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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hair growth and hair density

Secondary outcome measures

Appearance of global final lines and wrinkles

Skin (facial) elasticity

Skin (facial) firmness

+3 more

Other outcome measures

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nutrition 21, Inc.Lead Sponsor

6 Previous Clinical Trials

781 Total Patients Enrolled

ALS Beauty and Personal CareUNKNOWN

2 Previous Clinical Trials

87 Total Patients Enrolled

Jordan DeSantisPrincipal InvestigatorALS Beauty and Personal Care

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical research extend to individuals in their mid-thirties or older?

"The eligibility criteria for this medical trial stipulate that patients should be between 35 and 70 years of age. Additionally, 16 studies are available to individuals below the age of 18 while 65 studies are suitable for those over 65."

Answered by AI

To whom is this medical trial most suited?

"To qualify for this trial, prospective participants must have alopecia and be between 35-70 years old. A maximum of 101 individuals will ultimately join the study."

Answered by AI

To what extent is the participant pool of this experiment expanding?

"Affirmative, according to the information on clinicaltrials.gov this study is actively looking for research subjects. It was first listed on August 11th 2023 and recently updated on August 22nd 2023, aiming to garner 101 participants from a single medical centre."

Answered by AI

Are participants sought for this clinical investigation?

"According to clinicaltrials.gov, this medical trial is still open for recruitment and was most recently updated on August 22nd 2023. It has been accepting applicants since the 11th of August in that same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Effectiveness of a Novel Dietary Ingredient on Hair Growth and Skin's Appearance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06010745.

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