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Dietary Supplement for Hair Growth and Skin Health

N/A

Recruiting

Led By Jordan DeSantis

Research Sponsored by Nutrition 21, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

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 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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months

Summary

This trial tests a new supplement to see if it can help improve hair and skin health in adults.

Who is the study for?

Adults with concerns about hair appearance or skin aging, who haven't changed their lifestyle significantly recently and will maintain it for the study duration. They must not have used certain hair/skin products or treatments recently, avoid strenuous activity before visits, and refrain from alcohol prior to each visit. Excludes those with certain health conditions, recent substance abuse history, significant recent cosmetic procedures, or using specific medications.

What is being tested?

The trial is testing a new dietary supplement containing biotin and silicon against a placebo to see if it improves hair growth and skin appearance over six months. Participants will take the supplement daily and adhere to specific lifestyle guidelines throughout the study period.

What are the potential side effects?

While side effects are not explicitly listed for this dietary ingredient trial, common side effects of supplements may include digestive discomfort such as bloating or gas, changes in appetite, allergic reactions like rashes or itching if sensitive to ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't used products like Viviscal®, BioSil®, or Nutrafol® for a month and won't use them during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active skin conditions or was treated for skin cancer in the last year.

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I haven't had skin treatments like peels or injections on the test area in the last 6 months.

Select...

I have been diagnosed with Type I Diabetes.

Select...

I have an immune disorder or am taking immunosuppressive medication.

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I haven't used hair growth products like Rogaine or Propecia in the last 6 months and am willing to avoid them during the study.

Select...

I do not have damaged skin, tattoos, or scars near the test area that could affect the study.

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I am experiencing severe hair loss or am completely bald.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hair growth and hair density

Secondary study objectives

Appearance of global final lines and wrinkles

Skin (facial) elasticity

Skin (facial) firmness

+3 more

Other study objectives

Plasma biotin status

Self-Assessment Questionnaire

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: open labelExperimental Treatment1 Intervention

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.

Group II: Active capsulesActive Control1 Intervention

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

Group III: Placebo capsulesPlacebo Group1 Intervention

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

0 / 8Eligibility criteria met