures

Primary Outcomes (2)

• To evaluate the efficacy of two different doses of the study supplement (5,000 mcg vs 10,000 mcg biotin) in adults with self-perceived thinning hair.

  Hair count in the target area of the scalp - number of terminal and vellus hairs in the primary target area, measured by phototrichogram using dermatoscopy. This serves as the main efficacy assessment.

  Baseline (Visit 1) and End of Study (Visit 4, Day 90)

• To evaluate the efficacy of two different doses of the study supplement (5,000 mcg vs 10,000 mcg biotin) in adults with self-perceived thinning hair.

  Hair count in predefined control points of the scalp - number of terminal and vellus hairs in additional standardized control points, measured via dermatoscope phototrichogram and read by the investigator. This provides supplementary data to support the primary efficacy assessment.

  Baseline (Visit 1) and End of Study (Visit 4, Day 90)

Secondary Outcomes (3)

• To assess the effect of two different doses of the supplement on hair shedding, quality of life, and participant self-assessment in adults with self-perceived thinning hair.

  Visits 2 and 3 (Day 30 and 60) and End of Study (Visit 4, Day 90)

• To assess the effect of two different doses of the supplement on hair shedding, quality of life, and participant self-assessment in adults with self-perceived thinning hair.

  Baseline (Visit 1) and End of Study (Visit 4)

• To assess the effect of two different doses of the supplement on hair shedding, quality of life, and participant self-assessment in adults with self-perceived thinning hair.

  End of Study (Visit 4, Day 90)

Study Arms (2)

Low Dose 5,000 mcg Biotin Group

ACTIVE COMPARATOR

Dietary Supplement: Complex with Biotin 5,000 mcg, Collagen, Keratin and Hyaluronic Acid.

High Dose 10,000 mcg Biotin Group

ACTIVE COMPARATOR

Dietary Supplement: Complex with Biotin 10,000 mcg, Collagen, Keratin and Hyaluronic Acid.

Interventions

Complex with Biotin 5,000 mcg, Collagen, Keratin and Hyaluronic Acid. DIETARY_SUPPLEMENT

Biotin, Collagen, and Keratin Beauty Complex 25,000 mcg, 60 capsules, oral route of administration. (Low Dose Biotin, 5,000 mcg per Serving)

Low Dose 5,000 mcg Biotin Group

Complex with Biotin 10,000 mcg, Collagen, Keratin and Hyaluronic Acid. DIETARY_SUPPLEMENT

Biotin, Collagen, and Keratin Beauty Complex 30,000 mcg, 60 capsules, oral route of administration. (High Dose Biotin, 10,000 mcg per Serving)

High Dose 10,000 mcg Biotin Group

Eligibility Criteria

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

You may qualify if:

• Participants must meet all of the following criteria:
• Adults aged 21-50 years.
• Generally healthy, as determined by medical history, physical exam, and available laboratory results from Visit 1 (Day -1/Day 0).
• Self-perceived thinning hair associated with diet, stress, or hormonal influences.
• Willingness to maintain the usual hair care routine, including shampoo frequency, and consistent haircut/color during the study.
• Willingness to take the study supplement daily as instructed.
• Willingness to avoid major changes in diet, medications, or exercise during the study and to notify the clinic of any changes.
• Willingness to undergo all required assessments, including physical exam, vital signs, hematology, urine pregnancy test (if applicable), scalp exam, hair photography, and completion of the Hair Shedding Diary.
• Fitzpatrick skin types I-IV.
• Ability and willingness to provide written informed consent.

You may not qualify if:

• Participants will be excluded if they meet any of the following:
• Known allergy or intolerance to any component of the study supplement (e.g., biotin, keratin, collagen, fish/seafood, acerola).
• Known allergy or sensitivity to hair care products specified for use in the study.
• Pregnant, breastfeeding, or planning to become pregnant during the study period.
• Significant stress event (e.g., death in family, miscarriage) within the past 6 months.
• Participation in another clinical study concurrently.
• Initiation of hormonal therapy within the past 6 months (stable use for at least 6 months allowed).
• Current use of light therapy for hair loss.
• Use of minoxidil or other hair growth medications within the last 3 months.
• Current use of biotin, keratin, collagen, or similar supplements.
• Use of prescription medications known to affect hair growth within the last 6 months.
• Hair disorders other than self-perceived thinning hair (e.g., alopecia areata, scarring alopecia, androgenetic alopecia, telogen effluvium).
• Uncontrolled chronic diseases (e.g., diabetes, hypertension, thyroid disorders). Stable, well-controlled conditions may be allowed at the investigator's discretion.
• Active hepatitis, immune deficiency, human immunodeficiency virus (HIV) infection, or autoimmune disease.
• Active dermatologic conditions that may interfere with assessments or increase risk (e.g., severe seborrheic dermatitis, psoriasis, advanced skin cancer).

Sponsors & Collaborators

• Nutra Harmony LLC: lead

Study Sites (1)

Limited Liability Company Treatment and Diagnostic Center ADONIS Plus

Kyiv, Kyiv Oblast, 02002,, Ukraine

Location

Related Publications (8)

• A Review of the Use of Biotin for Hair Loss - PMC: comprehensive analysis finds limited evidence supporting biotin's efficacy in healthy individuals; benefits more evident in deficiency-related hair loss.

  BACKGROUND

• Mockenhaupt M, et al. A review of the use of biotin for hair loss. Skin Appendage Disord. [Review]. Although biotin supplementation is widely used, evidence in healthy individuals is limited and largely confined to cases of deficiency.

  BACKGROUND

• Ablon G. Double-blind, placebo-controlled study evaluating the efficacy of an oral supplement in women with self-perceived thinning hair. J Clin Aesthet Dermatol. 2012;5(11):28-34.

  BACKGROUND

• Williamson D, Gonzalez M, Finlay AY. The effect of hair loss on quality of life. J Eur Acad Dermatol Venereol. 2001;15:137-139.

  BACKGROUND

• Harrison S, Bergfeld W. Diffuse hair loss: its triggers and management. Cleveland Clin J Med. 2009;76(6):361-367.

  BACKGROUND

• Finner AM. Nutrition and hair: deficiencies and supplements. Dermatol Clin. 2013;31:167-172.

  BACKGROUND

• Patel DP, Swink SM, Castelo-Soccio L. Nutritional supplementation for hair loss: a systematic review. J Drugs Dermatol. 2017;16(12):1167-1172.

  BACKGROUND

• Almohanna HM, Ahmed AA, Tsatalis JP, Tosti A. The role of vitamins and minerals in hair loss: a review. Dermatol Ther (Heidelb). 2019;9:51-70.

  BACKGROUND

Related Links

• Related Info

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

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: April 2, 2026
• First Posted: April 9, 2026
• Study Start: January 15, 2026
• Primary Completion: May 1, 2026
• Study Completion: June 15, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)