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
Phase: NA
Conditions: Hair Thinning
Sponsor: Nutra Harmony LLC

NUTRA HARMONY LLC 
Final Clinical Study Report 
 
A 3-Month, Randomized, Single-Blind, Placebo-Controlled Study Evaluating the 
Ability of Nutra Harmony “Biotin, Collagen & Keratin Beauty Complex” Dietary 
Supplement Promotion in Hair Thickness and Hair Strength in Individuals with 
Self-Perceived Thinning Hair 
 
 
 
PRINCIPAL INVESTIGATOR: Prof. Olga Gyrina, Limited Liability Company 
Treatment and Diagnostic Center ADONIS Plus, Outpatient Department, 8B, Raisy 
Okipnoi St., Kyiv 02002, Ukraine                                                                        
 
 
    DATE STUDY INITIATED:19 February 2024 
    (Date first subject signed informed consent) 
 
DATE STUDY COMPLETED: 12 July 2024 
    (Date when the last study-related procedure was performed) 
 
 
 
 
Date: 30 August 2024​
 
Prepared by: NUTRA HARMONY LLC 
 
 
GCP Compliance: This study was conducted in compliance with Good Clinical Practice. 
​
 
Confidentiality Statement 
The information in this document contains trade secrets and commercial information that are 
privileged or confidential and may not be disclosed unless such disclosure is required by 
applicable law or regulations. In any event, persons to whom the information is disclosed 
must be informed that the information is privileged or confidential and may not be further 
disclosed by them. These restrictions on disclosure will apply equally to all future 
information supplied to you that is indicated as privileged or confidential. 
 
 

 
 
TABLE OF CONTENTS 
TABLE OF CONTENTS 
2 
SIGNATURES PAGE 
4 
SYNOPSIS 
5 
RESUME 
6 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
7 
ETHICS 
8 
INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE 
9 
INTRODUCTION 
10 
OBJECTIVES 
10 
1.​
Primary Objective 
10 
2.​
Secondary Objectives 
10 
METHODS 
10 
1.​
Overview of Study Design 
10 
2.​
Procedures performed 
12 
STUDY POPULATION 
13 
1.​
Overview 
13 
2.​
Inclusion Criteria 
13 
3.​
Exclusion Criteria 
14 
4.​
Removal of Subjects from Therapy or Assessment 
15 
STUDY AGENT INFORMATION 
15 
1.​
Product packaging, storage and handling instructions 
17 
2.​
Randomization and Blinding 
17 
3.​
Dosage and Administration 
17 
4.​
Treatment Compliance 
17 
CONCOMITANT THERAPY 
18 
STUDY EVALUATIONS 
18 
1.​
Efficacy Evaluations 
18 
2.​
Safety Evaluations 
19 
3.​
Adverse Events 
19 
4.​
Pregnancy 
20 
5.​
Adverse Events Resulting in Removal of Subjects from Therapy or Assessment 
20 
6.​
Serious Adverse Events 
20 
QUALITY CONTROL AND DATA QUALITY ASSURANCE 
20 
STUDY DOCUMENTATION 
20 
CLINICAL STUDY MONITORING 
21 
 

 
STATISTICAL METHODS PLANNED IN THE CLINICAL STUDY PROTOCOL 
21 
1.​
Justification of Sample Size 
21 
2.​
Secondary Endpoints of the Study 
21 
3.​
Subject and information 
22 
3.1​
Subject Disposition and Study Completion/Withdrawal Information 
22 
3.2​
Discontinuation of Study Agent and Termination of Study Participation 
22 
3.3​
Distribution of Subjects 
22 
4.​
Null and Alternative Hypotheses 
28 
5.​
Analysis of Baseline Homogeneity of Groups 
29 
6.​
Analysis of Effectiveness in Each Group 
30 
7.​
Comparing Therapy Effectiveness Between Groups 
31 
8.​
Significance Levels 
31 
9.​
Conclusion on Therapeutic Action 
31 
10.​
Patients Included in the Analysis 
31 
11.​
Changes in the Conduct of the Planned Study or in the Planned Analysis 
32 
12.​
Medical History Data 
33 
CONCLUSIONS 
41 
REFERENCES 
42 
 
 

 
 
SIGNATURES PAGE 
 
Study Title 
A 3-Month, Randomized, Single-Blind, Placebo-Controlled 
Study Evaluating the Ability of Nutra Harmony “Biotin, 
Collagen & Keratin Beauty Complex” Dietary Supplement 
Promotion in Hair Thickness and Hair Strength in 
Individuals with Self-Perceived Thinning Hair 
Version of Protocol 
1.0 from 06 Feb 2024 
We, the undersigned, have read this final study report and hereby certify that the study was conducted 
in accordance with the requirements of the Protocol and the presented research results are true and 
reliable. 
 
Sponsor 
NUTRA HARMONY LLC 
 312 W 2nd St., Office 5161, Casper, WY 82601 
 +1 – 855 - 505 - 0012 
Sponsor’s responsible person 
 
​
 
_______________________  
 
Study Center 
Limited Liability Company Treatment and Diagnostic 
Center ADONIS Plus, Outpatient Department, 8B, Raisy 
Okipnoi St., Kyiv 02002, Ukraine                                             
Principal Investigator 
 
 
 
 
________________________ Prof. Olga Gyrina 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
SYNOPSIS 
 
Title: 
A 3-Month, Randomized, Single-Blind, Placebo-Controlled Study 
Evaluating the Ability of Nutra Harmony “Biotin, Collagen & Keratin 
Beauty Complex” Dietary Supplement Promotion in Hair Thickness 
and Hair Strength in Individuals with Self-Perceived Thinning Hair. 
Study Description: 
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 21-45 years of 
age with self-perceived thinning hair associated with poor diet, stress, 
hormonal influences when compared to using the placebo tablet. 
Objectives: 
 
The objective of this single-blind, placebo-controlled study is to assess 
the ability of Nutra Harmony “Biotin vitamins with collagen & 
keratin” to promote the growth of terminal hairs in adults with 
self-perceived thinning hair. 
Endpoints: 
The primary endpoints are to establish a significant increase in hair 
growth in study supplement-treated subjects which will be 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. 
The secondary endpoints of the study are determined by 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 following treatment. 
 
Study Population: 
Individuals, ages 21-50 years of age 
Phase: 
N/A 
Description of Study 
Intervention: 
“Biotin, Collagen & Keratin Beauty Complex” 30,000 mcg, 60 
capsules, oral route of administration. Placebo (microcrystalline 
cellulose (MCC)), 60 capsules, oral route of administration 
Study Duration: 
3 months 
 
 

 
 
    RESUME 
 
This report presents the materials of the clinical study “A 3-Month, Randomized, Single-Blind, 
Placebo-Controlled Study Evaluating the Ability of Nutra Harmony “Biotin, Collagen & Keratin 
Beauty Complex” Dietary Supplement Promotion in Hair Thickness and Hair Strength in Individuals 
with Self-Perceived Thinning Hair.” 
The clinical trial was conducted in order to assess the ability of the studied “Biotin, Collagen & 
Keratin Beauty Complex” 30,000 mcg, 60 capsules produced by NUTRA HARMONY LLC 
compared to placebo (microcrystalline cellulose (MCC)), 60 capsules manufactured by NUTRA 
HARMONY LLC.  
The clinical study was conducted on the basis of the outpatient department of Adonis Plus Medical 
Diagnostic Center LLC. 80 patients with self-perceived thinning hair were included as study subjects. 
Based on the method of simple randomization, patients were divided into the main group - 40 
patients and the control group - 40 patients in a ratio of 1:1. Patients of the main group were 
prescribed the “Biotin, Collagen & Keratin Beauty Complex” 30,000 mcg, 60 capsules produced by 
NUTRA HARMONY LLC, patients 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 (90 days). 
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 hair 
examination and laboratory examination. 
According to the results of the study, the supplement was found to be effective for subjects who were 
receiving “Biotin, Collagen & Keratin Beauty Complex” 30,000 mcg, 60 capsules produced by 
NUTRA HARMONY LLC, compared to placebo (microcrystalline cellulose (MCC)), 60 capsules 
manufactured by NUTRA HARMONY LLC 
The study supplement “Biotin, Collagen & Keratin Beauty Complex” 30,000 mcg, 60 capsules 
produced by NUTRA HARMONY LLC was well tolerated by study participants and did not cause 
serious adverse reactions. The study supplement was well tolerated by participants.  
 
The report contains: 37 pages, 16 tables and 8 sources of domestic and foreign literature. 
 

 
 LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
AE 
Adverse Event 
CONSORT 
Consolidated Standards of Reporting Trials 
EC 
Ethics Committee 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
ICH 
International Conference on Harmonization  
IRB 
Institutional Review Board 
PI 
Principal Investigator 
SAE 
Serious Adverse Event 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 

 
ETHICS 
 
Independent Ethics Committee/Institutional Review Board 
The study protocol and amendments were reviewed by a Local Ethics Committee of Limited 
Liability Company Treatment and Diagnostic Center ADONIS Plus, Outpatient Department. 
 
Ethical Conduct of the Study 
This study was conducted in accordance with the ethical principles of the Declaration of 
Helsinki, the Law of Ukraine "On Medicinal Products", orders of the Ministry of Health of 
Ukraine No. 95 and 690, in compliance with the principles of Good Clinical Practice (GCP) and 
in strict accordance with the Study Protocol. Known instances of nonconformance were 
documented and are not considered to have had an impact on the overall conclusions of this 
study. 
 
Subject Information and Consent 
Subjects provided their written consent to participate in the study after having been informed 
about the nature and purpose of the study, participation/termination conditions, and risks and 
benefits of treatment. Known instances of nonconformance were documented and are not 
considered to have impacted the overall conclusions of this study. 
Subjects were informed that in case of violation of their rights during clinical research, they can 
apply to the Local Ethics Committee. 
The principal investigator (PI) and the Sponsor ensured the protection of personal data of the 
subjects participating in the study. Personal data from subjects enrolled in this study were limited 
to those data necessary to investigate the efficacy, safety, quality, and utility of the investigational 
study agent(s) used in this study and were collected and processed with adequate precautions to 
ensure confidentiality and compliance with applicable data privacy protection laws and 
regulations.  
 
 

 
 
 
INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE 
 
Principal Investigator:                          Prof. Olga Gyrina                                                                                          
 
    Study Center: ​
                            Limited Liability Company Treatment  
                                                                and Diagnostic Center ADONIS Plus,  
                                                                Outpatient Department, 8B, Raisy Okipnoi St.,  
                                                                   Kyiv 02002, Ukraine             
                                                            
    Sponsor:                                               NUTRA HARMONY LLC 
                                            312 W 2nd St., Office 5161, Casper, WY 82601 
                                                                 +1 – 855 - 505 - 0012 
 
Sponsor's Responsible: 
    Local Ethics Committee:                      Local Ethics Committee of Limited Liability 
                                                                  Company Treatment and Diagnostic Center   
                                                                  ADONIS Plus, Outpatient Department,  
                                                                    8B, Raisy Okipnoi St., Kyiv 02002, Ukraine                                             
                                           
  
 

 
INTRODUCTION 
     
Hair loss in women and men is often an overlooked and underappreciated condition. Reasons for 
pattern hair loss include medical conditions, medications, and physiologic or emotional stress. But 
one of the most common causes may surprise you: nutrition. Nutritional deficiencies may include 
inadequate intake of proteins, minerals, essential fatty acids, and vitamins. So, a nutritional 
intervention may be beneficial for patients with hair loss. Recent evidence suggested that the used 
of nutritional supplementation among patients with hair loss disorders is prevalent.  
The study supplement “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 purpose of this single-blind, placebo-controlled study was to evaluate the ability of study 
supplement to strengthen and promote the growth of terminal hairs in adults with self-perceived 
thinning hair associated with poor diet, stress, hormonal influences after using it for 3 months, 
compared to placebo. 
 
OBJECTIVES 
The objectives of this study were: 
 
1.​ Primary Objective 
 
To evaluate the efficacy of supplement capsules compared to placebo in adults with self-perceived 
thinning hair 
 
2.​ Secondary Objectives 
 
To evaluate the effect of supplement capsules on the following clinical parameters in participants 
with self-perceived thinning hair: 
o​ the amount of hair that fell out with each wash; 
o​ the change in hair area compared to the starting point; 
o​ the amount of hair in several control points compared to the starting point 
 
METHODS 
 
1.​ Overview of Study Design 
 
Overall Design 
 
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 
10 
 

 
between the treatment and control arms at 3 months. Total trial duration for participants 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. 
A schematic representation of the study design is presented in Schedule of Activities (SoA) 
scheme: 
 
 
Time of Assessment 
 
Visit 1 
(Screening) 
Visit 2 
(Randomization) 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
(End of Study) 
Day 0 
Day 1 
Day 21 
Day 40 
Day 60 
Day 90 
Eligibility 
✔ 
 
 
 
 
 
Informed Consent 
✔ 
 
 
 
 
 
Demographics 
✔ 
 
 
 
 
 
Vital Signs (HR, BP) 
✔ 
✔ 
✔ 
✔ 
✔ 
✔ 
Height, weight 
assessment 
✔ 
 
 
 
 
 
Medical History & 
Current Medications 
✔ 
 
 
 
 
 
Hematology 
✔ 
 
 
 
 
✔ 
Urine pregnancy test 
✔ 
 
 
 
 
 
Complete Physical 
Examination 
✔ 
 
 
 
 
✔ 
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 
✔ 
 
 
 
 
✔ 
Study Intervention 
randomization 
 
✔ 
 
 
 
 
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 
 
 
✔ 
✔ 
✔ 
✔ 
11 
 

 
baseline 
Quality of Life 
Questionnaire 
✔ 
 
 
 
 
✔ 
Self-assessment 
Questionnaire 
 
 
 
 
 
✔ 
Some of the scheduled visit days were shifted for objective reasons by prior agreement with the 
sub-investigator. 
 
2.​ Procedures performed: 
 
Visit 1 (Screening visit) 
A screening visit was carried out in order to identify eligible consenting subjects for the study. 
Participants were randomized on the same day as Screening. After the completion of the screening 
assessments, eligible participants were randomized. 
The following procedures were taking place: 
●​ 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)  
Patients were considered randomized once all eligibility criteria were confirmed. Randomization 
visit was performed on the same day as Screening. 
The following procedures were taking place: 
●​ 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) 
The following procedures were taking place: 
12 
 

 
●​ 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) 
The following procedures were taking place: 
●​ 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 
 
 
STUDY POPULATION 
 
1.​ Overview 
 
A total of 80 males and females aged 21 to 50 with temporary thinning hair who met all eligibility 
criteria were randomized in this study. 
 
2.​ Inclusion Criteria 
Subjects had to satisfy all of the following criteria to be enrolled in the study: 
1.​ Individuals, ages 21-50 years of age. 
2.​ Clinically-determined general good health as determined by responses to the initial study 
assessment. 
3.​ Individuals with self-perceived thinning hair associated with poor diet, stress, hormone 
influences. 
4.​ Individuals willing to maintain their normal hair shampooing frequency. 
5.​ Individuals willing to add the provided oral supplement to their current daily routine. 
6.​ 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. 
13 
 

 
7.​ Individuals willing to undergo a physical exam to include height, weight, blood pressure, 
pulse, general physical findings, scalp exam and blood sample collection.  
8.​ Individuals with Fitzpatrick I-IV photo skin types. 
9.​ Willingness to have digital photography of the target area and scalp for hair counts at Visits 
1, 2, 3, 4, 5, 6. 
10.​Willingness to have their hair washed (shampooed) over a sink containing cheesecloth for 
hair shedding counts at Visit 1, 2, 3, 4, 5, 6. 
11.​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. 
12.​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). 
13.​Provision of signed and dated informed consent form. 
3.​ Exclusion Criteria 
Subjects were not to be enrolled into the study if they: 
1.​ Individuals with a known history of intolerance or allergy to fish, seafood/shellfish or 
acerola. 
2.​ Individuals with any known allergy or sensitivity to any shampoo/conditioner. 
3.​ Females who are nursing, pregnant, planning to become pregnant during the study. 
4.​ Individuals with known stressful incident within the last six months (i.e. death in family, 
miscarriage). 
5.​ Individuals who are participating on any clinical research study at another research center or 
doctor's office. 
6.​ 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. 
7.​ Individuals currently using light therapy to treat thinning hair. 
8.​ Individuals who have regularly used Rogaine (Minoxidil) within the last 3 months. 
9.​ Individuals currently using any other biotin/keratin/collagen supplements. 
10.​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). 
11.​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. 
14 
 

 
12.​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. 
13.​Individuals with self-reported active hepatitis, immune deficiency, HIV or autoimmune 
disease. 
14.​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.). 
4.​ Removal of Subjects from Therapy or Assessment 
 
Administration of study product to a subject was discontinued and the subject was withdrawn from 
the study if any of the following occurred: 
●​ Pregnancy. 
●​ Significant study intervention non-compliance.  
●​ If any clinical adverse event (AE), laboratory abnormality, or other medical condition or 
situation occurs such that continued participation in the study would not be in the best 
interest of the participant. 
●​ If the participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation. 
●​ Participant unable (because of health or personal issues) to receive study intervention (study 
supplement or placebo). 
 
The reason for the participant's discontinuation or withdrawal from the study should have been 
recorded in the subject's research documentation for that trial. 
An early termination visit was conducted at the time of withdrawal from the study, according to the 
Assessment Schedule. The subject permanently discontinued participation in both the study drug 
intervention and the study at that time. Participants could withdraw from the study at any time upon 
request. 
 
STUDY AGENT INFORMATION 
 
The interventions for this study were study supplement capsules and a comparator (placebo). All 
investigational products were manufactured by NUTRA HARMONY LLC under the brand name 
“Biotin, Collagen & Keratin Beauty Complex”. Details for the study drug and placebo are shown in 
Table 1. 
 
 
 
 
Table 1 “Details for Study Drug” 
15 
 

 
 
Preparations to be Administered 
Study Drug 
Placebo 
Study Drug Name 
Biotin, Collagen & Keratin Beauty 
Complex 
Microcrystalline cellulose (MCC) 
Manufacturer 
NUTRA HARMONY LLC 
NUTRA HARMONY LLC 
Sourcing 
Provided by the sponsor 
Provided by the sponsor 
Packaging 
and Labeling 
Will be provided in capsule bottle with 
black cap within a carton. Each carton 
and vial will be labeled accordingly. 
Will be provided in capsule bottle with 
black cap within a carton. Each carton 
and vial will be labeled accordingly. 
Formulation 
Biotin, Collagen & Keratin Beauty 
Complex 30,000 mcg:  
Vitamin A 1,200 mcg RAE (4,000 IU), 
Vitamin D3 3 mcg (120 IU), 
Thiamin(vitamin B1) 5 mg, 
Riboflavin(vitamin B2) 5mg, 
Niacin(vitamin B3) 5 mg, Vitamin B6 5 
mg, Folate 340 mcg DFE(200 mcg folic 
acid), Vitamin B12 20 mcg, Biotin 
10,000 mcg, Pantothenic Acid 50 mg, 
Calcium 80 mg, Phosphorus 40 mg, 
Proprietary blend 710 mg (Fish 
Collagen, 
Methylsulfonylmethane(MSM), 
Hydrolyzed Keratin, Bamboo Extract 
(Bambusa vulgaris) (stem & leaf) (std. 
to 70% silica), Coconut Oil (Cocos 
nucifera), Nettle Extract (Urtica dioica) 
(root), Grape Seed Extract (Vitis 
vinifera)), Other ingredients: Organic 
Rice Flour, Cellulose (Vegetable 
Capsule) 
 Microcrystalline cellulose (MCC) 
Dosage Form 
Capsule 
Capsule 
Container/Closure 
60-count capsule bottle with black cap 
and safety seal around the cap within a 
carton 
60-count capsule bottle with black cap 
and safety seal around the cap within a 
carton 
Route of 
Administratio
n 
Oral 
Oral 
Dose and Frequency 2 capsules daily 
2 capsules daily 
 
 
 
 
 
1.​ Product packaging, storage and handling instructions 
16 
 

 
 
Study product and placebo had been supplied both in similar capsule bottle with black cap within a 
carton. Each carton and vial had been labeled accordingly. Prepared doses of study product and 
placebo had been labeled by study site staff. 
Study product had been stored in a secure, environmentally controlled (cool, dry place below 85°F 
(29°C) protected from light and heat) and monitored area with access limited to authorized site 
staff. 
 
Placebo (microcrystalline cellulose) had been stored and handled at the study site under the same 
conditions as the study product (in a cool, dry place below 85°F (29°C), protected from light and 
heat). 
 
2.​ Randomization and Blinding 
 
Randomization of the intervention took place locally. There were 2 intervention groups of the 
study. Participants were randomly assigned 1:1 to study product or placebo. 
This was a single-blind study; therefore, the Sponsor and Investigators were aware of the 
interventions, but the participants were blinded. 
 
3.​ Dosage and Administration 
 
At the second randomization visit, participants received one of the following 90-day doses of the 
study drug (until the last visit, visit 6): 
• group 1: “Biotin, Collagen & Keratin Beauty Complex” 30,000 mcg, 60 capsules 
• group 2: placebo (looks like “Biotin, Collagen & Keratin Beauty Complex” 30,000 mcg, 60 
capsules, but contains no active substance) 
 
Starting from visit 2 and until visit 6, regardless of the study drug prescribed, study participants 
took: 1 capsule of “Biotin, Collagen & Keratin Beauty Complex” or a placebo corresponding to 
“Biotin, Collagen & Keratin Beauty Complex”, twice a day. 
 
4.​ Treatment Compliance 
 
When participants/caregivers performed the study intervention on site, compliance with the study 
intervention was assessed by on-site staff observation. The date and time of each dose administered 
in the clinic was recorded in the source documents. If participants/caregivers completed the study 
intervention at home, adherence to the study intervention was assessed at the next visit on site. A 
record of the number of pre-filled bottles dispensed and returned to each participant was maintained 
and reconciled with study intervention records and site compliance by qualified site staff. 
 
 
 
17 
 

 
CONCOMITANT THERAPY 
 
For this protocol, a prescription medication was defined as a medication that can be prescribed only 
by a properly authorized/licensed clinician. Medications which were reported in the primary 
documentation are concomitant prescription medications, over-the-counter medications and 
supplements. 
 
STUDY EVALUATIONS 
 
1.​ Efficacy Evaluations 
 
Descriptive statistics were obtained for all variables. Normality checks of continuous measurements 
were performed and data were checked for homogeneity of variance. Changes in baseline hair 
growth, amount of hair shedding during hair washing, quality-of-life responses, and self-report 
questionnaire responses were examined using repeated-measures analysis of variance. Endpoint 
parameters measured at each assessment were compared with baseline data using a paired t-test. 
Comparisons between active treatment and placebo were performed using analysis of variance 
(ANOVA). 
 
●​ Counting the Number of Hairs Lost During Each Wash 
The study participant washed their hair at home 24 hours before each visit to the research center. 
During the visit to the research center, the participant washed their hair at the center. To collect the 
hair lost during washing, a piece of cloth or gauze was placed over the sink. The number of hairs 
collected in the gauze was counted and recorded in individual forms. 
 
●​ Determination of Hair Area Change Compared to the Starting Point 
Measurements of the scalp area were taken, and phototrichograms of the selected target area were 
made using a dermatoscope. Using macrophotographs, the researcher determined the change in hair 
area in the target region of the scalp. 
 
●​ Counting the Number of Hairs at Several Control Points Compared to the Starting 
Number 
Phototrichograms of vellus and terminal hairs at selected target control points were performed 
using a dermatoscope. Macrophotographs were analyzed by a trichologist, and the number of 
terminal and vellus hairs at the selected target control points was determined for each participant. 
 
●​ Filling Out Questionnaires 
During the study, patients completed questionnaires at the research center. One questionnaire 
assessed the overall quality and how hair thinning affected their life. The other questionnaire 
focused on evaluating parameters related to hair, nails, and skin. 
 
18 
 

 
●​ Comparing Effectiveness Between Groups 
When comparing effectiveness between groups, a non-parametric relationship was found, which 
requires consideration of dispersion for proper analysis. The aim of this study is to obtain 
information about the effectiveness of the "Biotin, Collagen & Keratin Beauty Complex" (60 
capsules), developed by NUTRA HARMONY LLC, in promoting hair growth and reducing hair 
loss in individuals who believe their hair is thinning, compared to a placebo. 
Efficacy assessments were performed according to the Schedule of Activities (SoA) in the protocol 
and described in section 1.3 of the protocol. 
Data for these performance variables were recorded in the primary documentation. Some efficacy 
data, such as high-quality clinical and dermoscopic hair photographs, were collected and stored in 
electronic file format. 
 
2.​ Safety Evaluations 
Safety and tolerability were assessed, comparing study supplement to placebo, by clinical review of 
all relevant parameters including AEs, clinical laboratory test (hematology) and vital signs. The 
primary approach to analysis of safety were including all data through 90 days on treatment. AEs 
were coded using the standard MedDRA. 
Descriptive statistics for vital signs were presented by randomization group and time point 
assessed. Descriptive statistics for the change from baseline to each post-baseline time point for the 
vital sign parameters were summarized by randomization group. 
 
With the exception of clinical laboratory data, the data for these safety variables were recorded in 
the primary documentation. All clinical laboratory tests were analyzed by a local laboratory and a 
study site personnel. The clinical laboratory data were collected and recorded in the primary 
documentation. The timing of all safety procedures was described in the the Schedule of Activities 
(SoA) in the protocol which located in section 1.3 of the protocol. 
 
3.​ Adverse Events 
Adverse events were either reported by the subject voluntarily or were obtained by means of 
interviewing subjects in a nondirected manner at study visits. Adverse event definitions, 
attributions, and severity criteria are listed in the protocol. 
 
All AEs were described and recorded on the subject's source document including date of onset, 
seriousness, severity, outcome and action taken, and relationship as evaluated by the investigator.  
In the event of a serious adverse event (SAE) or unexpected AE, the study sponsor was notified 
as specified in the protocol.  
 
Adverse events of interest were: hematologic laboratory abnormalities, hypersensitivity reactions. 
 
19 
 

 
4.​ Pregnancy 
No pregnancies were reported during the study. 
 
5.​ Adverse Events Resulting in Removal of Subjects from Therapy or Assessment 
Adverse events were reported for one subject from group 1: study supplement and one subject from 
group 2: placebo. Both subjects discontinued study assessment. 
 
6.​ Serious Adverse Events 
No SAE were reported during the study. 
 
QUALITY CONTROL AND DATA QUALITY ASSURANCE 
 
The Investigator had the education, professional training and experience that allowed to take 
responsibility for the proper conduct of the clinical trial. The qualification of the Investigator met 
the regulatory requirements and was confirmed by his scientific biography (curriculum vitae) and 
other documents that were provided to the Sponsor before the start of the study. 
The Primary Investigator kept a list of persons with the necessary qualifications who, on his behalf, 
carried out certain activities within the framework of the study. 
STUDY DOCUMENTATION 
Before the start of the study, the investigator provided the Sponsor with the following documents: 
●​ Signed contract between the research center and the Sponsor for conducting the clinical 
study; 
●​ License of the healthcare facility for medical practice; 
●​ Accreditation certificate of the healthcare facility; 
●​ List of research team members with assigned responsibilities; 
●​ Scientific biographies (CVs) of all research team members; 
●​ Certificates of investigators for completing GCP training (if available); 
●​ Order for the establishment of the Ethics Committee at the healthcare facility; 
●​ Composition of the Ethics Committee at the healthcare facility; 
●​ Document from the Ethics Committee at the healthcare facility approving the protocol and 
other materials of the clinical trial; 
●​ Normal values/normal ranges for clinical/laboratory/instrumental tests/researches provided 
in the clinical trial protocol; 
●​ Documents confirming certification or accreditation, or internal and/or external quality 
control of laboratory equipment, and other verification methods. 
Before the start of the study, the Sponsor provided the research center with the following 
documents: 
20 
 

 
●​ Act of transfer of the investigational products; 
●​ Current version of the clinical study protocol; 
●​ Individual patient registration forms (in the required quantity); 
●​ Informed consent forms and patient information forms (in the required quantity); 
●​ Instructions for the medical use of the drug; 
●​ Copy of the insurance certificate; 
●​ Certificate of quality of the investigational/reference drug; 
CLINICAL STUDY MONITORING 
The monitoring of the clinical study was conducted by the Sponsor. Monitoring of the research 
center was carried out through site visits, telephone contacts, and regular review of CRFs at a 
frequency sufficient to assess patient recruitment rates, adherence to the study protocol, 
completeness and accuracy of the data entered into the CRFs, and the occurrence of Adverse 
Events (AEs) / Adverse Reactions (ARs). 
The investigator provided the Sponsor representatives with the opportunity to: 
●​ Visit the research center, access the area where the study is conducted, and review study 
materials; 
●​ Meet with members of the research team and access the study documentation; 
●​ Verify the accuracy of CRF completion and reconcile CRFs with primary medical 
documentation; 
All information related to study monitoring is considered strictly confidential. 
 
STATISTICAL METHODS PLANNED IN THE CLINICAL STUDY PROTOCOL 
1.​ Justification of Sample Size 
The sample size is assessed based on the primary variable of the trial and depends on its type. This 
trial is a simple, blind, randomized, placebo-controlled study. 
Primary variables include the increase in hair growth in subjects who received the study 
supplement, noted by determining the change in hair area compared to the baseline and counting 
the number of hairs at several control points compared to patients who received a placebo after 90 
days of supplement intake. 
2.​ Secondary Endpoints of the Study 
Secondary endpoints were determined using microscopic photographs to measure the hair growth 
area after washing to count the number of hairs lost in subjects who received the study supplement 
compared to those who received a placebo, and changes in patient self-assessment based on 
21 
 

 
questionnaires after treatment. 
 
3.​ Subject and information 
 
3.1​Subject Disposition and Study Completion/Withdrawal Information 
In this study 80 subjects were enrolled. Consent was obtained from the first subject on 19 
February 2024. The last study-related procedure was performed on 12 July 2024. 
3.2​Discontinuation of Study Agent and Termination of Study Participation 
Of the 80 subjects who entered the study, 2 subjects discontinued study supplement/placebo due 
to an AE and one subject discontinued study agent due to loss of follow-up. Seventy-seven 
subjects completed the final visit. 
3.3​Distribution of Subjects 
Normally, approximately 90% of all hair is in the anagen phase (growth), 3% (rest) is in the catagen 
phase, and 7% (stop and shedding) is in the telogen phase. According to the protocol requirements, 
patients were included in comparative groups based on age: 21-30 years, 31-40 years, and 41-50 
years, both in the placebo group and in the dietary supplement group. The symptoms presented by 
patients were predominantly categorized into the following groups: thinning, weakening, 
inflammatory processes in the scalp and blood vessels, skin flaking, increased oiliness, and an 
increase in the amount of vellus hair compared to mature hair. Only a small percentage of 
volunteers who took the placebo did not exhibit these processes and could be considered 
conditionally healthy. The data are presented in Table 2 for women and Table 3 for men. 
 
22 
 

 
 
Table 2. Distribution of participants by the nature of scalp and hair symptoms in women at 
baseline 
Symptoms of the disease 
Dietary supplement 
Placebo 
21-30 
years 
31-40 
years 
41-50 
years 
21-30 
years 
31-40 
years 
41-50 
years 
Hair shedding (1-2 hairs 
per unit) 
5 
9 
10 
5 
7 
6 
Hair thinning 
2 
7 
6 
6 
4 
5 
Inflammatory processes 
in the scalp and blood 
vessels 
3 
7 
4 
6 
4 
6 
Increased distance 
between units 
2 
3 
7 
2 
2 
4 
Increase in the amount of 
vellus hair compared to 
mature hairs 
2 
3 
5 
3 
5 
0 
 
Table 3. Distribution of participants by the nature of scalp and hair symptoms in men at 
baseline 
Symptoms of the disease 
Dietary supplement 
Placebo 
21-30 
years 
31-40 
years 
41-50 
years 
21-30 
years 
31-40 
years 
41-50 
years 
Hair shedding (1-2 hairs 
per unit) 
2 
1 
0 
4 
1 
1 
Hair thinning 
2 
1 
0 
5 
0 
0 
Inflammatory processes 
in the scalp and blood 
vessels 
1 
0 
0 
5 
1 
1 
Increased distance 
between units 
1 
1 
0 
3 
1 
1 
Increase in the amount of 
vellus hair compared to 
mature hairs 
​
1 
0 
0 
1 
1 
0 
 
After analysis, we understand that the differences in the frequency of symptom occurrence between 
women and men are statistically insignificant. 
Table 4. Distribution of participants by the nature of scalp and hair symptoms in women one 
month after starting treatment 
 
Symptoms of the disease 
Dietary supplement 
Placebo 
21-30 
years 
31-40 
years 
41-50 
years 
21-30 
years 
31-40 
years 
41-50 
years 
23 
 

 
Hair shedding (1-2 hairs 
per unit) 
4 
8 
8 
5 
7 
6 
Hair thinning 
2 
6 
6 
6 
4 
5 
Inflammatory processes 
in the scalp and blood 
vessels 
3 
6 
4 
5 
4 
6 
Increased distance 
between units 
2 
3 
6 
2 
2 
4 
Increase in the amount of 
vellus hair compared to 
mature hairs 
​
3 
4 
6 
3 
5 
0 
 
Table 5. Distribution of participants by the nature of scalp and hair symptoms in women 
three months after starting treatment 
Symptoms of the disease 
Dietary supplement 
Placebo 
21-30 
years 
31-40 
years 
41-50 
years 
21-30 
years 
31-40 
years 
41-50 
years 
Hair shedding (1-2 hairs 
per unit) 
2 
4 
3 
4 
6 
6 
Hair thinning 
1 
3 
2 
5 
4 
4 
Inflammatory processes 
in the scalp and blood 
vessels 
1 
2 
3 
5 
3 
6 
Increased distance 
between units 
1 
1 
2 
1 
2 
4 
Increase in the amount of 
vellus hair compared to 
mature hairs 
​
6 
7 
8 
3 
5 
1 
 
Table 6. Distribution of participants by the nature of scalp and hair symptoms in men three 
months after starting treatment 
Symptoms of the disease 
Dietary supplement 
Placebo 
21-30 
years 
31-40 
years 
41-50 
years 
21-30 
years 
31-40 
years 
41-50 
years 
Hair shedding (1-2 hairs 
per unit) 
1 
0 
0 
3 
1 
1 
Hair thinning 
0 
1 
0 
4 
0 
0 
Inflammatory processes 
in the scalp and blood 
vessels 
0 
0 
0 
4 
1 
1 
Increased distance 
between units 
0 
1 
0 
3 
1 
1 
24 
 

 
Increase in the amount of 
vellus hair compared to 
mature hairs 
​
2 
1 
0 
1 
1 
0 
 
Table 7. Distribution of participants in percentage terms by the nature of hair problem 
manifestations at baseline relative to the total number of individuals in each study group 
(women) 
Symptoms of the disease 
Dietary supplement 
Placebo 
21-30 
years, % 
31-40 
years, 
% 
41-50 
years, 
% 
21-30 
years, % 
31-40 
years, % 
41-50 
years, 
% 
Hair shedding (1-2 hairs 
per unit) 
71,43 
60,00 
67,78 
62,50 
77,78 
46,15 
Hair thinning 
28,57 
46,67 
40,00 
75,00 
44,44 
38,46 
Inflammatory processes 
in the scalp and blood 
vessels 
42,86 
46,67 
26,67 
75,00 
44,44 
46,15 
Increased distance 
between units 
28,57 
20,00 
46,67 
25,00 
22,22 
30,78 
Increase in the amount of 
vellus hair compared to 
mature hairs 
​
28,57 
20,00 
33,33 
37,50 
55,56 
0 
 
Table 8. Distribution of participants in percentage terms by the nature of hair problem 
manifestations at one month of the study relative to the total number of individuals in each 
study group (women) 
Symptoms of the disease 
Dietary supplement 
Placebo 
21-30 
years, % 
31-40 
years, 
% 
41-50 
years, 
% 
21-30 
years, % 
31-40 
years, % 
41-50 
years, 
% 
Hair shedding (1-2 hairs 
per unit) 
57,14 
53,33 
53,33 
62,50 
77,78 
46,15 
Hair thinning 
28,57 
40,00 
40,00 
75,00 
44,44 
38,46 
Inflammatory processes 
in the scalp and blood 
vessels 
42,86 
40,00 
26,67 
62,50 
44,44 
46,15 
Increased distance 
between units 
28,57 
20,00 
40,00 
25,00 
22,22 
30,78 
Increase in the amount of 
vellus hair compared to 
mature hairs 
42,85 
26,67 
40,00 
37,50 
55,56 
0 
25 
 

 
Table 9. Distribution of participants in percentage terms by the nature of hair problem 
manifestations at three months of the study relative to the total number of individuals in each 
study group (women) 
Symptoms of the disease 
Dietary supplement 
Placebo 
21-30 
years, % 
31-40 
years, 
% 
41-50 
years, 
% 
21-30 
years, % 
31-40 
years, % 
41-50 
years, 
% 
Hair shedding (1-2 hairs 
per unit) 
28,57 
26,67 
20,00 
50,00 
66,67 
46,15 
Hair thinning 
14,29 
20,00 
13,33 
62,50 
44,44 
30,77 
Inflammatory processes 
in the scalp and blood 
vessels 
14,29 
13,33 
20,00 
62,50 
33,33 
46,15 
Increased distance 
between units 
14,29 
6,67 
13,33 
12,50 
22,22 
30,78 
Increase in the amount of 
vellus hair compared to 
mature hairs 
85,71 
46,67 
53,33 
37,50 
55,56 
7,69 
Compared to baseline, the hair area increased due to the activation of the anagen phase and the 
extension of the catagen phase. 
As seen from the tables, the amount of vellus (young) hair in women increased 3.64 times in the 
age group of 20 to 30 years, 2.33 times in the age group of 31 to 40 years, and 1.6 times in the age 
group of 41 to 50 years after three months of taking the dietary supplement, compared to baseline. 
In contrast, for the placebo group, changes were as follows: no changes were observed in the 
20-30-year age group, no changes were noted in the 31-40-year age group, and in the 41-50-year 
age group, changes in the amount of hair in the anagen phase were noted in a few women, who also 
reported improvements in digestive processes, which could be a reason for these changes. 
Analyzing hair thinning in the groups of volunteers who took the dietary supplement, the situation 
improved twofold for women in the 20-30-year age group, based on the number of participants who 
reported hair thinning at the three-month mark compared to baseline. 
In the 31-40-year age group, the situation improved 2.33 times, and in the 41-50-year age group, 
the situation improved threefold compared to baseline. 
For the placebo group, the situation in the youngest group improved by 20%, in the 31-40-year 
group the situation did not change after three months, and in the older age group, the situation 
improved by 33.7%, which is most likely related to the normalization of digestive processes for 
these participants. 
26 
 

 
 
Table 10. Distribution of participants in percentage terms by the nature of hair problem 
manifestations at baseline relative to the total number of individuals in each study group 
(men) 
Symptoms of the 
disease 
Dietary supplement 
Placebo 
21-30 
years, % 
31-40 
years, % 
41-50 
years, 
% 
21-30 
years, % 
31-40 
years, % 
41-50 
years, % 
Hair shedding (1-2 hairs 
per unit) 
100,00% 
100,00
% 
0 
80,00% 
100,00% 
100,00
% 
Hair thinning 
100,00% 
100,00
% 
0 
100,00% 
0 
100,00
% 
Inflammatory processes 
in the scalp and blood 
vessels 
50,00% 
0 
0 
100,00% 
100,00% 
100,00
% 
Increased distance 
between units 
50,00% 
100% 
0 
60,00% 
100,00% 
100,00
% 
Increase in the amount 
of vellus hair compared 
to mature hairs 
50,00% 
0 
0 
20,00% 
100,00% 
0 
Table 11. Distribution of participants in percentage terms by the nature of hair problem 
manifestations at three months of the study relative to the total number of individuals in each 
study group (men) 
Symptoms of the 
disease 
Dietary supplement 
Placebo 
21-30 
years, % 
31-40 
years, % 
41-50 
years, 
% 
21-30 
years, % 
31-40 
years, % 
41-50 
years, % 
Hair shedding (1-2 hairs 
per unit) 
50,00% 
0 
0 
60,00% 
100,00% 
100,00
% 
Hair thinning 
0 
100,00
% 
0 
80,00% 
0 
100,00
% 
Inflammatory processes 
in the scalp and blood 
vessels 
0 
0 
0 
80,00% 
0 
100,00
% 
Increased distance 
between units 
0 
0 
0 
100,00% 
100,00% 
100,00
% 
Increase in the amount 
of vellus hair compared 
to mature hairs 
200,00% 
100% 
0 
0 
0 
0 
27 
 

 
Compared to baseline, the hair area increased due to the activation of the anagen phase and the 
extension of the catagen phase. 
As seen from the tables, the amount of vellus (young) hair in men increased fourfold in the age 
group of 20 to 30 years and twofold in the age group of 31 to 40 years after three months of taking 
the dietary supplement, compared to baseline. There was no group for men aged 41 to 50. 
In the placebo group, there was no increase in hair area for men; that is, the hair growth area did not 
change, and the number of hairs per measurement point also remained at baseline levels. 
4.​ Null and Alternative Hypotheses 
For this trial, where the primary variable is dichotomous, let PSUP and PPL represent the proportion 
of "positive results" (category: "no improvement in hair condition and no change in hair area at 90 
days after the start of treatment") when comparing different age groups and genders between the 
dietary supplement and the corresponding placebo groups. The null hypothesis is formulated as 
follows: 
H0: ⎸ PSUP−PPL ⎹ ≥δ, 
and the alternative hypothesis, Ha, will be: 
Ha: ⎸PSUP−PPL⎹<δ, 
where δ represents the magnitude of clinically significant differences. 
Since evaluating the sample size should also consider that conclusions about the pharmaceutical 
effectiveness of the dietary supplement compared to the placebo (as an ineffective clinical product) 
should be based on a confidence interval approach. 
Based on the above, the size of the primary group, assuming patients are distributed into groups in 
a 1:1 ratio, can be estimated using the following statement: 
 
where 
-  p  is the size of the positive effect of the dietary supplement (in our case, PSUP), estimated from 
previous studies (measured as a percentage), assuming that the effect size of the investigated 
product will be the same; 
-  a  is the maximum probability of making a Type I error (significance level or the probability of 
28 
 

 
accepting the null hypothesis); 
- b  is the maximum probability of making a Type II error; 
- 
 and  
 are the corresponding upper percentiles of the standard normal distribution; 
- d is the maximum acceptable magnitude of clinically significant differences, where the 
investigated product is considered equivalent to the comparison product if the differences in 
effectiveness between the compared products do not exceed this value. 
Based on standard practice and regulatory requirements [2, 3], the following parameter values are 
typically used for such trials:  a = 0,05 (two-tailed);  b = 0,2  (which provides 80% statistical 
power). According to literature, experience, and results from previous clinical studies of 
dimethindene products, the maximum positive effect size of the reference product is on average 
95%. 
The magnitude of clinically significant differences d, according to [2], should be determined based 
on clinical judgment and be statistically justified. Since d essentially represents that the difference 
in the magnitude of the positive effect (in this case, the difference in proportions) along with 
confidence intervals should fall within the therapeutic equivalence range (from –d to +d), for this 
study, the magnitude of clinically significant differences was taken as 16% (d=16%). 
Substituting the initial data into the above formula for sample size estimation, the calculated 
number of patients in each group should be: 
 
Based on prior experience and results from earlier studies of generic versions of this product, it is 
known that up to 5% of patients may drop out from such a trial. Therefore, to ensure the required 
80% power of the study, each group needs to be increased by 5%, which raises the number of 
patients in each group to 40. 
5.​ Analysis of Baseline Homogeneity of Groups 
Conduct an analysis of group homogeneity based on clinical-demographic indicators and efficacy 
indicators. To do this: 
a) Use descriptive statistics to describe the baseline state of the primary and control groups. For 
quantitative indicators, report: sample size (n), mean, median, standard deviation, minimum and 
maximum values; for qualitative indicators, report: frequency and percentage. 
b) For quantitative indicators, check the normality of data distribution in the groups using the 
29 
 

 
Shapiro-Wilk test. If the data in the groups for specific indicators are normally distributed, compare 
the groups using the Student's t-test for independent samples (after checking the homogeneity of 
variances in the groups using Levene's test to choose the appropriate version of the Student's t-test). 
Otherwise (if data are not normally distributed), perform group comparisons using the 
Mann-Whitney U test. 
c) To make statistical conclusions about the baseline homogeneity of the groups based on the 
specified variables 
6.​ Analysis of Effectiveness in Each Group 
Determine the effectiveness of the therapy in the dietary supplement group compared to the placebo 
group using the following variables: 
●​ Data on the number of hairs lost at each stage in each group 
●​ Data on hair condition and control points 
●​ Data on patient-reported subjective complaints at the start and end of the study 
●​ Overall comparative effectiveness of the placebo and dietary supplement 
a) Clinical Indicators Expressed on a Rating Scale: 
●​ Report descriptive statistics for visits T1, T3, and T4 in each group (n, mean, median, 
standard deviation, minimum, and maximum values). 
●​ Calculate the relative change for each indicator in each group at subsequent visits compared 
to the baseline using the formula: 
 
Where n – visit 3, visit 4. 
Assess the trend of changes in the mean values of these indicators graphically by 
constructing the relevant graphs. 
●​ To evaluate the dynamics of this parameter in the groups, perform a two-way ANOVA in 
each group based on a mixed model (dependent variable — parameter; factors: "time" — 
fixed (levels: T1, T3, T4) and "patients" — random). 
b) Categorical Indicators: 
●​ Report descriptive statistics for categorical indicators at T1, T3, and T4 in each group 
(frequency and percentage). 
●​ Present their graphical dynamics. 
30 
 

 
 
 
 
7.​ Comparing Therapy Effectiveness Between Groups 
a) Comparing Effectiveness in Groups: 
●​ Compare the effectiveness between groups for the studied indicators by calculating 
dT1=(Visit 3−Visit 1) and dT4=(Visit 4−Visit 1)   
●​ If the groups are statistically non-significant at the first visit for a specific indicator, test the 
normality of the distribution of dT3 and dT4 in each group using the Shapiro-Wilk test. 
Compare the groups for these parameters using the Student's t-test for independent samples 
or the Mann-Whitney U test, depending on the results of the normality test. 
●​ If the groups are statistically significant at the first visit for a specific indicator, perform a 
covariance analysis for dT of the given indicator using the following model: 
o​ Dependent variable: the analyzed indicator 
o​ Factor "group" - fixed (levels: primary, control) 
o​ Covariate - value of the indicator at the first visit. 
●​ Check the normality of the residuals from the covariance analysis using the Shapiro-Wilk 
test. If the residuals are not normally distributed, perform a rank-based analysis. 
8.​ Significance Levels 
●​ The significance level for the Shapiro-Wilk test should be set at 0.01, while for other tests, it 
should be set at 0.05. 
9.​ Conclusion on Therapeutic Action 
●​ The conclusion regarding the equivalence of the two studied products, the dietary 
supplement and placebo, based on efficacy indicators, will use a confidence interval 
approach. To do this: 
o​ Calculate the 95% confidence interval boundaries for the difference in proportions 
of positive results between the experimental and control groups. 
o​ Compare these boundaries with the equivalence zone limits (16%; ±16%). 
o​ If the lower limit of the confidence interval is greater than the lower limit of the 
equivalence zone and the upper limit of the confidence interval is less than the upper 
limit of the equivalence zone, then the investigated product will be considered 
equivalent to the comparison product in terms of efficacy. 
10.​Patients Included in the Analysis 
31 
 

 
●​ The effectiveness analysis will include patients who completed a 90-day course of the 
dietary supplement or placebo. Volunteers who have violated the requirements of this 
protocol (inclusion/exclusion criteria, treatment regimen, prescription of non-recommended 
concomitant therapy, etc.), as well as patients who dropped out of the study due to adverse 
reactions, will not be included in the effectiveness analysis. 
11.​Changes in the Conduct of the Planned Study or in the Planned Analysis 
●​ No changes have been made to the study plan or data analysis. 
Table 12: Distribution of Volunteers by Gender 
Gender 
Dietary 
Supplement 
Placebo 
Total 
n 
% 
n 
% 
N 
% 
Men 
3 
7,5 
7 
18,9 
10 
12,98 
Women 
37 
92,5 
30 
81,08 
67 
87,01 
Total 
40 
100 
37 
100 
77 
100 
 
To assess the homogeneity of groups by gender, the Pearson chi-square test with continuity 
correction is typically used. In our case, the analysis indicates that gender does not have a 
significant impact on the results. Therefore, despite the non-homogeneous distribution by gender, it 
can be concluded that, according to the results from the use of the supplement and placebo, there 
are no significant differences in the effects on hair growth, its condition, or thinning based on 
gender. 
Table 13: Distribution of Volunteers by Age in the Dietary Supplement Group 
Gender 
21-30 years 
31-40 years 
41-50 years 
n 
% 
N 
% 
n 
% 
Men 
2 
22,2 
1 
6,25 
0 
0 
Women 
7 
77,8 
15 
93,75 
15 
100 
Total 
9 
100 
16 
100 
15 
100 
Table 14: Distribution of Volunteers by Age in the Placebo Group 
Gender 
21-30 years 
31-40 years 
41-50 years 
32 
 

 
n 
% 
N 
% 
n 
% 
Men 
5 
38,46 
1 
10 
1 
7,14 
Women 
8 
61,54 
9 
90 
13 
92,86 
Total 
13 
100 
10 
100 
14 
100 
12.​Medical History Data 
Trichoscopic examination was conducted using the Aramo-SG trichoscope (AramoSG® Skin & 
Hair Diagnosis System, Korea) with subsequent image analysis (macro-, ×20-, ×60-fold 
magnification) and assessment of the primary trichoscopic criteria for hair disorders. 
Normally, approximately 90% of all hair is in the anagen phase (growth), 3% (rest) is in the catagen 
phase, and 7% (cessation and shedding) is in the telogen phase. 
According to the protocol requirements, patients were included in the study in comparative groups 
of 21-30 years, 31-40 years, and 41-50 years for both the placebo group and the dietary supplement 
group. Symptoms predominantly observed in patients were grouped as follows: thinning, reduction 
in hair thickness, inflammatory processes in the scalp and blood vessels, scaling of the skin, 
increased oiliness, and an increase in the number of vellus hairs compared to terminal hairs. Only a 
small percentage of volunteers receiving placebo did not exhibit these processes and could be 
considered conditionally healthy. Data are presented in Table 15 for women and Table 16 for men. 
Table 15: Distribution of Female Participants by Type of Scalp and Hair Symptomatology 
Symptoms of 
the disease 
Dietary supplement 
Placebo 
21-30 
years 
31-40 
years 
41-50 
years 
21-30 
years 
31-40 
years 
41-50 
years 
Hair thinning 
(1-2 hairs per 
unit) or 
increasing the 
distance 
between units 
3 
8 
6 
6 
7 
9 
Hair thinning 
4 
7 
3 
6 
4 
11 
Inflammatory 
processes in the 
scalp and blood 
vessels 
3 
7 
4 
6 
4 
6 
Skin peeling 
1 
3 
6 
2 
5 
6 
Disruption of 
1 
0 
0 
2 
0 
1 
33 
 

 
sebum 
regulation 
Increased 
number of 
vellus hairs 
compared to 
terminal hairs 
or one hair per 
unit 
2 
3 
5 
3 
5 
0 
Table 16: Distribution of Male Participants by Type of Scalp and Hair Symptomatology 
Symptoms of 
the disease 
Dietary supplement 
Placebo 
21-30 
years 
31-40 
years 
41-50 
years 
21-30 
years 
31-40 
years 
41-50 
years 
Hair thinning 
(1-2 hairs per 
unit) or 
increasing the 
distance 
between units 
1 
1 
0 
4 
1 
1 
Hair thinning 
0 
1 
0 
5 
0 
0 
Inflammatory 
processes in the 
scalp and blood 
vessels 
1 
0 
0 
0 
1 
0 
Skin peeling 
1 
1 
0 
0 
0 
0 
Disruption of 
sebum 
regulation 
0 
1 
0 
1 
1 
0 
Increased 
number of 
vellus hairs 
compared to 
terminal hairs 
or one hair per 
unit 
0 
0 
0 
0 
1 
0 
After analysis, we understand that the differences in the frequency of symptom occurrence between 
women and men are statistically insignificant. 
Upon analyzing the tabular data, it becomes clear that: 
34 
 

 
A. For women of all age groups, the intake of dietary supplements led to an overall 
improvement: 
In the group of women aged 21 to 30: 
1.​ Women aged 21 to 30 saw an improvement after one month of taking the supplement, with 
hair loss reduced by 32.35%. 
2.​ Women aged 21 to 30 saw an improvement after two months of taking the supplement, with 
hair loss reduced by 4.35% compared to the first month, and a total reduction of 32.29% 
compared to baseline. 
3.​ Women aged 21 to 30 saw an improvement after three months of taking the supplement, 
with hair loss reduced by 54.55% compared to the second month, and a total reduction of 
70.59% compared to baseline. 
In the group of women aged 31 to 40: 
1.​ Women aged 31 to 40 saw an improvement after one month of taking the supplement, with 
hair loss reduced by 20%. 
2.​ Women aged 31 to 40 saw an improvement after two months of taking the supplement, with 
hair loss reduced by 20.83% compared to the first month, and a total reduction of 36.67% 
compared to baseline. 
3.​ Women aged 31 to 40 saw an improvement after three months of taking the supplement, 
with hair loss reduced by 47.37% compared to the second month, and a total reduction of 
66.67% compared to baseline. 
In the group of women aged 41 to 50: 
1.​ Women aged 41 to 50 saw an improvement after one month of taking the supplement, with 
hair loss reduced by 31.43%. 
2.​ Women aged 41 to 50 saw an improvement after two months of taking the supplement, with 
hair loss reduced by 12.5% compared to the first month, and a total reduction of 40% 
compared to baseline. 
3.​ Women aged 41 to 50 saw an improvement after three months of taking the supplement, 
with hair loss reduced by 33.33% compared to the second month, and a total reduction of 
60% compared to baseline. 
B. For women of all age groups, the intake of placebo led to the following overall situation: 
In the group of women aged 21 to 30: 
1.​ Women aged 21 to 30 saw an improvement after one month of taking the placebo, with hair 
loss reduced by 28%. 
35 
 

 
2.​ Women aged 21 to 30 had no change after two months of taking the placebo, with hair loss 
remaining the same on average (0% change) compared to the first month, and a total 
reduction of 28% compared to baseline. No progress was observed between the first and 
second months. 
3.​ Women aged 21 to 30 saw an improvement after three months of taking the placebo, with 
hair loss reduced by 16.67% compared to the second month, and a total reduction of 40% 
compared to baseline. 
In the group of women aged 31 to 40: 
1.​ Women aged 31 to 40 saw an improvement after one month of taking the placebo, with hair 
loss reduced by 7.5%. 
2.​ Women aged 31 to 40 saw an improvement after two months of taking the placebo, with 
hair loss reduced by 2.7% compared to the first month, and a total reduction of 10% 
compared to baseline. 
3.​ Women aged 31 to 40 saw an improvement after three months of taking the placebo, with 
hair loss reduced by 19.4% compared to the second month, and a total reduction of 26.47% 
compared to baseline. 
In the group of women aged 41 to 50: 
1.​ Women aged 41 to 50 saw an improvement after one month of taking the placebo, with hair 
loss reduced by 23.53%. 
2.​ Women aged 41 to 50 had no change after two months of taking the placebo, with hair loss 
remaining the same compared to the first month, and a total reduction of 23.53% compared 
to baseline. 
3.​ Women aged 41 to 50 saw an improvement after three months of taking the placebo, with 
hair loss reduced by 3.85% compared to the second month, and a total reduction of 26.47% 
compared to baseline. 
C. For women of all age groups, the intake of dietary supplements compared to placebo 
affected the change in hair loss as follows: 
In the group of women aged 21 to 30: 
1.​ After one month of taking the supplement, women aged 21 to 30 saw an improvement, with 
hair loss reduced by 32.35% compared to a 28% reduction with placebo. 
2.​ After two months of taking the supplement, women aged 21 to 30 saw an improvement, 
with hair loss reduced by 4.35% compared to a 0% change with placebo, and a total 
reduction of 32.29% compared to baseline with the supplement versus 28% with placebo. 
3.​ After three months of taking the supplement, women aged 21 to 30 saw an improvement, 
with hair loss reduced by 54.55% compared to a 16.67% reduction with placebo, and a total 
reduction of 70.59% compared to baseline with the supplement versus 40% with placebo. 
36 
 

 
In the group of women aged 21 to 30, during the three months of taking the supplements, 
statistically significant improvement was observed, specifically: 
1.​ At the end of the first month, the difference between the dietary supplement and placebo 
was 13.45%. 
2.​ At the end of the second month, the difference between the dietary supplement and placebo 
was 43.5%, as no changes were observed with placebo on average. Compared to baseline, 
the reduction was 26.9%. 
3.​ At the end of the third month, the difference between the dietary supplement and placebo 
was 69.44%. Compared to baseline, the reduction was 43.33%. 
In the group of women aged 31 to 40: 
1.​ After one month of taking the supplement, women aged 31 to 40 saw an improvement, with 
hair loss reduced by 20% compared to a 7.5% reduction with placebo. 
2.​ After two months of taking the supplement, women aged 31 to 40 saw an improvement, 
with hair loss reduced by 20.83% compared to a 2.7% reduction with placebo from the first 
month. The total reduction compared to baseline was 36.67% with the supplement versus 
10% with placebo. 
3.​ After three months of taking the supplement, women aged 31 to 40 saw an improvement, 
with hair loss reduced by 47.37% compared to a 19.4% reduction with placebo from the 
second month. The total reduction compared to baseline was 66.67% with the supplement 
versus 26.47% with placebo. 
In the group of women aged 31 to 40, statistically significant improvement was observed over 
the three months of taking the supplements, specifically: 
1.​ At the end of the first month, the difference between the dietary supplement and placebo 
was 62.5%. 
2.​ At the end of the second month, the difference between the dietary supplement and placebo 
was 87%, as no average change was observed with placebo. Compared to baseline, the 
reduction was 72.73% with the supplement. 
3.​ At the end of the third month, the difference between the dietary supplement and placebo 
was 59%. Compared to baseline, the reduction was 60.3% with the supplement. 
In the group of women aged 41 to 50: 
1.​ After one month of taking the supplement, women aged 41 to 50 saw an improvement, with 
hair loss reduced by 31.43% compared to a 23.53% reduction with placebo. 
2.​ After two months of taking the supplement, women aged 41 to 50 saw an improvement, 
with hair loss reduced by 12.5%, while no change was observed in the placebo group 
compared to the first month. The total reduction compared to baseline was 40% with the 
supplement versus 23.52% with placebo. 
37 
 

 
3.​ After three months of taking the supplement, women aged 41 to 50 saw an improvement, 
with hair loss reduced by 33.33% compared to a 3.85% reduction with placebo from the 
second month. The total reduction compared to baseline was 60% with the supplement 
versus 26.47% with placebo. 
In the group of women aged 41 to 50, statistically significant improvement was observed over 
the three months of taking the supplements, specifically: 
1.​ At the end of the first month, the difference between the dietary supplement and placebo 
was 25.13%. 
2.​ At the end of the second month, the difference between the dietary supplement and placebo 
was 125%, as no average change was observed with placebo. Compared to baseline, the 
reduction was 41.2% with the supplement. 
3.​ At the end of the third month, the difference between the dietary supplement and placebo 
was 88.45%. Compared to baseline, the reduction was 55.88% with the supplement. 
 
38 
 

 
39 
 
Arithmetic mean values of variables for the active ingredient supplement among 41 volunteers according 
to randomization, with 1 screener excluded. 
Gender 
Total 
number 
Age 
Am
ount 
1 
2 
1 
2 
3 
4 
 
 
 
 
Avera
ge 
questi
onnair
e 
score 
at the 
visit 1 
Averag
e 
questio
nnaire 
score at 
the 
final 
visit 
Amount 
of hair 
lost during 
each wash 
(at 
baseline) 
Amount 
of hair 
lost during 
each wash 
(after 1 
month) 
Amount 
of hair 
lost during 
each wash 
(after 2 
months) 
Amount 
of hair 
lost 
during 
each 
wash 
(after 3 
months) 
F 
37 
21-3
0 
7 
23 
8 
34 
23 
22 
10 
 
 
31-4
0 
15 
21 
5 
30 
24 
19 
10 
 
 
41-5
0 
15 
24 
9 
35 
24 
21 
14 
 
 
 
 
 
 
 
 
 
 
M 
3 
21-3
0 
2 
5 
0 
18 
13 
 
12 
 
 
31-4
0 
1 
11 
6 
30 
25 
20 
15 
 
 
41-5
0 
0 
0 
0 
0 
0 
0 
0 
Arithmetic mean values of variables for placebo among 42 volunteers according to randomization, with 5 
screeners excluded 
Gender 
Total 
number 
Age 
Am
ount 
1 
2 
1 
2 
3 
4 
 
 
 
 
Avera
ge 
questi
onnair
e 
score 
at the 
visit 1 
Averag
e 
questio
nnaire 
score at 
the 
final 
visit 
Amount 
of hair 
lost during 
each wash 
(at 
baseline) 
Amount 
of hair 
lost during 
each wash 
(after 1 
month) 
Amount 
of hair 
lost during 
each wash 
(after 2 
months) 
Amount 
of hair 
lost 
during 
each 
wash 
(after 3 
months) 
F 
30 
21-3
0 
8 
29 
5 
50 
36 
36 
30 
 
 
31-4
0 
9 
23 
39 
40 
37 
36 
29 
 
 
41-5
0 
13 
19 
34 
34 
26 
26 
25 
 
 
 
 
 
 
 
 
 
 
M 
7 
21-3
0 
5 
16 
6 
19 
21 
21 
15 
 
 
31-4
1 
1 
0 
10 
20 
10 
16 

 
 
For men of all age groups, the intake of dietary supplements led to an overall improvement 
compared to placebo, starting from the second month of treatment. 
Calculations will be included in the report, as the trend across age groups remains consistent. 
 
40 
 
0 
 
 
41-5
0 
1 
11 
10 
15 
30 
30 
35 

 
CONCLUSIONS 
1. The supplement “Biotin, Collagen & Keratin Beauty Complex” manufactured by NUTRA 
HARMONY LLC is an effective supplement for individuals with self-perceived thinning hair. The 
action of the supplement involves reducing the severity of the clinical manifestations of hair-loss 
and the intensity of subjective complaints from the study participants. 
2. According to the study results, the course of the dietary supplement “Biotin, Collagen & Keratin 
Beauty Complex” manufactured by NUTRA HARMONY LLC was found to be effective compared 
to placebo after comparison in two separate groups. 
3. Based on the data from the conducted study, the hypothesis is confirmed that taking the "Beauty 
Complex with Biotin, Collagen, and Keratin" manufactured by NUTRA HARMONY LLC for 
more than three months strengthens and stimulates the growth of terminal hair in individuals aged 
21-50 with hair thinning related to poor nutrition, stress, and hormonal influences, compared to 
taking a placebo. 
4. The supplement “Biotin, Collagen & Keratin Beauty Complex” manufactured by NUTRA 
HARMONY LLC was well tolerated by subjects, did not cause serious adverse reactions, negative 
changes in objective examination data, or laboratory indicators.  
5. The supplement “Biotin, Collagen & Keratin Beauty Complex” manufactured by NUTRA 
HARMONY LLC is an effective and safe dietary supplement and can be recommended as a 
supplement for promotion of hair thickness and hair strength in individuals with self-perceived 
thinning hair. 
 
 
 
 
 
​
 
 
41 
 

 
 
 
 
REFERENCES 
 
1.​ Clinical study protocol “A 3-Month, Randomized, Single-Blind, Placebo-Controlled Study 
Evaluating the Ability of Nutra Harmony “Biotin, Collagen & Keratin Beauty Complex” 
Dietary Supplement Promotion in Hair Thickness and Hair Strength in Individuals with 
Self-Perceived Thinning Hair” Version 1.0 from 06 February 2024. 
2.​ Williamson D, Gonzalez M, Finlay AY. The effect of hair loss on quality of life. J Eur Acad 
Dermatol Venereol. 2001; 15:137–139. 
3.​ Thom E. Efficacy and tolerability of Hairgain in individuals with hair loss: a 
placebo-controlled, double-blind study. J Int Med Res. 2001; 29:2–6. 
4.​ S. Harrison and W. Bergfeld, “Diffuse hair loss: its triggers and management,” Cleveland 
Clinic Journal of Medicine, vol. 76, no. 6, pp. 361–367, 2009.  
5.​ M. Finner, “Nutrition and hair: deficiencies and supplements,” Dermatologic Clinics, vol. 
31, pp. 167–172, 2013. 
6.​ G. Ablon, “Double-blind, placebo-controlled study evaluating the efficacy of an oral 
supplement in women with self-perceived thinning hair,” Journal of Clinical and Aesthetic 
Dermatology, vol. 5, no. 11, pp. 28–34, 2012. 
7.​ Journal of Clinical and Aesthetic Dermatology “A Double-blind, Placebo-controlled Study 
Evaluating the Efficacy of an Oral Supplement in Women with Self-perceived Thinning 
Hair” November 2012 
8.​ Regina C. Windsor, MPH, RDN “Benefits and Side Effects of Biotin Supplements Touted 
as a Way to Stimulate Hair Growth and Treat Various Conditions” November 25, 2023 
 
42