Effectiveness of a Novel Dietary Ingredient on Hair Growth and Skin's Appearance

NCT06010745 | Unknown

• 1 other identifier: ALS 23-029
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the effectiveness of a novel dietary ingredient containing biotin and silicon for promoting hair growth and improving skin's appearance with six months of continuous daily usage among healthy adults.

Conditions

Hair Thinning; Facial Skin Texture; Skin Ageing

Keywords

Hair Growth; Skin Texture

Outcome Measures

Primary Outcomes (1)

• Hair growth and hair density

  Changes in the appearance of hair growth and hair thickness \[bioinstrumental method; image analzysis using FotoFinder Medicam 1000\]

  baseline, 3 months, 6 months

Secondary Outcomes (6)

• Appearance of global final lines and wrinkles

  baseline, 3 months, 6 months

• Skin (facial) firmness

  baseline, 3 months, 6 months

• Skin (facial) elasticity

  baseline, 3 months, 6 months

• Skin hydration

  baseline, 3 months, 6 months

• Skin texture-Skin Smoothness

  baseline, 3 months, 6 months

Other Outcomes (2)

• Self-Assessment Questionnaire

  baseline, 3 months, 6 months

• Plasma biotin status

  baseline, 6 months

Study Arms (3)

Active capsules

ACTIVE COMPARATOR

Dietary ingredient standardized to deliver 10 mg of biotin and 10 mg of silicon per serving (1 capsule/serving).

Dietary Supplement: Biotin and silicon

Placebo capsules

PLACEBO COMPARATOR

The placebo comparator contains only inert ingredients (1 capsule/serving)

Dietary Supplement: Placebo

open label

OTHER

Open-label arm that will involve men who only receive the active dietary ingredient capsules. This arm will run in parallel with the blinded study conducted in women.

Dietary Supplement: Biotin and silicon

Interventions

Biotin and silicon DIETARY_SUPPLEMENT

The active ingredient contains a standardized level of biotin (10 mg) and silicon (10 mg) per serving.

Also known as: Lustriva

Active capsules; open label

Placebo DIETARY_SUPPLEMENT

Inert ingredients only

Placebo capsules

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutrition 21, Inc.: lead
• ALS Beauty and Personal Care: collaborator

Study Sites (1)

ALS Beauty and Personal Care

Phoenix, Arizona, 85012, United States

RECRUITING

Related Publications (1)

• Kalman, D. S., & Hewlings, S. J. (2021). A Randomized Double-Blind Evaluation of a Novel Biotin and Silicon Ingredient Complex on the Hair and Skin of Healthy Women. Journal of Clinical & Experimental Dermatology Research, 12(1), 1-5.

  BACKGROUND

MeSH Terms

Conditions

Alopecia

Interventions

Biotin; Silicon

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Metalloids; Elements; Inorganic Chemicals

Study Officials

• Jordan DeSantis

  ALS Beauty and Personal Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan DeSantis, BS, MHI

CONTACT

602-277-1154; jordan.desantis@alsglobal.com

Brochelle Yazzie, BS

CONTACT

602-277-1154; brochelle.yazzie@alsgobal.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The primary intervention will utilize anonymized/coded products - anonymized/coded by the manufacturer and product codes only kept by supply chain and not directly maintained by study sponsor. The clinical test site will re-code the products, so the study will actually be triple-blind. Open-label products will be made with the active ingredients and this product will be labeled as an active - with no masking of identity to study sponsor, clinical site, or study participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a six (6) month triple-blind, randomized, placebo-controlled study in women with self-perceived hair thinning/loss, with a six (6) month open-label arm in men using only the active product that will be conducted in parallel with the intervention study in women.

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 25, 2023
• Study Start: August 11, 2023
• Primary Completion: June 1, 2024
• Study Completion: November 1, 2024
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)