Nutraceutical Supplement With Standardized Botanicals in Males With Thinning Hair

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    120
  • sponsor
    Nutraceutical Wellness Inc.
Updated on 6 May 2022
dandruff
Accepts healthy volunteers

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.

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.

Details
Condition Hair Thinning
Treatment Placebo supplement, Nutrafol® Men Hair Growth Nutraceutical
Clinical Study IdentifierNCT05339958
SponsorNutraceutical Wellness Inc.
Last Modified on6 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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