NCT06010745

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (estimated)
• Sponsor: Nutrition 21, Inc. · Industry
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hair Thinning
• Facial Skin Texture
• Skin Ageing

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Biotin and silicon	The active ingredient contains a standardized level of biotin (10 mg) and silicon (10 mg) per serving.
DIETARY_SUPPLEMENT	Placebo	Inert ingredients only

Timeline

• Start date: 2023-08-11
• Primary completion: 2024-06-01
• Completion: 2024-11-01
• First posted: 2023-08-25
• Last updated: 2023-08-25

Locations

1 site across 1 country: United States