Clinical trial NCT06362941: Evaluation of an Oral Hair Supplement to Improve Hair Strength and Support Growth in Women and Men
Official title: A Single-Center Prospective Evaluation of an Oral Hair Supplement to Improve Hair Strength and Support Growth in Women and Men with Self-Perceived Hair Thinning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Thinning
Lead sponsor: Nutraceutical Wellness Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment 6-month, single-center, prospective interventional study
Primary purpose: TREATMENT

Brief summary: A single-center, open-label, prospective study to demonstrate the efficacy of an oral supplement to improve the strength and support the growth of thinning hair in men and women with self-perceived hair thinning.

Detailed description: Female and male subjects will be enrolled in this single-site, open-label, prospective, interventional study evaluating 5 treatment regimens to improve the appearance of thinning hair. All treatment regimens are commercially available nutraceutical hair growth supplements. 50 subjects will be enrolled into each of the 5 supplement groups. Subjects will undergo a baseline, 90 day, and 180 day visit and will have compliance phone calls at Days 45 and 135. Study assessments will include a dermatologist investigator hair assessment, a hair pull test, light microscope hair shaft diameter assessment, and a subject questionnaire.

Eligibility criteria: Inclusion Criteria:

1. Female or male subjects with concerns and/or signs of hair thinning.
2. The subjects must meet the age characteristics based on their supplement group assignment.
3. Subjects are Fitzpatrick Skin Types I to VI.
4. Subjects must be in good general health.
5. Subjects must be classified with thinning hair by the study dermatologist.
6. Willing to maintain the same hair length, hairstyle, and coloring practices for the duration of the study. Subjects who have color-treated hair must have the color treatment performed at the same time interval prior to each visit.
7. Willing to use a mild non-medicated shampoo and conditioner for the duration of the study (medicated shampoo and conditioner refer to any prescription shampoo or conditioner as well as any over-the counter medicated shampoo or conditioner, such as those for treatment of dandruff or promoting hair growth).
8. Willing and able to adhere to the same dietary lifestyles for the duration of the study
9. Subjects must express willingness to cooperate with the investigator and comply to study requirements.
10. Subjects must demonstrate the ability to read and understand all the items in the informed consent document.
11. Subjects must agree not to use any other hair supplements or start a new vitamin supplement during the study.
12. Subject has signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of Human Subjects."
13. Subject is dependable and able to follow directions and is willing to comply with the schedule of visits.

Exclusion Criteria:

1. Any previous or current acute or chronic medical or hair condition, which in the investigator's opinion, may interfere with the study results or increase the study participation risks to the subject.
2. Subjects possessing signs of severe female or male pattern hair loss or alopecia (including androgenetic and traction alopecia) as determined by the study dermatologist.
3. Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
4. Subjects who are not willing to use only the assigned oral study supplement and no new oral supplements during the study.
5. Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study product.
6. Subjects, who are pregnant, breast feeding, or planning a pregnancy.
7. Subjects with clinically significant unstable medical disorders.
8. Subjects who are unwilling or unable to comply with the requirements of the protocol.
9. Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and/or follow the requirements of the study.
10. Subjects with any planned surgeries and/or invasive medical procedures during the course of the study.
11. History of surgical correction of hair loss on the scalp (i.e., hair transplant).
12. Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within the 6 months prior to the Baseline Visit.
13. 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 Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
14. 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 (the initiation of HRT or birth control should not have been associated with the initiation of hair loss/thinning).
15. History of burning, flaking, itching, and stinging of the scalp.
16. Utilization of low-level lasers for hair growth in the last three months.
17. Known history or recent blood work indicating iron deficiency, bleeding disorders or platelet dysfunction syndrome as well as subjects receiving anticoagulant therapy or smokers with usage \>20 cigarettes/day.
18. Use of any medications or medicated shampoos that are known to potentially cause hair loss or affect hair growth, as determined by the Investigator or qualified sub-investigator.

Primary outcomes:
measure: Change in hair shaft diameter compared to baseline at Day 180.
timeFrame: 180 days
measure: Change in hair shaft diameter compared to baseline at Day 90.
timeFrame: 90 days
Secondary outcomes:
measure: Change in broken hairs recovered from the hair pull test compared to baseline at Day 180
timeFrame: 180 days
measure: Change in broken hairs recovered from the hair pull test compared to baseline at Day 90
timeFrame: 90 days
measure: Change in hair breakage during the hair pull test compared to baseline at Day 180
timeFrame: 180 Days
measure: Change in hair breakage during the hair pull test compared to baseline at Day 90
timeFrame: 90 Days
measure: Change in the number of hairs recovered from the hair pull test compared to baseline at Day 180
timeFrame: 180 Days
measure: Change in the number of hairs recovered from the hair pull test compared to baseline at Day 90
timeFrame: 90 Days
measure: Subject Self-Perceived Improvement in Hair Quality at Day 180
timeFrame: 180 Days
measure: Subject Self-Perceived Improvement in Hair Quality at Day 90
timeFrame: 90 Days
Other outcomes:
Locations:
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
Study officials:
References: