Hair LossNCT03709563
Oral Nutraceutical Supplement With Standardized Botanicals in Males With Self-Perceived Thinning Hair and Loss
A study testing Oral Nutraceutical Supplement in people with Hair Loss and Hair Thinning, run by DeNova Research at 1 site in United States.
Trial summary
Hair loss study in men with self-perceived thinning hair and loss Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Loss, Hair Thinning
- What is being tested?
- Oral Nutraceutical Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 1 Jun 2021
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males between 21-45 years of age, inclusive
- Have self-reported thinning or hair loss for more than 3 months prior to screening
- Clinically confirmed to have hair loss or thinning by the investigator via physical exam, including subjects with male pattern hair loss with frontal and vertex patterns II, IIIv or IV using the Norwood Hamilton Hair Loss Scale (NHS).
- In good general health, as determined by the Investigator
- Willing and able to attend all study visits
- Willing to maintain the same hair style as at the Screening Visit 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)
- Be willing and able to cooperate with the requirements of the study.
- Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board.
- Be able to complete and understand the various rating instruments in English.
- -
Who cannot join
- Clinical diagnosis of alopecia areata or scarring forms of alopecia
- 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, 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.
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- 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 may interfere with the study treatment.
- A known history of depression or bipolar disease or any other condition that may impact the subject's participation in the opinion of the investigator.
- Recent utilization of low level lasers for hair growth.
- 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 that are known to potentially cause hair loss or affect hair growth, as determined by the Investigator.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of an Oral Nutraceutical Supplement With Standardized Botanicals in Males With Self-Perceived Thinning Hair and Loss
Hair loss study in men with self-perceived thinning hair and loss
- Conditions
- Hair Loss, Hair Thinning
- Being tested
- Oral Nutraceutical 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.
Oral Nutraceutical SupplementDietary supplement
Standardized Botanicals. Take 4 capsules by mouth daily with a meal
PlaceboDietary supplement
Placebo. Take 4 capsules by mouth daily with a meal
| Study group | Role | What they receive |
|---|---|---|
| Oral Nutraceutical Supplement | Active comparator | Not described Receives: Dietary Supplement: Oral Nutraceutical Supplement |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair counts
The change in vellus and terminal hair counts / average number of hairs (N/cm2) within 2 ROIs
Measured: Day 90, 180, 270, 360
Secondary outcomes (2)
Shaft Thickness
Measured: Day 90, 180, 270, 360
Hair density
Measured: Day 90, 180, 270, 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start15 Oct 2018
- Primary completion1 Mar 2021
- Study completion1 Jun 2021
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair LossStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeNova Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709563
- Sponsor's protocol ID
- HAIR 2018
- Status last verified
- May 2023
- First submitted
- 15 Oct 2018
- Last updated
- 16 May 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 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of an Oral Nutraceutical Supplement With Standardized Botanicals in Males With Self-Perceived Thinning Hair and Loss
- ClinicalTrials.gov ID
- NCT03709563
- Acronym / sponsor ID
- HAIR 2018
- Conditions
- Hair Loss, Hair Thinning
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 74 participants (actual)
- Lead sponsor
- DeNova ResearchUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 17 Oct 2018 (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.
Hair loss study in men with self-perceived thinning hair and loss
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Nutraceutical Supplement | Active comparator | Dietary Supplement: Oral Nutraceutical Supplement |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Males between 21-45 years of age, inclusive
- Have self-reported thinning or hair loss for more than 3 months prior to screening
- Clinically confirmed to have hair loss or thinning by the investigator via physical exam, including subjects with male pattern hair loss with frontal and vertex patterns II, IIIv or IV using the Norwood Hamilton Hair Loss Scale (NHS).
- In good general health, as determined by the Investigator
- Willing and able to attend all study visits
Key exclusion criteria (15 listed)
- Clinical diagnosis of alopecia areata or scarring forms of alopecia
- 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, 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.
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 |
|---|---|---|
| Oral Nutraceutical SupplementStandardized Botanicals. Take 4 capsules by mouth daily with a meal | Dietary supplement | Oral Nutraceutical Supplement |
| PlaceboPlacebo. Take 4 capsules by mouth daily with a meal | Dietary supplement | Placebo |
Primary outcome
Hair counts
Time frame: Day 90, 180, 270, 360
The change in vellus and terminal hair counts / average number of hairs (N/cm2) within 2 ROIs
2 secondary outcomes
Shaft Thickness
Time frame: Day 90, 180, 270, 360
Hair density
Time frame: Day 90, 180, 270, 360
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nutraceutical Supplement in people with Hair Loss and Hair Thinning, run by DeNova Research at 1 site 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 11 inclusion and 15 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 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: COVID-19). 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 counts (time frame: Day 90, 180, 270, 360). 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 16 May 2023.