Hair ThinningNCT05332743
Nutraceutical Supplement With Vegan Botanicals in Females With Self-Perceived Thinning Hair
A study testing Nutrafol Vegan Women's Hair Supplement in people with Hair Thinning, run by Nutraceutical Wellness Inc. at 2 sites in United States.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of a vegan nutraceutical supplement with standardized botanicals in females leading a more plant-based lifestyle with self-perceived thinning hair Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Thinning
- What is being tested?
- Nutrafol Vegan Women's Hair Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 May 2022to 23 Jun 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females of all Fitzpatrick skin, and hair types between 18-50 years of age with self-perceived thinning, confirmed by a dermatologist.
- Females leading a more plant-based lifestyle as of the last 3 months or longer according to the following categories: Vegetarian, Lacto-vegetarian, Ovo-Vegetarian, Lacto-ovo Vegetarian, Vegan, Raw Vegan, Pescatarian, Pollotarian, Flexitarian/Semi-Vegetarian
- Willing and able to adhere to the same dietary lifestyles for the duration of the study
- Able to understand and sign an informed consent agreement and photo release form approved by the Institutional Review Board
- 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.
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- Willing to maintain the same hair length, hairstyle, and coloring practices for the duration of the study. Subjects who have color-treated hair must have the color treatment performed at the same time interval prior to each visit.
- 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 are pregnant, planning a pregnancy, nursing, or within 1-year post-partum.
- 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.
- Individuals who have had a history of any acute or chronic disease that could interfere with or increase the risk on study participation
- Individuals who have had a history of any acute or chronic medical or hair condition that could affect study results, such as a history of disordered eating
- Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
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- Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis), infection, 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.
- Females who have recently (within the last 6 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study (the initiation of HRT or birth control should not have been associated with the initiation of hair loss/thinning).
- 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 or study results.
- 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
Integrative Skin Science and Research
Sacramento, California, 95815
About this study
Official title: A Multi-center, Single-arm Prospective Study to Evaluate the Safety and Efficacy of a Nutraceutical Supplement With Vegan Botanicals in Females With Self-Perceived Thinning Hair
The purpose of the study is to evaluate the safety and efficacy of a vegan nutraceutical supplement with standardized botanicals in females leading a more plant-based lifestyle with self-perceived thinning hair
Read the detailed description
Hair loss 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 loss 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.
This is a 6-month, multi-center, single-arm prospective interventional study in adult female subjects who follow a plant-based diet with self-perceived hair thinning as confirmed by a dermatologist. The objective of this study is to assess the efficacy and safety of novel women's vegan supplement for hair growth.
- Conditions
- Hair Thinning
- Being tested
- Nutrafol Vegan Women's Hair 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 Vegan Women's Hair SupplementDietary supplement
Nutrafol's Vegan Women's Hair Supplement with 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, Curcumin, Saw Palmetto, 20% Tocotrienol/Tocopherol complex, and capsaicin in combination with other vegan nutrients used to support hair health such as Pea Sprout Extract, Bamboo, and a new innovative Maldavian Dragonhead flower extract.
| Study group | Role | What they receive |
|---|---|---|
| Nutraceutical Dietary Supplement | Experimental | Nutraceutical Dietary Supplement capsules are comprised of primary and secondary ingredients, designed to restore hair health from the inside out. In addition to the necessary vitamins, minerals, proteins to support the nutritional needs of hair. Receives: Dietary Supplement: Nutrafol Vegan Women's Hair Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in terminal hair counts at Day 180 relative to baseline (Day 0)
Terminal Hair Counts
Measured: 180 Days
Secondary outcomes (5)
Change in total, terminal and vellus and hair counts compared to baseline (Day 0)
All Hair Counts
Measured: 180 Days
Change in Investigator Hair Quality Global Improvement Scale & Investigator Hair Growth Global Improvement Scale assessed by physician using standardized 2-D photographs compared to baseline.
Investigator Score using a 0 to 10 VAS scale
Measured: 180 Days
Hair shedding pull test compared to baseline.
Hair Pull Test
Measured: 180 Days
Subjective assessments of change in hair growth, appearance, and satisfaction measured with Subject Quality of Life Assessment
Subject self-assessments of satisfaction and perception using a 4-pt scale
Measured: 180 Days
Compiled side effects, including all expected or unexpected side effects
All side effects occurring during the study, categorized by severity (Mild, moderate, severe) and relatedness to the study product or participation
Measured: All visits until 180 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start19 May 2022
- Primary completion8 Jun 2023
- Study completion23 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- 6-month, multi-center, single-arm prospective interventional study
- Masking
- None (open label)
- Enrolment
- 110 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
- NCT05332743
- Sponsor's protocol ID
- NW-VW-01
- 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
Publications
Sivamani RK, Ablon G, Nong Y, Maloh J, Hazan A, Raymond I. A Prospective, Multi-Center Study to Evaluate the Safety and Efficacy of a Vegan Nutraceutical to Improve Hair Growth and Quality in Females Following a Plant-Based Diet. J Drugs Dermatol. 2024 Aug 1;23(8):661-668. doi: 10.36849/JDD.8421.
PubMed 39093662
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 Multi-center, Single-arm Prospective Study to Evaluate the Safety and Efficacy of a Nutraceutical Supplement With Vegan Botanicals in Females With Self-Perceived Thinning Hair
- ClinicalTrials.gov ID
- NCT05332743
- Acronym / sponsor ID
- NW-VW-01
- Conditions
- Hair Thinning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Nutraceutical Wellness Inc.Industry (pharma, biotech, devices)
- Study start
- 19 May 2022 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 18 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 purpose of the study is to evaluate the safety and efficacy of a vegan nutraceutical supplement with standardized botanicals in females leading a more plant-based lifestyle with self-perceived thinning hair
Detailed description
Hair loss 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 loss 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.
This is a 6-month, multi-center, single-arm prospective interventional study in adult female subjects who follow a plant-based diet with self-perceived hair thinning as confirmed by a dermatologist. The objective of this study is to assess the efficacy and safety of novel women's vegan supplement for hair growth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 6-month, multi-center, single-arm prospective interventional study
| Arm | Type | Receives |
|---|---|---|
| Nutraceutical Dietary Supplement | Experimental | Dietary Supplement: Nutrafol Vegan Women's Hair SupplementNutraceutical Dietary Supplement capsules are comprised of primary and secondary ingredients, designed to restore hair health from the inside out. In addition to the necessary vitamins, minerals, proteins to support the nutritional needs of hair. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Females of all Fitzpatrick skin, and hair types between 18-50 years of age with self-perceived thinning, confirmed by a dermatologist.
- Females leading a more plant-based lifestyle as of the last 3 months or longer according to the following categories: Vegetarian, Lacto-vegetarian, Ovo-Vegetarian, Lacto-ovo Vegetarian, Vegan, Raw Vegan, Pescatarian, Pollotarian, Flexitarian/Semi-Vegetarian
- Willing and able to adhere to the same dietary lifestyles for the duration of the study
- Able to understand and sign an informed consent agreement and photo release form approved by the Institutional Review Board
- General good health, as determined by the Investigator or qualified sub-investigator
Key exclusion criteria (19 listed)
- Individuals who are pregnant, planning a pregnancy, nursing, or within 1-year post-partum.
- 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.
- Individuals who have had a history of any acute or chronic disease that could interfere with or increase the risk on study participation
- Individuals who have had a history of any acute or chronic medical or hair condition that could affect study results, such as a history of disordered eating
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 Vegan Women's Hair SupplementNutrafol's Vegan Women's Hair Supplement with 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, Curcumin, Saw Palmetto, 20% Tocotrienol/Tocopherol complex, and capsaicin in combination with other vegan nutrients used to support hair health such as Pea Sprout Extract, Bamboo, and a new innovative Maldavian Dragonhead flower extract. | Dietary supplement | Nutraceutical Dietary Supplement |
Primary outcome
Change in terminal hair counts at Day 180 relative to baseline (Day 0)
Time frame: 180 Days
Terminal Hair Counts
5 secondary outcomes
Change in total, terminal and vellus and hair counts compared to baseline (Day 0)
Time frame: 180 Days
Change in Investigator Hair Quality Global Improvement Scale & Investigator Hair Growth Global Improvement Scale assessed by physician using standardized 2-D photographs compared to baseline.
Time frame: 180 Days
Hair shedding pull test compared to baseline.
Time frame: 180 Days
Subjective assessments of change in hair growth, appearance, and satisfaction measured with Subject Quality of Life Assessment
Time frame: 180 Days
Compiled side effects, including all expected or unexpected side effects
Time frame: All visits until 180 Days
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.
- Derived from this study: PubMed 39093662Sivamani RK, Ablon G, Nong Y, Maloh J, Hazan A, Raymond I. A Prospective, Multi-Center Study to Evaluate the Safety and Efficacy of a Vegan Nutraceutical to Improve Hair Growth and Quality in Females Following a Plant-Based Diet. J Drugs Dermatol. 2024 Aug 1;23(8):661-668. doi: 10.36849/JDD.8421.
- 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 Vegan Women's Hair Supplement 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 10 inclusion and 19 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. 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 at Day 180 relative to baseline (Day 0) (time frame: 180 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05332743, which also lists 1 linked publication.
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.