Nutraceutical Supplement With Standardized Botanicals in Males With Thinning Hair

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Nutraceutical Supplement With Standardized Botanicals in Males With Self-Perceived Thinning Hair

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.

Study Overview

• Status: Completed
• Conditions: Hair Thinning
• Intervention / Treatment: Dietary supplement: Nutrafol® Men Hair Growth Nutraceutical; Other: Placebo Supplement

Detailed Description

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
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Manhattan Beach, California, United States, 90266
      • Ablon Skin Institute and Research Center
    • San Diego, California, United States, 92123
      • Therapeutic Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Males between 21-55 years of age with self-perceived thinning
• Voluntarily sign and date an informed consent agreement and photo release form approved by the Institutional Review Board
• Clinically confirmed to have hair thinning or loss by the investigator or qualified sub-investigator via physical exam, including only subjects with male pattern hair loss with frontal and/or vertex patterns II, IIA, III, IIIv and IV using the Norwood classification of patterned hair loss in males.
• General good health, as determined by the Investigator or qualified sub-investigator
• Willing and able to attend all study visits and comply with the test product daily instructions.
• Willing to maintain the same hair style and same color for the duration of the study.
• Willing to use a mild non-medicated shampoo and conditioner for the duration of the study (medicated shampoo and conditioner refer to any prescription shampoo or conditioner as well as any over-the counter medicated shampoo or conditioner, such as those for treatment of dandruff or promoting hair growth).
• Willing and able to cooperate with the requirements of the study.
• Able to complete and understand the various rating instruments.

Exclusion Criteria:

• Individuals who have experienced serious complications due to COVID-19 previously or during the study as determined by the investigator.
• Clinical diagnosis of hair loss disorder such as alopecia areata, or scarring forms of alopecia.
• Subjects with male pattern hair loss with frontal and/or vertex patterns I, IIIA, IVA, V, VA, VI, VII using the Norwood classification of patterned hair loss in males.
• Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
• Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis), cuts and or abrasions on the scalp or condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of the Investigator or qualified sub-investigator, might put the subject at risk or interfere with the study conduct or evaluations.
• History of surgical correction of hair loss on the scalp (i.e. hair transplant).
• Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within the 6 months prior to the Baseline Visit.
• Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, progesterone, and bicalutamide) within 3 months prior to the Baseline Visit.
• History of burning, flaking, itching, and stinging of the scalp.
• History of malignancy (except cutaneous squamous cell carcinoma and basal cell carcinoma) or currently undergoing chemotherapy or radiation treatments.
• A known history of autoimmune thyroid disease, any other thyroid disorder/abnormality or other autoimmune disorders that in the opinion of the Investigator or qualified sub-investigator may interfere with the study treatment.
• A known history of unstable or chronic depression or bipolar disease or any other condition that may impact the subject's participation in the opinion of the investigator or qualified sub-investigator.
• A known allergy to any of the ingredients in the investigational product.
• Utilization of low-level lasers for hair growth in the last three months.
• Any condition that the Investigator thinks may put the subject at risk or interfere with their participation in the study.
• Known history or recent blood work indicating iron deficiency, bleeding disorders or platelet dysfunction syndrome as well as subjects receiving anticoagulant therapy or smokers with usage >20 cigarettes/day.
• Use of any medications or medicated shampoos that are known to potentially cause hair loss or affect hair growth, as determined by the Investigator or qualified sub-investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutraceutical Dietary Supplement Capsule; The nutraceutical capsules are comprised of standardized, natural, medical-grade ingredients. Subject will be instructed to take four (4) capsules by mouth once daily with a substantial meal.	Dietary supplement: Nutrafol® Men Hair Growth Nutraceutical; 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).
Placebo Comparator: Placebo Capsule; The placebo capsules contain no active ingredients. Subject will be instructed to take four (4) capsules by mouth once daily with a substantial meal.	Other: Placebo Supplement; The placebo capsules contain no active ingredients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in terminal hair counts	Changes in terminal hair counts as measured by photorichogram	Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with ≥5% hair growth		Day 180
Change in total, terminal and vellus and hair count	Changes in all hair counts as measured by photorichogram	Day 180
Change in mean hair width and mean inter-follicular distance	Changes in hair measurements as measured by photorichogram	Day 180
Change in terminal to vellus ratio	Changes in hair ratio as measured by photorichogram	Day 180
Change in mean number of hairs per follicular unit	Changes in hair density as measured by photorichogram	Day 180
Hair Shedding	Change in Numbers of Hairs Shedded in Hair Pull Test	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	Day 180
Blinded Investigator Assessment	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.	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	Day 180

Collaborators and Investigators

• Sponsor: Nutraceutical Wellness Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Actual): April 5, 2023
• Study Completion (Actual): April 5, 2023

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Nutraceutical; Supplement
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hair Diseases; Alopecia; Alopecia Areata; Hypotrichosis
• Other Study ID Numbers: NW-MS-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No