Hair ThinningNCT05339958
Nutraceutical Supplement With Standardized Botanicals in Males With Thinning Hair
A study testing Nutrafol® Men Hair Growth Nutraceutical in people with Hair Thinning, run by Nutraceutical Wellness Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Thinning
- What is being tested?
- Nutrafol® Men Hair Growth Nutraceutical
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Jul 2021to 5 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ablon Skin Institute and Research Center
Manhattan Beach, California, 90266
Therapeutic Clinical Research
San Diego, California, 92123
About this study
Official title: 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.
Read the 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.
- Conditions
- Hair Thinning
- Being tested
- Nutrafol® Men Hair Growth Nutraceutical, Placebo Supplement
- Keywords
- Nutraceutical, Supplement
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrafol® Men Hair Growth NutraceuticalDietary 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).
Placebo SupplementOther
The placebo capsules contain no active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in terminal hair counts
Changes in terminal hair counts as measured by photorichogram
Measured: Day 180
Secondary outcomes (9)
Proportion of subjects with ≥5% hair growth
Measured: Day 180
Change in total, terminal and vellus and hair count
Changes in all hair counts as measured by photorichogram
Measured: Day 180
Change in mean hair width and mean inter-follicular distance
Changes in hair measurements as measured by photorichogram
Measured: Day 180
Change in terminal to vellus ratio
Changes in hair ratio as measured by photorichogram
Measured: Day 180
Change in mean number of hairs per follicular unit
Changes in hair density as measured by photorichogram
Measured: Day 180
Hair Shedding
Change in Numbers of Hairs Shedded in Hair Pull Test
Measured: 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
Measured: 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.
Measured: 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
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start19 Jul 2021
- Primary completion5 Apr 2023
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair ThinningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutraceutical Wellness Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339958
- Sponsor's protocol ID
- NW-MS-03
- Status last verified
- Jul 2023
- First submitted
- 4 Apr 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05339958
- Acronym / sponsor ID
- NW-MS-03
- Conditions
- Hair Thinning
- Keywords
- Nutraceutical, Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Nutraceutical Wellness Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nutraceutical Dietary Supplement Capsule | Experimental | Dietary Supplement: Nutrafol® Men Hair Growth NutraceuticalThe 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. |
| Placebo Capsule | Placebo comparator | Other: Placebo SupplementThe placebo capsules contain no active ingredients. Subject will be instructed to take four (4) capsules by mouth once daily with a substantial meal. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrafol® Men Hair Growth NutraceuticalNutrafol® 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). | Dietary supplement | Nutraceutical Dietary Supplement Capsule |
| Placebo SupplementThe placebo capsules contain no active ingredients. | Other | Placebo Capsule |
Primary outcome
Change in terminal hair counts
Time frame: Day 180
Changes in terminal hair counts as measured by photorichogram
9 secondary outcomes
Proportion of subjects with ≥5% hair growth
Time frame: Day 180
Change in total, terminal and vellus and hair count
Time frame: Day 180
Change in mean hair width and mean inter-follicular distance
Time frame: Day 180
Change in terminal to vellus ratio
Time frame: Day 180
Change in mean number of hairs per follicular unit
Time frame: Day 180
Hair Shedding
Time frame: Day 180
Subject Assessments
Time frame: Day 180
Blinded Investigator Assessment
Time frame: Day 180
Compiled side effects
Time frame: Day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrafol® Men Hair Growth Nutraceutical in people with Hair Thinning, run by Nutraceutical Wellness Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in terminal hair counts (time frame: Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.