Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
Study NCT ID:
NCT06605768
Status:
COMPLETED
Last Update Posted:
2024-09-20
First Post:
2024-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating the Effects of Dietary Supplement on Hair Thickness and Hair Strength in Individuals with Self-Perceived Thinning Hair
Sponsor:
Nutra Harmony LLC
Organization:
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Nutra Harmony "Biotin, Collagen \& Keratin Beauty Complex" is an oral food/dietary supplement specifically designed to promote hair growth for people suffering from temporary thinning hair. The hypothesis of this clinical research study is that the ingestion of "Biotin, Collagen \& Keratin Beauty Complex" for over a three (3) month period will strengthen the hair and increase hair thickness by promoting the growth of terminal hairs in subjects, ages 21-50 years of age with self-perceived thinning hair associated with poor diet, stress, hormonal influences when compared to using the placebo tablet.
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 treatment(main) and control groups at 3 months. Participants of the main group were prescribed the "Biotin, Collagen \& Keratin Beauty Complex" 30,000 mcg, 60 capsules produced by NUTRA HARMONY LLC, participants of the control group were prescribed placebo (microcrystalline cellulose (MCC)), 60 capsules manufactured by NUTRA HARMONY LLC. The duration of study in both groups of subjects was 3 months and the treatment period continued for 90 days following randomization. A total of 80 males and females aged 21 to 50 with temporary thinning hair who meet all eligibility criteria were randomized in this study. Within the study, there were a total of 6 site visits for each participant, during which the following procedures were performed:
Visit 1 (Screening visit):
Signing the informed consent document Demography recording Height, weight assessment Vital signs: pulse, systolic \[SBP\] and diastolic \[DBP\] blood pressure, after 10 minutes of resting position Medical history \& Current medications Hematology A urine pregnancy test (for women of childbearing potential Physical examination: general/appearance; head, eyes, ears, nose, throat, and oropharynx; skin evaluations; respiratory; cardiovascular; abdomen/gastrointestinal; urological system, musculoskeletal system and neurological system High-quality clinical and dermoscopic photographs of hair in the target area of the scalp made by dermatoscope High-quality photographs of hair in the target area of the scalp made by digital camera Quality of Life Questionnaire
Visit 2 (Randomization):
Vital signs: pulse, systolic \[SBP\] and diastolic \[DBP\] blood pressure, after 10 minutes of resting position Study Intervention randomization: participants will be assigned randomly in a 1:1 ratio to study product or placebo.
Visit 3 (Day 21), Visit 4 (Day 40), Visit 5 (Day 60):
Vital signs: pulse, systolic \[SBP\] and diastolic \[DBP\] blood pressure, after 10 minutes of resting position Counting the amount of hair that fell out with each wash Determining the change in hair area compared to the baseline Counting the amount of hair in several control points compared to the baseline
Visit 6 (Day 90, End of Study):
Vital signs: pulse, systolic \[SBP\] and diastolic \[DBP\] blood pressure, after 10 minutes of resting position Hematology Counting the amount of hair that fell out with each wash Determining the change in hair area compared to the baseline Counting the amount of hair in several control points compared to the baseline High-quality clinical and dermoscopic photographs of hair in the target area of the scalp made by dermatoscope High-quality photographs of hair in the target area of the scalp made by digital camera Quality of Life Questionnaire Self-assessment Questionnaire
The effectiveness of the treatment was evaluated by considering the increase in hair growth in study supplement-treated subjects, which was defined by determining the change in hair area from the baseline and counting the amount of hair in several control points from the baseline comparing to placebo-treated subjects, as well as hair washing (shampooing) for hair shedding counts in study supplement-treated subjects comparing to placebo-treated subjects and the change in patient quality of life questionnaires and self-assessment questionnaires during and following the study.
The tolerability of the studied supplement was assessed on the basis of the patient\'s subjective complaints, the presence and severity of adverse reactions/side effects, the data of the patient\'s examination and laboratory examination.
Visit 1 (Screening visit):
Signing the informed consent document Demography recording Height, weight assessment Vital signs: pulse, systolic \[SBP\] and diastolic \[DBP\] blood pressure, after 10 minutes of resting position Medical history \& Current medications Hematology A urine pregnancy test (for women of childbearing potential Physical examination: general/appearance; head, eyes, ears, nose, throat, and oropharynx; skin evaluations; respiratory; cardiovascular; abdomen/gastrointestinal; urological system, musculoskeletal system and neurological system High-quality clinical and dermoscopic photographs of hair in the target area of the scalp made by dermatoscope High-quality photographs of hair in the target area of the scalp made by digital camera Quality of Life Questionnaire
Visit 2 (Randomization):
Vital signs: pulse, systolic \[SBP\] and diastolic \[DBP\] blood pressure, after 10 minutes of resting position Study Intervention randomization: participants will be assigned randomly in a 1:1 ratio to study product or placebo.
Visit 3 (Day 21), Visit 4 (Day 40), Visit 5 (Day 60):
Vital signs: pulse, systolic \[SBP\] and diastolic \[DBP\] blood pressure, after 10 minutes of resting position Counting the amount of hair that fell out with each wash Determining the change in hair area compared to the baseline Counting the amount of hair in several control points compared to the baseline
Visit 6 (Day 90, End of Study):
Vital signs: pulse, systolic \[SBP\] and diastolic \[DBP\] blood pressure, after 10 minutes of resting position Hematology Counting the amount of hair that fell out with each wash Determining the change in hair area compared to the baseline Counting the amount of hair in several control points compared to the baseline High-quality clinical and dermoscopic photographs of hair in the target area of the scalp made by dermatoscope High-quality photographs of hair in the target area of the scalp made by digital camera Quality of Life Questionnaire Self-assessment Questionnaire
The effectiveness of the treatment was evaluated by considering the increase in hair growth in study supplement-treated subjects, which was defined by determining the change in hair area from the baseline and counting the amount of hair in several control points from the baseline comparing to placebo-treated subjects, as well as hair washing (shampooing) for hair shedding counts in study supplement-treated subjects comparing to placebo-treated subjects and the change in patient quality of life questionnaires and self-assessment questionnaires during and following the study.
The tolerability of the studied supplement was assessed on the basis of the patient\'s subjective complaints, the presence and severity of adverse reactions/side effects, the data of the patient\'s examination and laboratory examination.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: