Clinical trial NCT06010745: Effectiveness of a Novel Dietary Ingredient on Hair Growth and Skin's Appearance
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hair Thinning
Facial Skin Texture
Skin Ageing
Keywords: Hair Growth
Skin Texture
Lead sponsor: Nutrition 21, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ALS Beauty and Personal Care
First posted: 2023-08-25
Enrollment: 101
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Scientific problem:

Hair thinning and hair loss are problems that affect both men and women. A variety of diet, lifestyle, life-stage, ethnicity/race, and genetic factors contribute to the thinning and loss of hair. While hair loss is not a condition that is life-threatening, it is life-impacting. Hair loss negatively affects confidence and is associated with decline in quality of life While FDA-approved treatments do exist, access or ease of use may be difficult, or use limited to men. Ingredients like biotin, silicon, and herbals have been marketed for hair, skin, and nail benefits. The studies on their benefits are equivocal, requiring continued research investments to guide evidence-based recommendations for use. The availability of an oral supplement that is safe and effective for everyday use may present a new option for men and women concerned with hair thinning or hair loss.

Specific aims The objective of this randomized, triple-blind, placebo-controlled study is to assess the effectiveness of a novel dietary ingredient formulated with 10 mg of biotin and 10 mg of silicon for improving the appearance of hair and skin in a generally healthy adult population. The primary aim of this study will be to evaluate the impact of daily use on hair growth. In addition, the impact of supplementation on other hair and skin parameters will be evaluated. The study will include both analytical measures and a subjective questionnaire in order to connect analytical outcomes with observable changes in appearance.

Eligibility 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.

Primary outcomes:
measure: Hair growth and hair density
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: Appearance of global final lines and wrinkles
timeFrame: baseline, 3 months, 6 months
measure: Skin (facial) firmness
timeFrame: baseline, 3 months, 6 months
measure: Skin (facial) elasticity
timeFrame: baseline, 3 months, 6 months
measure: Skin hydration
timeFrame: baseline, 3 months, 6 months
measure: Skin texture-Skin Smoothness
timeFrame: baseline, 3 months, 6 months
measure: Skin texture-Skin Roughness
timeFrame: baseline, 3 months, 6 months
Other outcomes:
measure: Self-Assessment Questionnaire
timeFrame: baseline, 3 months, 6 months
measure: Plasma biotin status
timeFrame: baseline, 6 months
Locations:
city: Phoenix
country: United States
facility: ALS Beauty and Personal Care
state: Arizona
Study officials:
affiliation: ALS Beauty and Personal Care
name: Jordan DeSantis
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.