Evaluation of an Oral Hair Supplement to Improve Hair Strength and Support Growth in Women and Men

Completed · Not applicable

Conditions studied: Hair Thinning

In brief

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.

Key facts

Study ID

NCT06362941

Run by

Nutraceutical Wellness Inc.

People needed

250

Starts

2024-05-20

Expected to finish

2025-02-18

Last updated by the study team

2025-03-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Female or male subjects with concerns and/or signs of hair thinning.
• The subjects must meet the age characteristics based on their supplement group assignment.
• Subjects are Fitzpatrick Skin Types I to VI.
• Subjects must be in good general health.
• Subjects must be classified with thinning hair by the study dermatologist.
• 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.
• 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).
• Willing and able to adhere to the same dietary lifestyles for the duration of the study
• Subjects must express willingness to cooperate with the investigator and comply to study requirements.
• Subjects must demonstrate the ability to read and understand all the items in the informed consent document.
• Subjects must agree not to use any other hair supplements or start a new vitamin supplement during the study.
• Subject has signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of Human Subjects."
• Subject is dependable and able to follow directions and is willing to comply with the schedule of visits.

You may not qualify if…

• 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.
• Subjects possessing signs of severe female or male pattern hair loss or alopecia (including androgenetic and traction alopecia) as determined by the study dermatologist.
• Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
• Subjects who are not willing to use only the assigned oral study supplement and no new oral supplements during the study.
• Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study product.
• Subjects, who are pregnant, breast feeding, or planning a pregnancy.
• Subjects with clinically significant unstable medical disorders.
• Subjects who are unwilling or unable to comply with the requirements of the protocol.
• 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.
• Subjects with any planned surgeries and/or invasive medical procedures during the course of the study.
• History of surgical correction of hair loss on the scalp (i.e., hair transplant).
• 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.
• 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
• 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).
• History of burning, flaking, itching, and stinging of the scalp.
• Utilization of low-level lasers for hair growth in the last three months.
• 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.
• 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.

Where it is running

• Dermatology Consulting Services — High Point, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.