Hair ThinningNCT06010745
Effectiveness of a Novel Dietary Ingredient on Hair Growth and Skin's Appearance
A study testing Biotin and silicon in people with Hair Thinning and Facial Skin Texture, run by Nutrition 21, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hair Thinning, Facial Skin Texture, Skin Ageing
- What is being tested?
- Biotin and silicon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2023to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
ALS Beauty and Personal Care
Phoenix, Arizona, 85012
Jordan DeSantis, 602-277-1154, jordan.desantis@alsglobal.com
About this study
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
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.
Read the 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.
- Conditions
- Hair Thinning, Facial Skin Texture, Skin Ageing
- Being tested
- Biotin and silicon, Placebo
- Keywords
- Hair Growth, Skin Texture
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biotin and siliconDietary supplement
Also called Lustriva
The active ingredient contains a standardized level of biotin (10 mg) and silicon (10 mg) per serving.
PlaceboDietary supplement
Inert ingredients only
| Study group | Role | What they receive |
|---|---|---|
| Active capsules | Active comparator | Dietary ingredient standardized to deliver 10 mg of biotin and 10 mg of silicon per serving (1 capsule/serving). Receives: Dietary Supplement: Biotin and silicon |
| Placebo capsules | Placebo comparator | The placebo comparator contains only inert ingredients (1 capsule/serving) Receives: 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. Receives: Dietary Supplement: Biotin and silicon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair growth and hair density
Changes in the appearance of hair growth and hair thickness [bioinstrumental method; image analzysis using FotoFinder Medicam 1000]
Measured: baseline, 3 months, 6 months
Secondary outcomes (6)
Appearance of global final lines and wrinkles
Changes in the appearance of facial fine lines and wrinkles [assessed simultaneously using Canfield VISIA CR System; images evaluated using Vaestro Image Analysis Toolkit from Canfield]
Measured: baseline, 3 months, 6 months
Skin (facial) firmness
Changes in firmness of facial skin [ Cutometer MPA 580] -measured in mm
Measured: baseline, 3 months, 6 months
Skin (facial) elasticity
Changes in facial skin elasticity [Cutometer MPA 580] - measured in %
Measured: baseline, 3 months, 6 months
Skin hydration
Changes in the water content of human skin [changes in skin conductance (AU-Arbitrary Units) using Corneometer CM 825]
Measured: baseline, 3 months, 6 months
Skin texture-Skin Smoothness
Changes in skin texture [measured optically using VisioScan VC 98] - Evaluated using SELS (Surface Evaluation of the Living Skin)- SEsm index-AU- Arbitrary Units
Measured: baseline, 3 months, 6 months
Skin texture-Skin Roughness
Changes in skin texture [measured optically using VisioScan VC 98] - Evaluated using SELS (Surface Evaluation of the Living Skin);- SEr index-AU- Arbitrary Units
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start11 Aug 2023
- Primary completionJun 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hair ThinningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutrition 21, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ALS Beauty and Personal Care
- Responsible party
- Sponsor
- Investigators
- Jordan DeSantis, Principal investigator, ALS Beauty and Personal Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010745
- Sponsor's protocol ID
- ALS 23-029
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06010745
- Acronym / sponsor ID
- ALS 23-029
- Conditions
- Hair Thinning, Facial Skin Texture, Skin Ageing
- Keywords
- Hair Growth, Skin Texture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Nutrition 21, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ALS Beauty and Personal Care
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active capsules | Active comparator | Dietary Supplement: Biotin and siliconDietary ingredient standardized to deliver 10 mg of biotin and 10 mg of silicon per serving (1 capsule/serving). |
| Placebo capsules | Placebo comparator | Dietary Supplement: PlaceboThe placebo comparator contains only inert ingredients (1 capsule/serving) |
| open label | Other | Dietary Supplement: Biotin and siliconOpen-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. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biotin and siliconAlso: LustrivaThe active ingredient contains a standardized level of biotin (10 mg) and silicon (10 mg) per serving. | Dietary supplement | Active capsules, open label |
| PlaceboInert ingredients only | Dietary supplement | Placebo capsules |
Primary outcome
Hair growth and hair density
Time frame: baseline, 3 months, 6 months
Changes in the appearance of hair growth and hair thickness [bioinstrumental method; image analzysis using FotoFinder Medicam 1000]
6 secondary outcomes
Appearance of global final lines and wrinkles
Time frame: baseline, 3 months, 6 months
Skin (facial) firmness
Time frame: baseline, 3 months, 6 months
Skin (facial) elasticity
Time frame: baseline, 3 months, 6 months
Skin hydration
Time frame: baseline, 3 months, 6 months
Skin texture-Skin Smoothness
Time frame: baseline, 3 months, 6 months
Skin texture-Skin Roughness
Time frame: baseline, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- BackgroundKalman, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan DeSantis principal investigator
ALS Beauty and Personal Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biotin and silicon in people with Hair Thinning and Facial Skin Texture, run by Nutrition 21, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordan DeSantis, BS, MHI (602-277-1154, jordan.desantis@alsglobal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair growth and hair density (time frame: baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06010745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.