Hair ThinningNCT06854575
A Safety and Efficacy Study of a Nutraceutical in Aging Males With Thinning Hair
A study testing Dietary Supplement in people with Hair Thinning, run by Nutraceutical Wellness Inc. at 3 sites in United States.
Trial summary
A study to assess the safety and efficacy of a dietary supplement when used over the course of 9 months by men with self-perceived hair thinning. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Thinning
- What is being tested?
- Dietary Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Mar 2025to 15 Sep 2025
- 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 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male, 40 to 65 years of age.
- In good general health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to subject self-report.
- Having Fitzpatrick skin type I-IV.
- Having overall hair thinning (diffuse thinning of the top of the crown or at temples and/or widening part or receding hair line) confirmed by the study dermatologist at baseline (grade III, IIIa, III vertex, IV, or IVa on the Hamilton-Norwood scale).
- With self-perceived thinning hair on the scalp.
- Willing to participate in the Hair Pull Test, in which a trained practitioner will grasp a 4-6mm bundle of hair near the scalp and firmly tug the hair.
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- Having a regular mild, non-medicated shampoo and conditioner (if used) and willing to bring the product(s) in to the first clinic visit for documentation and to continue using the product(s) for the duration of the study.
- Willing to continue using regularly used hair styling products (mousse, hairspray) if used, and not start using any new hair products for the duration of the study.
- Willing to maintain the same hair length, hairstyle, and coloring practices for the duration of the study. Those with color-treated hair must have the color treatment performed at the same time interval prior to each visit.
- Willing to maintain current diet (eg, amount, type, and frequency of food and drink consumed).
- Willing to not wear hats, scarves, or other head coverings on your head during each study visit.
- Willing to refrain from using any topical hair products or treatments on the hair that could affect hair properties (eg, heat treatments, hair relaxers, permanent wave, medicated shampoo, etc) for the duration of the study except for the test material and regular shampoo and conditioner (if used) and styling products.
- Willing to refrain from hair extensions, tight braids, or hair weaves for the duration of the study.
- Willing to refrain from taking any vitamins, minerals, or herbal supplements with claims related to hair growth or benefits during the study, and to not start taking any new vitamins, minerals, or supplements of any kind during the study.
- Willing to avoid using prescription or over-the-counter (OTC) products designed to or claiming to significantly impact hair loss and/or hair growth for the duration of the study.
- Willing to complete a questionnaire regarding sexual experiences (commonly used in clinical trials to assess sexual functioning).
- Willing to provide written informed consent and able to read, speak, write, and understand English.
- Willing to sign a photography release.
- Willing to cooperate and participate by following study requirements for the duration of the study and to report any changes in health status or medications, AE symptoms, or reactions immediately.
Who cannot join
- Having a pregnant partner or a partner that is planning to become pregnant during the study.
- Having a known allergy to any ingredients in the test products.
- Having a history of skin cancer within the past 5 years.
- Having hair extensions, hair weave, tight braids, crew cut, or very short hair (less than 1.5 inches in length).
- Having started any new vitamin, mineral, or herbal supplement within 30 days prior to baseline.
- Smokers with usage >20 cigarettes/day.
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- Who have been diagnosed with hair loss disorders such as alopecia areata, scarring alopecia, traction alopecia, chemical alopecia, trichotillomania or trichorrhexis nodosa, or suffering from moderate to severe hair loss disorder (grade V-VII on the Hamilton-Norwood scale) confirmed by the investigator.
- Having hair loss due to disease, injury, or medical therapy.
- Who have a history of hair transplants or surgical procedures to the head that may have impacted skin anatomy (eg, flaps, grafts, plugs).
- Who have very brittle or severely damaged hair from causes including chemical treatments and excessive tension on the hair (from, eg, tight ponytails or hair extensions).
- Having a history of persistent burning, itching, or stinging of the scalp.
- Having clinically active bacterial, fungal, or viral skin infections or those who have a history of skin infections, according to subject self-report.
- Who are currently using, planning to use, or have used laser/light therapy (such as HairMax, iRestore), microneedling or scalp micropigmentation, or used any prescription or over-the-counter (OTC) products designed to or claiming to significantly impact hair loss and/or hair growth (eg, minoxidil, Rogaine, finasteride, Propecia, Nioxin shampoo, or oral supplements (such as Biotin >500mcg or Nutrafol)) within 6 months of study start.
- Having not used any prescription or over-the-counter (OTC) products designed to or claiming to significantly impact hair loss and/or hair growth (eg, minoxidil, Rogaine, finasteride, Propecia, Nioxin shampoo, or oral supplements (such as Biotin >500mcg or Nutrafol) for at least 6 months prior to baseline, and willing to avoid all such products for the duration of the study.
- Who are currently using, planning to use, or have used anabolic-androgenic steroids (testosterones) or anti-androgen medication (such as spironolactone, flutamide, cyproterone acetate, cimetidine) other than oral contraceptives; platelet-rich plasma (PRP) injections; or tamoxifen within 3 months of study start. (Men currently undergoing hormone/testosterone replacement therapy [TRT] can be eligible for the study if they have maintained a stable dose for at least 6 months prior to enrollment and stay on the same dose throughout the study.)
- Having started blood pressure medications or aldactone within 3 months of enrollment.
- Having a health condition and/or pre-existing or dormant dermatologic disease on the scalp (eg, excessive dandruff, psoriasis, eczema, seborrheic dermatitis, severe excoriations) that the Investigator or designee deems inappropriate for participation or could interfere with the outcome of the study.
- Having observable sunburn, suntan, scars, nevi, tattoos, or other dermal conditions on the scalp that might influence the test results in the opinion of the Investigator or designee.
- Having a history of immunosuppression/immune deficiency disorders (including HIV infection, AIDS, multiple sclerosis, Crohn's disease, rheumatoid arthritis), organ transplant (heart, kidney, etc), or currently using oral or systemic immunosuppressive medications and biologics (eg, azathioprine, belimumab, Cimzia, Cosentyx, cyclophosphamide, cyclosporine, Enbrel, Humira, Imuran, Kineret, mycophenolate mofetil, methotrexate, Orencia, prednisone, Remicade, Rituxan, Siliq, Simponi, Stelara, Taltz) and/or undergoing radiation or chemotherapy as determined by study documentation.
- Currently using or having regularly used corticosteroids (systemic or topical, not nasal or ocular) within the past 4 weeks (including but not limited to betamethasone, clobetasol, desoximetasone, diflorasone, fluocinonide, halcinonide, and halobetasol).
- Having a disease such as asthma, diabetes, epilepsy, hypertension, hyperthyroidism, or hypothyroidism that is not controlled by diet or medication. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc.
- Having started a long-term medication within the last 2 months.
- Having any planned surgeries or invasive medical procedures during the study. Noninvasive medical procedures or surgeries will be reviewed for their impact on the study outcome and acceptability by the Investigator or designee.
- Currently participating in any other clinical trial at SGS or another research facility or doctor's office.
- Having a history of unstable, not controlled, or chronic depression or bipolar disease or any other disorder that may impact the participation in the study, according to subject self-report.
- Having a self-reported history of recent blood work indicating iron deficiency, bleeding disorders, or platelet dysfunction syndrome or currently receiving anticoagulant therapy.
- Having participated in any clinical trial involving the scalp and/or hair within 2 weeks before study enrollment at SGS or another research facility or doctor's office.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
SGS Elizabeth Research Center
Elizabeth, New Jersey, 07208
SGS Phoenix Research Center
Phoenix, Arizona, 85029
SGS Dallas Research Center
Richardson, Texas, 75081
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 Aging Males With Thinning Hair
A study to assess the safety and efficacy of a dietary supplement when used over the course of 9 months by men with self-perceived hair thinning.
Read the detailed description
This multicenter, randomized, double-blind, placebo-controlled clinical trial is being conducted to assess the safety and efficacy of a dietary supplement with standardized botanicals compared to a placebo when used over the course of 9 months by men with self-perceived hair thinning.
- Conditions
- Hair Thinning
- Being tested
- Dietary Supplement, Placebo
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary SupplementDietary supplement
Oral dietary supplement
PlaceboOther
Placebo pill
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Dietary Supplement Receives: Dietary Supplement: Dietary Supplement |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair Growth Global Improvement Scale rating at 6 months
Blinded Investigator mean Hair Growth Global Improvement Scale rating at 6 months for treatment group as compared to placebo
Measured: 6 months
Secondary outcomes (1)
Investigator Hair Quality Global Improvement Scale at 6 month
Blinded Investigator Hair Quality Global Improvement Scale mean score at 6 months for treatment group as compared to placebo
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start10 Mar 2025
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Why it stopped: Sponsor Business Decision
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 155 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
- NCT06854575
- Sponsor's protocol ID
- NW-MSS-01
- Status last verified
- Nov 2025
- First submitted
- 25 Feb 2025
- Last updated
- 4 Dec 2025
- 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 4 Dec 2025. 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 Aging Males With Thinning Hair
- ClinicalTrials.gov ID
- NCT06854575
- Acronym / sponsor ID
- NW-MSS-01
- Conditions
- Hair Thinning
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Business Decision
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Nutraceutical Wellness Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 3 Mar 2025 (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.
A study to assess the safety and efficacy of a dietary supplement when used over the course of 9 months by men with self-perceived hair thinning.
Detailed description
This multicenter, randomized, double-blind, placebo-controlled clinical trial is being conducted to assess the safety and efficacy of a dietary supplement with standardized botanicals compared to a placebo when used over the course of 9 months by men with self-perceived hair thinning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Dietary Supplement: Dietary SupplementDietary Supplement |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male, 40 to 65 years of age.
- In good general health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to subject self-report.
- Having Fitzpatrick skin type I-IV.
- Having overall hair thinning (diffuse thinning of the top of the crown or at temples and/or widening part or receding hair line) confirmed by the study dermatologist at baseline (grade III, IIIa, III vertex, IV, or IVa on the Hamilton-Norwood scale).
- With self-perceived thinning hair on the scalp.
Key exclusion criteria (27 listed)
- Having a pregnant partner or a partner that is planning to become pregnant during the study.
- Having a known allergy to any ingredients in the test products.
- Having a history of skin cancer within the past 5 years.
- Having hair extensions, hair weave, tight braids, crew cut, or very short hair (less than 1.5 inches in length).
- Having started any new vitamin, mineral, or herbal supplement within 30 days prior to baseline.
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 |
|---|---|---|
| Dietary SupplementOral dietary supplement | Dietary supplement | Active |
| PlaceboPlacebo pill | Other | Placebo |
Primary outcome
Hair Growth Global Improvement Scale rating at 6 months
Time frame: 6 months
Blinded Investigator mean Hair Growth Global Improvement Scale rating at 6 months for treatment group as compared to placebo
1 secondary outcome
Investigator Hair Quality Global Improvement Scale at 6 month
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Sponsor Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement in people with Hair Thinning, run by Nutraceutical Wellness Inc. at 3 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 19 inclusion and 27 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: stopped early, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early (reason given: Sponsor Business Decision). Results are not available in the source record.
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?
Hair Growth Global Improvement Scale rating at 6 months (time frame: 6 months). 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 4 Dec 2025.