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

A 3-Month, Randomized, Single-Blind, Two-Arm, Dose-Comparison 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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hair Thinning
• Intervention / Treatment: Dietary supplement: Complex with Biotin 5,000 mcg, Collagen, Keratin and Hyaluronic Acid.; Dietary supplement: Complex with Biotin 10,000 mcg, Collagen, Keratin and Hyaluronic Acid.

Detailed Description

This study is a two-arm, parallel-group, randomized, single-blind, dose-comparison trial designed to evaluate the efficacy of two doses of the study supplement (5,000 mcg vs 10,000 mcg biotin) in adults with self-perceived temporary hair thinning. The trial is powered to detect meaningful differences in hair growth between the two dose groups over a 3-month treatment period. Total trial duration for participants is approximately 3 months, with the treatment period lasting 90 days following randomization. Approximately 40 males and females, aged 21 to 50, who met all eligibility criteria, were randomized in a 1:1 ratio to receive either the 5,000 mcg or 10,000 mcg biotin dose of the study supplement.

Within the study, there were a total of 4 site visits for each participant, during which the following procedures were performed:

Visit 1: Screening/Randomization (Day -1 / Day 0) Screening assessments will be performed on Day -1. Hematology results required for eligibility evaluation will be obtained on the following day. Randomization and study drug dispensing will occur on Day 0, only after all inclusion/exclusion criteria are confirmed, including availability of laboratory results. No additional assessments will be performed on Day 0.

The following procedures will take place:

1. Signing the informed consent form (ICF);
2. Demographics recording;
3. Height and weight assessment;
4. Vital signs: pulse, systolic blood pressure (SBP), and diastolic blood pressure (DBP) after 10 minutes of rest;
5. Medical history and current medications;
6. Hematology sample collection;
7. Urine pregnancy test (for women of childbearing potential);
8. Basic physical examination: general appearance; skin, hair, nails; cardiovascular; respiratory; abdomen;
9. Dermoscopic photographs of the target scalp area (for hair count and follicle evaluation);
10. Standardized digital photographs of the target scalp area (for overall hair appearance and coverage);
11. Quality of Life Questionnaire (QoL);
12. Instruction for Hair Shedding Diary (participant-reported for the period since last visit);
13. Randomization (Day 0): participants will be randomized in a 1:1 ratio to receive one of two doses of the study product;
14. Study product dispensing (Pack 1).

Visit 2: (Day 30±3), Visit 3: (Day 60±3)

The following procedures will take place:

1. Update medical history and concomitant medications;
2. Adverse events review;
3. Hair shedding diary review (overall for the previous period);
4. Hair count in defined control points of the scalp;
5. Study product dispensing (Pack 2 at Day 30, Pack 3 at Day 60).

Visit 4: (Day 90, End of Study)

The following procedures will take place:

1. Vital signs: pulse, systolic [SBP] and diastolic [DBP] blood pressure (after 10 minutes resting);
2. Hematology;
3. Hair shedding diary review (final period);
4. Dermoscopic photographs of the target scalp area (for hair count and follicle evaluation);
5. Standardized digital photographs of the target scalp area (for overall hair appearance and coverage);
6. Hair count in defined control points;
7. Quality of Life Questionnaire;
8. Self-assessment Questionnaire. No further follow-up is required unless unresolved adverse events (AEs) exist.

The effectiveness of the treatment will be evaluated by comparing the increase in hair growth in study supplement-treated subjects, defined as the change in hair area from baseline and the count of hair at several control points relative to baseline, between the two dosage groups.

Additional effectiveness assessments included hair shedding counts during hair washing (shampooing) in subjects treated with the supplement containing 5,000 mcg of biotin per serving, compared with subjects treated with the supplement containing 10,000 mcg of biotin per serving, as well as changes in quality-of-life and self-assessment questionnaire scores during and after the study.

The tolerability of the studied supplement was assessed on the basis of the patient's subjective complaints, the presence and severity of adverse reactions/side effects, the data of the patient's examination, and laboratory examination.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv Oblast
    • Kyiv, Kyiv Oblast, Ukraine, 02002,
      • Limited Liability Company Treatment and Diagnostic Center ADONIS Plus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participants must meet all of the following criteria:

1. Adults aged 21-50 years.
2. Generally healthy, as determined by medical history, physical exam, and available laboratory results from Visit 1 (Day -1/Day 0).
3. Self-perceived thinning hair associated with diet, stress, or hormonal influences.
4. Willingness to maintain the usual hair care routine, including shampoo frequency, and consistent haircut/color during the study.
5. Willingness to take the study supplement daily as instructed.
6. Willingness to avoid major changes in diet, medications, or exercise during the study and to notify the clinic of any changes.
7. 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.
8. Fitzpatrick skin types I-IV.
9. Ability and willingness to provide written informed consent.

Exclusion Criteria:

Participants will be excluded if they meet any of the following:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low Dose 5,000 mcg Biotin Group	Dietary supplement: Complex with Biotin 5,000 mcg, Collagen, Keratin and Hyaluronic Acid.; Biotin, Collagen, and Keratin Beauty Complex 25,000 mcg, 60 capsules, oral route of administration. (Low Dose Biotin, 5,000 mcg per Serving)
Active Comparator: High Dose 10,000 mcg Biotin Group	Dietary supplement: Complex with Biotin 10,000 mcg, Collagen, Keratin and Hyaluronic Acid.; Biotin, Collagen, and Keratin Beauty Complex 30,000 mcg, 60 capsules, oral route of administration. (High Dose Biotin, 10,000 mcg per Serving)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Hair shedding, assessed by participant-recorded diary - subjects record the approximate number of hairs shed during hair washing over the study period. The diary is reviewed by the investigator at follow-up visits and at End of Study to assess changes over time.	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.	Quality of Life Questionnaire - assessment of how hair condition affects daily life and overall lifestyle. Maximum Score: 48 points; Minimum Score: 0 points. A lower score indicates a better outcome.	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.	Self-Assessment Questionnaire - participant evaluation of hair, nails, and skin qualities. Maximum Score: 48 points; Minimum Score: 0 points. A lower score indicates a better outcome.	End of Study (Visit 4, Day 90)

Collaborators and Investigators

• Sponsor: Nutra Harmony LLC

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Williamson D, Gonzalez M, Finlay AY. The effect of hair loss on quality of life. J Eur Acad Dermatol Venereol. 2001;15:137-139.
• Harrison S, Bergfeld W. Diffuse hair loss: its triggers and management. Cleveland Clin J Med. 2009;76(6):361-367.
• Finner AM. Nutrition and hair: deficiencies and supplements. Dermatol Clin. 2013;31:167-172.
• Patel DP, Swink SM, Castelo-Soccio L. Nutritional supplementation for hair loss: a systematic review. J Drugs Dermatol. 2017;16(12):1167-1172.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: women; oral supplement; hair thickness; hair strength; hair falling; hair thinning
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia; Amino Acids, Peptides, and Proteins; Proteins; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Carbohydrates; Imidazoles; Enzymes and Coenzymes; Polymers; Macromolecular Substances; Glycosaminoglycans; Polysaccharides; Coenzymes; Biopolymers; Extracellular Matrix Proteins; Scleroproteins; Cytoskeletal Proteins; Intermediate Filament Proteins; Hyaluronic Acid; Biotin; Collagen; Keratins
• Other Study ID Numbers: Nutra 2-1216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD (Individual Participant Data) will not be shared, as information about each participant is strictly confidential. Only aggregated information regarding the effectiveness and safety of the investigated supplement among all study participants will be shared within the framework of statistical data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No