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: 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Biotin, Collagen, and Keratin Beauty Complex 25,000 mcg, 60 capsules, oral route of administration. (Low Dose Biotin, 5,000 mcg per Serving)
Biotin, Collagen, and Keratin Beauty Complex 30,000 mcg, 60 capsules, oral route of administration. (High Dose Biotin, 10,000 mcg per Serving)
Limited Liability Company Treatment and Diagnostic Center ADONIS Plus
Kyiv, Kyiv Oblast, Ukraine
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.
Time frame: 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.
Time frame: Baseline (Visit 1) 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: End of Study (Visit 4, Day 90)
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