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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Placebo | Placebo Comparator |
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| Group Treatment | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complex with Biotin, Collagen, Keratin, Hyaluronic Acid. | Dietary Supplement | Biotin, Collagen & Keratin Beauty Complex" 30,000 mcg, 60 capsules, oral route of administration. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 Days |
| Increase in the Amount of Vellus Hair Compared to Mature Hairs |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Limited Liability Company Treatment and Diagnostic Center ADONIS Plus | Kyiv | Ukraine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11277343 | Background | 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. | |
| 11495520 | 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. |
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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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None. After completion of screening assessments, eligible participants were randomized and assigned to supplement or placebo on the same day (no washout or run-in period).
Participants were enrolled at a single outpatient research center (ADONIS Plus, Kyiv, Ukraine). Enrollment began on 19 Feb 2024 (first informed consent). Participants attended a site screening visit and, if eligible, were randomized and assigned to supplement or placebo. Study procedures continued through 12 Jul 2024 (last study procedure).
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| ID | Title | Description |
|---|---|---|
| FG000 | Group Placebo | Participants received matching placebo capsules containing microcrystalline cellulose (MCC). Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90). |
| FG001 | Group Treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2024 |
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| Placebo product | Dietary Supplement | Placebo, 60 capsules, oral route of administration |
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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. |
| 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. | 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. | 90 Days |
Participants received the investigational product "Biotin, Collagen & Keratin Beauty Complex" oral capsules. Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90).
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Baseline characteristics are reported for participants included in the baseline summary table (Treatment n=40; Placebo n=37).
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| ID | Title | Description |
|---|---|---|
| BG000 | Group Placebo | Participants received matching placebo capsules containing microcrystalline cellulose (MCC). Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90). |
| BG001 | Group Treatment | Participants received the investigational product "Biotin, Collagen & Keratin Beauty Complex" oral capsules. Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age categories at baseline (years). | Count of Participants | Participants |
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| Sex: Female, Male | Sex at baseline. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Hair Shedding (1-2 hair per unit) | Hair shedding at baseline was assessed by trichoscopic examination as the presence of 1-2 shed hairs per follicular unit (hair unit) in the examined scalp area. Results are reported as the number of participants meeting this criterion at baseline in each study group. | Count of Participants | Participants |
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| Hair thinning | Hair thinning at baseline was evaluated clinically and/or by trichoscopy as visible reduction in hair shaft caliber and/or overall decreased hair density in the examined scalp area. Results are reported as the number of participants with hair thinning present at baseline in each study group. | Count of Participants | Participants |
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| Increase in the amount of vellus hair compared to mature hairs | At baseline, the proportion of vellus hairs relative to mature (terminal) hairs was assessed by trichoscopy in the examined scalp area. An increased amount of vellus hair compared with mature hairs was recorded when vellus hairs predominated relative to mature hairs. Results are reported as the number of participants meeting this criterion at baseline in each study group. | Count of Participants | Participants |
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| Increased distance between units | Increased distance between follicular units at baseline was assessed by trichoscopy as widened spacing between hair units in the examined scalp area, consistent with reduced hair density. Results are reported as the number of participants with increased inter-unit distance present at baseline in each study group. | Count of Participants | Participants |
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| Inflammatory processes in the scalp and blood vessels | Signs of inflammatory processes in the scalp and scalp blood vessels at baseline were assessed by clinical examination and/or trichoscopy (e.g., erythema, perifollicular inflammation, and/or vascular/inflammatory changes). Results are reported as the number of participants with inflammatory findings present at baseline in each study group. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Day 90 |
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| Secondary | 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. | Posted | Count of Participants | Participants | 90 Days |
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| Secondary | 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. | Posted | Count of Participants | Participants | 90 Days |
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| Secondary | 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. | Posted | Count of Participants | Participants | 90 Days |
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| Secondary | 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. | Posted | Count of Participants | Participants | 90 Days |
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"From first dose (Day 1) through end of follow-up (Day 90)."
Adverse events were collected throughout the study period (Day 1-Day 90) via participant reporting and assessment at study visits. Events were recorded by study staff; allergic reactions were monitored due to product ingredients (fish and nuts).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group Placebo | Participants received matching placebo capsules containing microcrystalline cellulose (MCC). Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90). | 0 | 40 | 0 | 40 | 1 | 40 |
| EG001 | Group Treatment | Participants received the investigational product "Biotin, Collagen & Keratin Beauty Complex" oral capsules. Dosing: 1 capsule orally twice daily for 90 days (from Visit 2/Day 1 through Visit 6/Day 90). | 0 | 40 | 0 | 40 | 1 | 40 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Food allergy / allergic reaction | Immune system disorders | Systematic Assessment | Suspected food allergy/allergic reaction - led to discontinuation. |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Olga Gyrina | Limited Liability Company Treatment and Diagnostic Center ADONIS Plus, Outpatient Department | +19702136830 | info@adonis-international.com |
| Jan 14, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001710 | Biotin |
| D003094 | Collagen |
| D007633 | Keratins |
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007381 | Intermediate Filament Proteins |
| D003598 | Cytoskeletal Proteins |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| 31-40 |
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| 41-50 |
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