Clinical trial No longer in our active list Interventional Ages 35 to 70

Assessing a new dietary ingredient for hair growth and skin improvement

Official title: A Randomized, Triple-blind, Placebo-controlled Study Evaluating the Efficacy of a Novel Dietary Ingredient for Improving Hair Growth and Skin's Appearance Among Healthy Adults

Run by Nutrition 21, Inc. · NCT06010745 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing a new dietary ingredient with biotin and silicon to see if it can help healthy adults grow more hair and improve their skin over six months.

More Hair Thinning trials

Quick facts

Study typeInterventional
Ages35 Years to 70 Years
SexAll
Enrollment101 (estimated)
SponsorNutrition 21, Inc.
Industry-sponsored
Drugs / interventionsbelimumab, chemotherapy, radiation, methotrexate, cyclophosphamide, prednisone
Locations1 site (Phoenix, Arizona)
Trial IDNCT06010745 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include healthy adults with self-reported concerns about their hair and skin appearance.

Probably not a fit

Patients with significant dermatological or systemic disorders that could interfere with the study results may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a novel dietary ingredient containing biotin and silicon in promoting hair growth and enhancing skin appearance over six months of daily use among healthy adults. It is a randomized, triple-blind, placebo-controlled trial designed to assess both objective and subjective outcomes related to hair and skin health. Participants will be monitored for changes in hair growth and skin texture, with a focus on safety and tolerability of the supplement. The study aims to provide evidence-based recommendations for the use of this dietary ingredient in addressing hair thinning and skin aging.

Why it matters

Potential benefit: If successful, this study could provide a new, effective oral supplement option for individuals experiencing hair thinning and skin aging.

How similar studies have gone: While there have been studies on biotin and silicon for hair and skin benefits, this specific combination and approach is relatively novel and requires further investigation.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Individuals with self-reported concerns with the appearance of their hair and/or skin (i.e., history of breaking hair / wrinkles or discoloration of the skin).
* In good general health as determined by ALS staff.
* Individuals who, at baseline, are free of any dermatological or systemic disorder, which would interfere with the results, at the discretion of the Investigator.
* Individuals who agree to provide a comprehensive medical history and concomitant medication list for review by ALS staff.
* Individuals who will read, understand and sign an informed consent document and photography release form.
* Individuals who agree to use the test product as instructed by the testing facility and complete the full course of the study.
* Individuals who agree to maintain a stable lifestyle with no significant changes in diet, supplements, medications, or exercise routine.
* Individuals who agree to maintain a consistent routine of washing their hair and skin.
* Individuals with natural hair only at start and for the duration of trial (no extensions, weaves, pieces, etc.). Dyed hair will be permitted for individuals who agree to maintain the same hair color for the study duration.
* Individuals who have not participated in another clinical study or for the past 30 days and agree to not concurrently participate in any other studies.
* Individuals who will agree to continue to use their current personal care products (e.g. shampoo, conditioner, hair spray, mousse, lotions, creams, sunscreen, cosmetics, etc.) for the duration of the study and agree to not incorporate any new products with the exception of those provided by ALS. Subjects must have a safe use history of their current products for at least 30 days prior to screening.
* Individuals who agree to maintain the same length, hair styling and coloring practices for the duration of the study.
* Individuals who agree not to utilize any new over the counter, commercial or other products that are marketed and promoted for enhancing aspects of their hair or skin (e.g., Viviscal®, BioSil®, Nutrafol®, etc.) for the entire duration of the study and confirms not using them one month prior to screening. This includes biotin-based supplements that provide 1000 micrograms or more biotin and/or contain biotin in combination with other ingredients promoted for hair and skin benefits.
* Individuals who agree to refrain from strenuous activity/exercise for at least 24 hours prior to each study visit.
* Individuals who agree to refrain from alcohol-containing food or beverages for at least 24 hours prior to each study visit.
* Individuals who agree to visit a 3rd party off-site laboratory and participate in a blood draw (N=40).
* Individuals who agree to avoid all tanning (sun or artificial such as tanning beds, sprays and other topical applications) and excessive sun exposure for the entire duration of the study and confirms avoiding these elements for 2 weeks prior to screening.

Exclusion Criteria:

* Individuals who have had a history of any acute or chronic disease that could interfere with or increase the risk on study participation.
* Individuals with an active (flaring) disease or chronic skin allergies (atopic dermatitis, eczema, psoriasis, severe acne), or had recently treated skin cancer (within the last 12 months) or currently undergoing treatment for cancer.
* Individuals with a history of drug or alcohol abuse in the 12 months prior to screening.
* Individuals with a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara) and/or radiation as determined by study documentation.
* Individuals with damaged skin at or in close proximity to test sites (e.g., sunburn, tattoos, scars, excessive hair, or other disfigurations) that would impact study assessments.
* Individuals having severe hair loss or are completely bald.
* Individuals with white or very light-colored hair that is not able to be analyzed using the outlined instrumentation.
* Individuals who have any history, which, in the Investigator's opinion, indicates the potential for harm to the subject or could place the validity of the study in jeopardy.
* Individuals who have had any medical procedure, such as laser resurfacing, microdermabrasion, retinol or AHA treatments, hyaluronic injections, collagen, or chemical peels to the test sites within the last 6 months (including Botox, Restylyn, or other fillers).
* Individuals who are currently using or during the last 6 months have used, Retin A, or other Rx/OTC Retinyl A, or other astringent derived products or alpha hydroxyl acid treatments for photo-aging and fine lines/wrinkles.
* Individuals who have used any products or devices to promote scalp hair growth (e.g., finasteride, minoxidil, Rogaine, Propecia) within 6 months of screening; or refusal to refrain from any of these for the study duration.
* Individuals who have started, stopped, or changed hormone replacement therapy (HRT) within 6 months prior to screening.
* Subjects with history or presence of any clinically significant cardiovascular (light headedness/fainting or drops in blood pressure or recent myocardial infarction), respiratory (including uncontrolled asthma or allergies), renal, hepatic, gastrointestinal, hematologic, neurologic, any type of cancer that required radiation and/or chemotherapy for 1 year prior to study, metabolic disease or disorder, including guanidinoacetate methyltransferase deficiency and herpes (HSV-1), or any uncontrolled medical illness which in the opinion of the Investigator would jeopardize the safety of the subject, interfere with study assessments, or impact the validity of the study.
* Individuals who indicate that they are pregnant, planning a pregnancy or nursing.
* Individuals who have been medically diagnosed with Type I Diabetes.
* Individuals who have a known history of hypersensitivity to any cosmetics, personal care products, and/or fragrances.
* Individuals who are employees of the company.

Where it's running

  • ALS Beauty and Personal Care
    Phoenix, Arizona, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.