Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605768
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Study Evaluating the Effects of Dietary Supplement on Hair Thickness and Hair Strength in Individuals with Self-Perceived Thinning Hair
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A 3-Month Randomized Single-Blind Placebo-Controlled Study Evaluating the Ability of Nutra Harmony Biotin Collagen ampamp Keratin Beauty Complex Dietary Supplement Promotion in Hair Thickness and Hair Strength in Individuals with Self-Perceived Thinning Hair
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Nutra Harmony Biotin Collagen amp Keratin Beauty Complex is an oral fooddietary 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 amp Keratin Beauty Complex for over a three 3 month period will strengthen the hair and increase hair thickness by promoting the growth of terminal hairs in subjects ages 21-50 years of age with self-perceived thinning hair associated with poor diet stress hormonal influences when compared to using the placebo tablet
Detailed Description:
This study was a two-arm parallel group double-blind placebo-controlled trial powered to detect meaningful differences in the hair growth for people suffering from temporary thinning hair between the treatmentmain and control groups at 3 months Participants of the main group were prescribed the Biotin Collagen amp Keratin Beauty Complex 30000 mcg 60 capsules produced by NUTRA HARMONY LLC participants of the control group were prescribed placebo microcrystalline cellulose MCC 60 capsules manufactured by NUTRA HARMONY LLC The duration of study in both groups of subjects was 3 months and the treatment period continued for 90 days following randomization A total of 80 males and females aged 21 to 50 with temporary thinning hair who meet all eligibility criteria were randomized in this study Within the study there were a total of 6 site visits for each participant during which the following procedures were performed
Visit 1 Screening visit
Signing the informed consent document Demography recording Height weight assessment Vital signs pulse systolic SBP and diastolic DBP blood pressure after 10 minutes of resting position Medical history amp Current medications Hematology A urine pregnancy test for women of childbearing potential Physical examination generalappearance head eyes ears nose throat and oropharynx skin evaluations respiratory cardiovascular abdomengastrointestinal urological system musculoskeletal system and neurological system High-quality clinical and dermoscopic photographs of hair in the target area of the scalp made by dermatoscope High-quality photographs of hair in the target area of the scalp made by digital camera Quality of Life Questionnaire
Visit 2 Randomization
Vital signs pulse systolic SBP and diastolic DBP blood pressure after 10 minutes of resting position Study Intervention randomization participants will be assigned randomly in a 11 ratio to study product or placebo
Visit 3 Day 21 Visit 4 Day 40 Visit 5 Day 60
Vital signs pulse systolic SBP and diastolic DBP blood pressure after 10 minutes of resting position Counting the amount of hair that fell out with each wash Determining the change in hair area compared to the baseline Counting the amount of hair in several control points compared to the baseline
Visit 6 Day 90 End of Study
Vital signs pulse systolic SBP and diastolic DBP blood pressure after 10 minutes of resting position Hematology Counting the amount of hair that fell out with each wash Determining the change in hair area compared to the baseline Counting the amount of hair in several control points compared to the baseline High-quality clinical and dermoscopic photographs of hair in the target area of the scalp made by dermatoscope High-quality photographs of hair in the target area of the scalp made by digital camera Quality of Life Questionnaire Self-assessment Questionnaire
The effectiveness of the treatment was evaluated by considering the increase in hair growth in study supplement-treated subjects which was defined by determining the change in hair area from the baseline and counting the amount of hair in several control points from the baseline comparing to placebo-treated subjects as well as hair washing shampooing for hair shedding counts in study supplement-treated subjects comparing to placebo-treated subjects and the change in patient quality of life questionnaires and self-assessment questionnaires during and following the study
The tolerability of the studied supplement was assessed on the basis of the patient39s subjective complaints the presence and severity of adverse reactionsside effects the data of the patient39s examination and laboratory examination
Visit 1 Screening visit
Signing the informed consent document Demography recording Height weight assessment Vital signs pulse systolic SBP and diastolic DBP blood pressure after 10 minutes of resting position Medical history amp Current medications Hematology A urine pregnancy test for women of childbearing potential Physical examination generalappearance head eyes ears nose throat and oropharynx skin evaluations respiratory cardiovascular abdomengastrointestinal urological system musculoskeletal system and neurological system High-quality clinical and dermoscopic photographs of hair in the target area of the scalp made by dermatoscope High-quality photographs of hair in the target area of the scalp made by digital camera Quality of Life Questionnaire
Visit 2 Randomization
Vital signs pulse systolic SBP and diastolic DBP blood pressure after 10 minutes of resting position Study Intervention randomization participants will be assigned randomly in a 11 ratio to study product or placebo
Visit 3 Day 21 Visit 4 Day 40 Visit 5 Day 60
Vital signs pulse systolic SBP and diastolic DBP blood pressure after 10 minutes of resting position Counting the amount of hair that fell out with each wash Determining the change in hair area compared to the baseline Counting the amount of hair in several control points compared to the baseline
Visit 6 Day 90 End of Study
Vital signs pulse systolic SBP and diastolic DBP blood pressure after 10 minutes of resting position Hematology Counting the amount of hair that fell out with each wash Determining the change in hair area compared to the baseline Counting the amount of hair in several control points compared to the baseline High-quality clinical and dermoscopic photographs of hair in the target area of the scalp made by dermatoscope High-quality photographs of hair in the target area of the scalp made by digital camera Quality of Life Questionnaire Self-assessment Questionnaire
The effectiveness of the treatment was evaluated by considering the increase in hair growth in study supplement-treated subjects which was defined by determining the change in hair area from the baseline and counting the amount of hair in several control points from the baseline comparing to placebo-treated subjects as well as hair washing shampooing for hair shedding counts in study supplement-treated subjects comparing to placebo-treated subjects and the change in patient quality of life questionnaires and self-assessment questionnaires during and following the study
The tolerability of the studied supplement was assessed on the basis of the patient39s subjective complaints the presence and severity of adverse reactionsside effects the data of the patient39s examination and laboratory examination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None