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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.
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:
Visit 2: (Day 30±3), Visit 3: (Day 60±3)
The following procedures will take place:
Visit 4: (Day 90, End of Study)
The following procedures will take place:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose 5,000 mcg Biotin Group | Active Comparator |
| |
| High Dose 10,000 mcg Biotin Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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 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) |
| 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. |
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Inclusion Criteria:
Participants must meet all of the following criteria:
Exclusion Criteria:
Participants will be excluded if they meet any of the following:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Limited Liability Company Treatment and Diagnostic Center ADONIS Plus | Kyiv | Kyiv Oblast | 02002, | Ukraine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 23198010 | Background | 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. | |
| 11495520 |
| Label | URL |
|---|---|
| Related Info | View source |
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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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| 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) |
|
| 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) |
| 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. |
| 19487557 | Background | 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. |
| 23159185 | Background | 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. |
| Background | Patel DP, Swink SM, Castelo-Soccio L. Nutritional supplementation for hair loss: a systematic review. J Drugs Dermatol. 2017;16(12):1167-1172. |
| 30547302 | Background | 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. |
| 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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