Hair ThinningNCT06605768
Study Evaluating the Effects of Dietary Supplement on Hair Thickness and Hair Strength in Individuals With Self-Perceived Thinning Hair
A study testing Complex with Biotin, Collagen, Keratin, Hyaluronic Acid. in people with Hair Thinning, run by Nutra Harmony LLC at 1 site in Ukraine.
Trial 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. 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, Collagen, Keratin, Hyaluronic Acid.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUkraine
- Study dates
- 19 Feb 2024to 12 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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.
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- 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.
Who cannot join
- 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.
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- 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.).
Trial locations and contacts
1 site in 1 country.
Ukraine1 site
Limited Liability Company Treatment and Diagnostic Center ADONIS Plus
Kyiv
About this study
Official title: A 3-Month, Randomized, Single-Blind, Placebo-Controlled Study Evaluating the Ability of Nutra Harmony "Biotin, Collagen &Amp;Amp; Keratin Beauty Complex" Dietary Supplement Promotion in Hair Thickness and Hair Strength in Individuals With Self-Perceived Thinning Hair
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.
Read the detailed description
This study was a two-arm, parallel group, double-blind, placebo-controlled trial powered to detect meaningful differences in the hair growth for people suffering from temporary thinning hair between the treatment(main) and control groups at 3 months. Participants of the main group were prescribed the "Biotin, Collagen \& Keratin Beauty Complex" 30,000 mcg, 60 capsules produced by NUTRA HARMONY LLC, participants of the control group were prescribed placebo (microcrystalline cellulose (MCC)), 60 capsules manufactured by NUTRA HARMONY LLC. The duration of study in both groups of subjects was 3 months and the treatment period continued for 90 days following randomization. A total of 80 males and females aged 21 to 50 with temporary thinning hair who meet all eligibility criteria were randomized in this study. Within the study, there were a total of 6 site visits for each participant, during which the following procedures were performed:
Visit 1 (Screening visit):
Signing the informed consent document Demography recording Height, weight assessment Vital signs: pulse, systolic [SBP] and diastolic [DBP] blood pressure, after 10 minutes of resting position Medical history \& Current medications Hematology A urine pregnancy test (for women of childbearing potential Physical examination: general/appearance; head, eyes, ears, nose, throat, and oropharynx; skin evaluations; respiratory; cardiovascular; abdomen/gastrointestinal; urological system, musculoskeletal system and neurological system High-quality clinical and dermoscopic photographs of hair in the target area of the scalp made by dermatoscope High-quality photographs of hair in the target area of the scalp made by digital camera Quality of Life Questionnaire
Visit 2 (Randomization):
Vital signs: pulse, systolic [SBP] and diastolic [DBP] blood pressure, after 10 minutes of resting position Study Intervention randomization: participants will be assigned randomly in a 1:1 ratio to study product or placebo.
Visit 3 (Day 21), Visit 4 (Day 40), Visit 5 (Day 60):
Vital signs: pulse, systolic [SBP] and diastolic [DBP] blood pressure, after 10 minutes of resting position Counting the amount of hair that fell out with each wash Determining the change in hair area compared to the baseline Counting the amount of hair in several control points compared to the baseline
Visit 6 (Day 90, End of Study):
Vital signs: pulse, systolic [SBP] and diastolic [DBP] blood pressure, after 10 minutes of resting position Hematology Counting the amount of hair that fell out with each wash Determining the change in hair area compared to the baseline Counting the amount of hair in several control points compared to the baseline High-quality clinical and dermoscopic photographs of hair in the target area of the scalp made by dermatoscope High-quality photographs of hair in the target area of the scalp made by digital camera Quality of Life Questionnaire Self-assessment Questionnaire
The effectiveness of the treatment was evaluated by considering the increase in hair growth in study supplement-treated subjects, which was defined by determining the change in hair area from the baseline and counting the amount of hair in several control points from the baseline comparing to placebo-treated subjects, as well as hair washing (shampooing) for hair shedding counts in study supplement-treated subjects comparing to placebo-treated subjects and the change in patient quality of life questionnaires and self-assessment questionnaires during and following 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, Collagen, Keratin, Hyaluronic Acid., Placebo product
- 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, Collagen, Keratin, Hyaluronic Acid.Dietary supplement
Biotin, Collagen \& Keratin Beauty Complex" 30,000 mcg, 60 capsules, oral route of administration.
Placebo productDietary supplement
Placebo, 60 capsules, oral route of administration
| Study group | Role | What they receive |
|---|---|---|
| Group Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo product |
| Group Treatment | Active comparator | Not described Receives: Dietary Supplement: Complex with Biotin, Collagen, Keratin, Hyaluronic Acid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 90
Secondary outcomes (4)
Hair Thinning
Hair thinning was evaluated in the target scalp area using standardized trichoscopic assessment. The endpoint reflects the proportion of participants with visible hair shaft thinning/decreased hair caliber at the specified time point.
Measured: 90 Days
Increase in the Amount of Vellus Hair Compared to Mature Hairs
The vellus-to-terminal hair pattern was assessed by trichoscopy in the target scalp area. The endpoint reflects the proportion of participants with an increased proportion of vellus hairs compared with mature (terminal) hairs at the specified time point.
Measured: 90 Days
Increased Distance Between Units
Inter-unit spacing was assessed by trichoscopy in the target scalp area. The endpoint reflects the proportion of participants with an increased distance between follicular units, indicating reduced follicular density, at the specified time point.
Measured: 90 Days
Inflammatory Processes in the Scalp and Blood Vessels
Signs of inflammation were assessed by trichoscopic evaluation of the scalp and superficial vessels in the target area. The endpoint reflects the proportion of participants with trichoscopic signs consistent with inflammatory processes (scalp inflammation and/or vascular changes) at the specified time point.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start19 Feb 2024
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hair ThinningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutra Harmony LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605768
- Sponsor's protocol ID
- Nutra 1-0602
- Status last verified
- Feb 2026
- First submitted
- 11 Sep 2024
- Last updated
- 3 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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
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.
PubMed 11277343Williamson 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-Month, Randomized, Single-Blind, Placebo-Controlled Study Evaluating the Ability of Nutra Harmony "Biotin, Collagen &Amp;Amp; Keratin Beauty Complex" Dietary Supplement Promotion in Hair Thickness and Hair Strength in Individuals With Self-Perceived Thinning Hair
- ClinicalTrials.gov ID
- NCT06605768
- Acronym / sponsor ID
- Nutra 1-0602
- Conditions
- Hair Thinning
- Keywords
- Hair thinning, hair thickness, hair strength, hair falling, women, oral supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nutra Harmony LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 20 Sep 2024 (actual)
- Results
- Posted 3 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was a two-arm, parallel group, double-blind, placebo-controlled trial powered to detect meaningful differences in the hair growth for people suffering from temporary thinning hair between the treatment(main) and control groups at 3 months. Participants of the main group were prescribed the "Biotin, Collagen \& Keratin Beauty Complex" 30,000 mcg, 60 capsules produced by NUTRA HARMONY LLC, participants of the control group were prescribed placebo (microcrystalline cellulose (MCC)), 60 capsules manufactured by NUTRA HARMONY LLC. The duration of study in both groups of subjects was 3 months and the treatment period continued for 90 days following randomization. A total of 80 males and females aged 21 to 50 with temporary thinning hair who meet all eligibility criteria were randomized in this study. Within the study, there were a total of 6 site visits for each participant, during which the following procedures were performed:
Visit 1 (Screening visit):
Signing the informed consent document Demography recording Height, weight assessment Vital signs: pulse, systolic [SBP] and diastolic [DBP] blood pressure, after 10 minutes of resting position Medical history \& Current medications Hematology A urine pregnancy test (for women of childbearing potential Physical examination: general/appearance; head, eyes, ears, nose, throat, and oropharynx; skin evaluations; respiratory; cardiovascular; abdomen/gastrointestinal; urological system, musculoskeletal system and neurological system High-quality clinical and dermoscopic photographs of hair in the target area of the scalp made by dermatoscope High-quality photographs of hair in the target area of the scalp made by digital camera Quality of Life Questionnaire
Visit 2 (Randomization):
Vital signs: pulse, systolic [SBP] and diastolic [DBP] blood pressure, after 10 minutes of resting position Study Intervention randomization: participants will be assigned randomly in a 1:1 ratio to study product or placebo.
Visit 3 (Day 21), Visit 4 (Day 40), Visit 5 (Day 60):
Vital signs: pulse, systolic [SBP] and diastolic [DBP] blood pressure, after 10 minutes of resting position Counting the amount of hair that fell out with each wash Determining the change in hair area compared to the baseline Counting the amount of hair in several control points compared to the baseline
Visit 6 (Day 90, End of Study):
Vital signs: pulse, systolic [SBP] and diastolic [DBP] blood pressure, after 10 minutes of resting position Hematology Counting the amount of hair that fell out with each wash Determining the change in hair area compared to the baseline Counting the amount of hair in several control points compared to the baseline High-quality clinical and dermoscopic photographs of hair in the target area of the scalp made by dermatoscope High-quality photographs of hair in the target area of the scalp made by digital camera Quality of Life Questionnaire Self-assessment Questionnaire
The effectiveness of the treatment was evaluated by considering the increase in hair growth in study supplement-treated subjects, which was defined by determining the change in hair area from the baseline and counting the amount of hair in several control points from the baseline comparing to placebo-treated subjects, as well as hair washing (shampooing) for hair shedding counts in study supplement-treated subjects comparing to placebo-treated subjects and the change in patient quality of life questionnaires and self-assessment questionnaires during and following 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Placebo | Placebo comparator | Dietary Supplement: Placebo product |
| Group Treatment | Active comparator | Dietary Supplement: Complex with Biotin, Collagen, Keratin, Hyaluronic Acid. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex with Biotin, Collagen, Keratin, Hyaluronic Acid.Biotin, Collagen \& Keratin Beauty Complex" 30,000 mcg, 60 capsules, oral route of administration. | Dietary supplement | Group Treatment |
| Placebo productPlacebo, 60 capsules, oral route of administration | Dietary supplement | Group Placebo |
Primary outcome
Hair Shedding (1-2 Hairs Per Unit)
Time frame: Day 90
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.
4 secondary outcomes
Hair Thinning
Time frame: 90 Days
Increase in the Amount of Vellus Hair Compared to Mature Hairs
Time frame: 90 Days
Increased Distance Between Units
Time frame: 90 Days
Inflammatory Processes in the Scalp and Blood Vessels
Time frame: 90 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11277343Thom 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.
- Background: PubMed 11495520Williamson 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex with Biotin, Collagen, Keratin, 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 13 inclusion and 14 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: finished, as of the sponsor's last update on 3 Feb 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 3 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hair Shedding (1-2 Hairs Per Unit) (time frame: Day 90). 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 NCT06605768, which also lists 2 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 3 Feb 2026.