The objective of this study is to assess the effectiveness and safety of a novel dietary supplement containing botanical ingredients for hair thinning in men over the course of six months of continuous daily usage.
Hair thinning is a common condition affecting both men and women that is more recently understood to be the result of multiple causes. Although it is generally a benign condition, hair thinning can have a significant, detrimental impact on self-esteem, psychosocial functioning and the overall quality of life of affected individuals. It can also represent a substantial financial burden on individuals seeking treatment. The objective of this randomized, double-blind, placebo-controlled study is to assess the effectiveness and safety of a novel dietary supplement containing botanical ingredients for hair thinning over the course of six months of continuous daily usage. The study supplement is scientifically formulated to specifically target the multiple underlying causes of hair thinning. In addition to the necessary vitamins, minerals, and proteins to support the nutritional needs of hair, it also contains clinically tested, standardized pharmaceutical-grade botanicals (substances obtained from plants) that target hormones, stress and inflammatory markers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
112
Nutrafol® Men contains patented Synergen Complex® is a blend of proprietary formulation of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant and DHT-inhibiting properties - combined to synergistically combat the multiple underlying factors that compromise hair growth and health. These ingredients include Sensoril Ashwagandha, BCM-95 BioCurcumin, USPlus Saw Palmetto, EVNolMax 20% Tocotrienol/Tocopherol complex, Bioperine (piperine), Cynatine HNS (solubilized keratin), and Capsimax (capsaicin).
The placebo capsules contain no active ingredients.
Ablon Skin Institute and Research Center
Manhattan Beach, California, United States
Therapeutic Clinical Research
San Diego, California, United States
Change in terminal hair counts
Changes in terminal hair counts as measured by photorichogram
Time frame: Day 180
Proportion of subjects with ≥5% hair growth
Time frame: Day 180
Change in total, terminal and vellus and hair count
Changes in all hair counts as measured by photorichogram
Time frame: Day 180
Change in mean hair width and mean inter-follicular distance
Changes in hair measurements as measured by photorichogram
Time frame: Day 180
Change in terminal to vellus ratio
Changes in hair ratio as measured by photorichogram
Time frame: Day 180
Change in mean number of hairs per follicular unit
Changes in hair density as measured by photorichogram
Time frame: Day 180
Hair Shedding
Change in Numbers of Hairs Shedded in Hair Pull Test
Time frame: Day 180
Subject Assessments
Subject self assessments of improvement in hair thickness and quality, quality of life, stress, and perception of the study product using questionnaires
Time frame: Day 180
Blinded Investigator Assessment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Changes in Investigator Hair Quality Global Improvement Scale \& Investigator Hair Growth Global Improvement Scale assessed by physician using standardized 2-D photographs compared to baseline.
Time frame: Day 180
Compiled side effects
All side effects, including all expected or unexpected side effects, categorized by severity (Mild, moderate, severe) and relatedness to the study product or participation
Time frame: Day 180