Clinical trial NCT06605768: Study Evaluating the Effects of Dietary Supplement on Hair Thickness and Hair Strength in Individuals with Self-Perceived Thinning Hair
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Thinning
Keywords: Hair thinning
hair thickness
hair strength
hair falling
women
oral supplement
Lead sponsor: Nutra Harmony LLC
Sponsor class: INDUSTRY
First posted: 2024-09-20
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Nutra Harmony "Biotin, Collagen \&amp; 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 \&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 treatment(main) and control groups at 3 months. Participants of the main group were prescribed the "Biotin, Collagen \&amp; 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 \&amp; 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\&#39;s subjective complaints, the presence and severity of adverse reactions/side effects, the data of the patient\&#39;s examination and laboratory examination.

Eligibility criteria: Inclusion Criteria:

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.
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.

Exclusion Criteria:

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\&#39;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.
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.).

Primary outcomes:
measure: Number of hairs in the target area of the scalp.
timeFrame: 90 Days
Secondary outcomes:
measure: Number of shedding hairs after washing.
timeFrame: 90 Days
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Limited Liability Company Treatment and Diagnostic Center ADONIS Plus
Study officials:
References:
citation: Thom E. Efficacy and tolerability of Hairgain in individuals with hair loss: a placebo-controlled, double-blind study. J Int Med Res. 2001 Jan-Feb;29(1):2-6. doi: 10.1177/147323000102900101.
citation: Williamson D, Gonzalez M, Finlay AY. The effect of hair loss on quality of life. J Eur Acad Dermatol Venereol. 2001 Mar;15(2):137-9. doi: 10.1046/j.1468-3083.2001.00229.x.