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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hair Thinning
- Sponsor
- Nutrition 21, Inc.
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Hair growth and hair density
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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.
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.
Outcomes
Primary Outcomes
Hair growth and hair density
Time Frame: baseline, 3 months, 6 months
Changes in the appearance of hair growth and hair thickness \[bioinstrumental method; image analzysis using FotoFinder Medicam 1000\]
Secondary Outcomes
- Skin (facial) elasticity(baseline, 3 months, 6 months)
- Skin texture-Skin Roughness(baseline, 3 months, 6 months)
- Appearance of global final lines and wrinkles(baseline, 3 months, 6 months)
- Skin (facial) firmness(baseline, 3 months, 6 months)
- Skin hydration(baseline, 3 months, 6 months)
- Skin texture-Skin Smoothness(baseline, 3 months, 6 months)