Nutraceutical Supplement With Standardized Botanicals in Males With Thinning Hair

NCT05339958 | Completed

• 1 other identifier: NW-MS-03
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hair Thinning

Keywords

Nutraceutical; Supplement

Outcome Measures

Primary Outcomes (1)

• Change in terminal hair counts

  Changes in terminal hair counts as measured by photorichogram

  Day 180

Secondary Outcomes (9)

• Proportion of subjects with ≥5% hair growth

  Day 180

• Change in total, terminal and vellus and hair count

  Day 180

• Change in mean hair width and mean inter-follicular distance

  Day 180

• Change in terminal to vellus ratio

  Day 180

• Change in mean number of hairs per follicular unit

  Day 180

Study Arms (2)

Nutraceutical Dietary Supplement Capsule

EXPERIMENTAL

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

Placebo Capsule

PLACEBO COMPARATOR

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

Interventions

Nutrafol® Men Hair Growth Nutraceutical DIETARY_SUPPLEMENT

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).

Nutraceutical Dietary Supplement Capsule

Placebo Supplement OTHER

The placebo capsules contain no active ingredients.

Placebo Capsule

Eligibility Criteria

• Age: 21 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutraceutical Wellness Inc.: lead

Study Sites (2)

Ablon Skin Institute and Research Center

Manhattan Beach, California, 90266, United States

Location

Therapeutic Clinical Research

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind, placebo-controlled
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a 6-month, multi-center, randomized, double-blind, placebo-controlled study in adult male subjects with self-perceived hair thinning. Subjects will be randomly assigned to either Nutrafol® Men hair growth supplement or placebo.

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 21, 2022
• Study Start: July 19, 2021
• Primary Completion: April 5, 2023
• Study Completion: April 5, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)