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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
101
The active ingredient contains a standardized level of biotin (10 mg) and silicon (10 mg) per serving.
Inert ingredients only
ALS Beauty and Personal Care
Phoenix, Arizona, United States
RECRUITINGHair growth and hair density
Changes in the appearance of hair growth and hair thickness \[bioinstrumental method; image analzysis using FotoFinder Medicam 1000\]
Time frame: baseline, 3 months, 6 months
Appearance of global final lines and wrinkles
Changes in the appearance of facial fine lines and wrinkles \[assessed simultaneously using Canfield VISIA CR System; images evaluated using Vaestro Image Analysis Toolkit from Canfield\]
Time frame: baseline, 3 months, 6 months
Skin (facial) firmness
Changes in firmness of facial skin \[ Cutometer MPA 580\] -measured in mm
Time frame: baseline, 3 months, 6 months
Skin (facial) elasticity
Changes in facial skin elasticity \[Cutometer MPA 580\] - measured in %
Time frame: baseline, 3 months, 6 months
Skin hydration
Changes in the water content of human skin \[changes in skin conductance (AU-Arbitrary Units) using Corneometer CM 825\]
Time frame: 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
Time frame: 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
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Time frame: baseline, 3 months, 6 months