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Hair ThinningNCT07520019

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 study testing Complex with Biotin 5,000 mcg, Collagen, Keratin and Hyaluronic Acid. and Complex with Biotin 10,000 mcg, Collagen, Keratin and Hyaluronic Acid. in people with Hair Thinning, run by Nutra Harmony LLC at 1 site in Ukraine.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 50 years
Conditions the study is for
Hair Thinning
What is being tested?
Complex with Biotin 5,000 mcg, Collagen, Keratin and Hyaluronic Acid. and Complex with Biotin 10,000 mcg, Collagen, Keratin and Hyaluronic Acid.
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUkraine
Study dates
15 Jan 2026to 15 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

1 site in 1 country.

Ukraine1 site
  • Limited Liability Company Treatment and Diagnostic Center ADONIS Plus

    Kyiv, Kyiv Oblast, 02002,

Other trials in Ukraine

About this study

Official title: 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.

Read the 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.

Conditions
Hair Thinning
Being tested
Complex with Biotin 5,000 mcg, Collagen, Keratin and Hyaluronic Acid., Complex with Biotin 10,000 mcg, Collagen, Keratin and Hyaluronic Acid.
Keywords
hair thinning, hair thickness, hair strength, hair falling, women, oral supplement
Medical subject headings
Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

  • 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)

Study groups in NCT07520019
Study groupRoleWhat they receive
Low Dose 5,000 mcg Biotin GroupActive comparatorNot described
Receives: Dietary Supplement: Complex with Biotin 5,000 mcg, Collagen, Keratin and Hyaluronic Acid.
High Dose 10,000 mcg Biotin GroupActive comparatorNot described
Receives: Dietary Supplement: Complex with Biotin 10,000 mcg, Collagen, Keratin and Hyaluronic Acid.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  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 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.

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

Secondary outcomes (3)
  1. 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.

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

  2. 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.

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

  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.

    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.

    Measured: End of Study (Visit 4, Day 90)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start15 Jan 2026
  3. Primary completion1 May 2026 (estimated)
  4. Study completion15 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07520019
Sponsor's protocol ID
Nutra 2-1216
Status last verified
Apr 2026
First submitted
2 Apr 2026
Last updated
14 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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.

  • Glynis A. A Double-blind, Placebo-controlled Study Evaluating the Efficacy of an Oral Supplement in Women with Self-perceived Thinning Hair. J Clin Aesthet Dermatol. 2012 Nov;5(11):28-34.

    PubMed 23198010
  • 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.

    PubMed 11495520
  • Harrison S, Bergfeld W. Diffuse hair loss: its triggers and management. Cleve Clin J Med. 2009 Jun;76(6):361-7. doi: 10.3949/ccjm.76a.08080.

    PubMed 19487557
  • Finner AM. Nutrition and hair: deficiencies and supplements. Dermatol Clin. 2013 Jan;31(1):167-72. doi: 10.1016/j.det.2012.08.015. Epub 2012 Oct 18.

    PubMed 23159185
  • 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 Mar;9(1):51-70. doi: 10.1007/s13555-018-0278-6. Epub 2018 Dec 13.

    PubMed 30547302

Questions about this trial

What is this clinical trial studying?

A study testing Complex with Biotin 5,000 mcg, Collagen, Keratin and Hyaluronic Acid. and Complex with Biotin 10,000 mcg, Collagen, Keratin and Hyaluronic Acid. in people with Hair Thinning, run by Nutra Harmony LLC at 1 site in Ukraine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Baseline (Visit 1) and End of Study (Visit 4, Day 90)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07520019, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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