The purpose of the study is to evaluate the safety and efficacy of a vegan nutraceutical supplement with standardized botanicals in females leading a more plant-based lifestyle with self-perceived thinning hair
Hair loss 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 loss 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. This is a 6-month, multi-center, single-arm prospective interventional study in adult female subjects who follow a plant-based diet with self-perceived hair thinning as confirmed by a dermatologist. The objective of this study is to assess the efficacy and safety of novel women's vegan supplement for hair growth.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Nutrafol's Vegan Women's Hair Supplement with 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, Curcumin, Saw Palmetto, 20% Tocotrienol/Tocopherol complex, and capsaicin in combination with other vegan nutrients used to support hair health such as Pea Sprout Extract, Bamboo, and a new innovative Maldavian Dragonhead flower extract.
Ablon Skin Institute and Research Center
Manhattan Beach, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
Change in terminal hair counts at Day 180 relative to baseline (Day 0)
Terminal Hair Counts
Time frame: 180 Days
Change in total, terminal and vellus and hair counts compared to baseline (Day 0)
All Hair Counts
Time frame: 180 Days
Change in Investigator Hair Quality Global Improvement Scale & Investigator Hair Growth Global Improvement Scale assessed by physician using standardized 2-D photographs compared to baseline.
Investigator Score using a 0 to 10 VAS scale
Time frame: 180 Days
Hair shedding pull test compared to baseline.
Hair Pull Test
Time frame: 180 Days
Subjective assessments of change in hair growth, appearance, and satisfaction measured with Subject Quality of Life Assessment
Subject self-assessments of satisfaction and perception using a 4-pt scale
Time frame: 180 Days
Compiled side effects, including all expected or unexpected side effects
All side effects occurring during the study, categorized by severity (Mild, moderate, severe) and relatedness to the study product or participation
Time frame: All visits until 180 Days
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