Hair ThinningNCT07901062
Clinical Study to Evaluate the Impact of Nutraceutical Supplements in Participants With Self-Perceived Thinning Hair
A study testing Nutraceuticals (Prototype) in people with Hair Thinning, run by Unilever R&D at 1 site in United States.
Trial summary
The purpose of the study is to determine changes in biomarkers associated with hair loss and scalp microbiome with a novel botanical formulation Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hair Thinning
- What is being tested?
- Nutraceuticals (Prototype)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females of Fitzpatrick skin types I-V, and all hair types between 20-65 years of age with self-perceived thinning, confirmed by a dermatologist.
- Study population will be approximately 50% men and 50% women.
- Clinically confirmed to have hair thinning or loss by the investigator or qualified sub-investigator or qualified grader via physical exam, including only male participants with 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 or female participants with hair late patterns I-2, I-3, or I-4 on the Savin scale.
- Willing and able to adhere to the same dietary lifestyles, including not introducing new supplements or vitamins, 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.
Show all 10Show fewer
- Willing and able to attend all study visits and comply with the test product daily instructions.
- 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 to remove any twists, braids, cornrows, hair extensions prior to study visits.
- Willing and able to cooperate with the requirements of the study.
Who cannot join
- Individuals who are pregnant, planning a pregnancy, nursing, or within 1year post-partum.
- 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 of study participation.
- Individuals with a BMI<18 or BMI > 33.
- 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.
Show all 23Show fewer
- 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 participant 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 chemical to treat your hair (including but not limited to hair coloring, bleaching, chemical straightening or relaxers) during the study.
- Use of any anti-inflammatory (except 81mg baby Aspirin), immunosuppressant during the study.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 incretin-based therapy, such as a GLP-1 receptor agonist, within the 6 months prior to screening.
- 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).
- Men currently using, planning to use, or have used anabolic-androgenic steroids (testosterones). 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.
- Any participant who is using 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.
- 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 participant'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 participant at risk or interfere with their participation in the study or study results.
- Known history of or current iron deficiency, bleeding disorders or platelet dysfunction syndrome as well as participants receiving anticoagulant therapy.
- Use of any supplements, products, medications, or medicated shampoos that are known to potentially cause hair loss or affect hair growth, including but not limited to, ashwagandha, turmeric, and saw palmetto, as determined by the Investigator or qualified sub-investigator.
- Affiliations with the testing facility or sponsor.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Comprehensive Research Group
Minneapolis, Minnesota, 55413
Ellen Leahy, 612-781-3400, eleahy@crginc.org
About this study
Official title: Clinical Study to Evaluate the Impact of Nutraceutical Supplements on Biomarkers and Scalp Microbiome in Participants With Self-Perceived Thinning Hair
The purpose of the study is to determine changes in biomarkers associated with hair loss and scalp microbiome with a novel botanical formulation
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 an 8 week, single-center, open-label, prospective, interventional study evaluating a single hair supplement in adult male and female participants with self-perceived hair thinning as confirmed by a dermatologist.
- Conditions
- Hair Thinning
- Being tested
- Nutraceuticals (Prototype)
- Keywords
- hair thinning, biomarkers
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutraceuticals (Prototype)Dietary supplement
The study supplement (nutraceuticals prototype) is plant based and consists of a novel combination of plant-based ingredients
| 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. Receives: Dietary Supplement: Nutraceuticals (Prototype) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum IL-6 concentration
The change in serum IL-6 measured by immunoassay. Change from baseline will be calculated at weeks 4 and 8
Measured: 8 weeks
Secondary outcomes (3)
Targeted gene expression
Changes in punch biopsy (24 targeted gene expression) at week 8 compared to baseline, measured by quantitative reverse transcription polymerase chain reaction (RT-PCR, or targeted gene expression panel). Results are reported as fold change relative to baseline.
Measured: 8 weeks
Serum and plasma level biomarkers
Change in serum and plasma levels of the following biomarkers at week 4 and 8 compared to baseline: High sensitivity C reactive protein (HsCRP); Tumor Necrosis Factor-alpha (TNF-alpha); Apolipoprotein B (ApoB); Growth Differentiation Factor 15 (GDF-15); Insulin-like Growth Factor 1 (IGF-1); Lipopolysaccharide binding protein (LBP); Beclin-1, measured by immunoassay.
Measured: 8 weeks
Scalp microbiome
Changes in scalp microbiome at weeks 4 and 8 compared to baseline, from swab samples by 16S RNA gene sequencing (or shotgun metagenomics). Outcomes include changes in alpha diversity, beta diversity and relative abundance of key taxa.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start8 Oct 2026 (estimated)
- Primary completion3 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Model description
- 8 week, single center, single-arm prospective interventional study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Comprehensive Research Group, Inc.
- Responsible party
- Sponsor
- Investigators
- Tracy Baubie, Principal investigator, Comprehensive Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901062
- Sponsor's protocol ID
- NW-NG-02
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 28 Oct 2026
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Impact of Nutraceutical Supplements on Biomarkers and Scalp Microbiome in Participants With Self-Perceived Thinning Hair
- ClinicalTrials.gov ID
- NCT07901062
- Acronym / sponsor ID
- NW-NG-02
- Conditions
- Hair Thinning
- Keywords
- hair thinning, biomarkers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Comprehensive Research Group, Inc.
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 3 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 28 Oct 2026 (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 determine changes in biomarkers associated with hair loss and scalp microbiome with a novel botanical formulation
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 an 8 week, single-center, open-label, prospective, interventional study evaluating a single hair supplement in adult male and female participants with self-perceived hair thinning as confirmed by a dermatologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 8 week, single center, single-arm prospective interventional study
| Arm | Type | Receives |
|---|---|---|
| Nutraceutical Dietary Supplement | Experimental | Dietary Supplement: Nutraceuticals (Prototype)Nutraceutical Dietary Supplement capsules are comprised of primary and secondary ingredients, designed to restore hair health from the inside out. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females of Fitzpatrick skin types I-V, and all hair types between 20-65 years of age with self-perceived thinning, confirmed by a dermatologist.
- Study population will be approximately 50% men and 50% women.
- Clinically confirmed to have hair thinning or loss by the investigator or qualified sub-investigator or qualified grader via physical exam, including only male participants with 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 or female participants with hair late patterns I-2, I-3, or I-4 on the Savin scale.
- Willing and able to adhere to the same dietary lifestyles, including not introducing new supplements or vitamins, 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.
Key exclusion criteria (23 listed)
- Individuals who are pregnant, planning a pregnancy, nursing, or within 1year post-partum.
- 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 of study participation.
- Individuals with a BMI<18 or BMI > 33.
- 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 |
|---|---|---|
| Nutraceuticals (Prototype)The study supplement (nutraceuticals prototype) is plant based and consists of a novel combination of plant-based ingredients | Dietary supplement | Nutraceutical Dietary Supplement |
Primary outcome
Serum IL-6 concentration
Time frame: 8 weeks
The change in serum IL-6 measured by immunoassay. Change from baseline will be calculated at weeks 4 and 8
3 secondary outcomes
Targeted gene expression
Time frame: 8 weeks
Serum and plasma level biomarkers
Time frame: 8 weeks
Scalp microbiome
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Hair Thinning
Active, not recruiting
Evaluation of the Scalp Skin Care Effects of Premium Revitalizing Elixir and Topical 5% Minoxidil
Scalp Health, Alopecia
Enrolling by invitation
Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia
Androgenic Alopecia, Hair Loss/Baldness
Enrolling by invitation
Pilot Study to Evaluate the Efficacy and Safety of Xvie Delivered Into the Scalp by Microneedling in Women With Self-perceived Thinning Hair
Hair Thinning
Enrolling by invitation
Study Evaluating Xtressé Gummy Supplement in Women With Self-Perceived Thinning Hair
Hair Thinning
Active, not recruiting
Study to Evaluate Xtresse Serum in Individuals With Thinning Hair
Thin Hair, Hair Loss
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.
Tracy Baubie principal investigator
Comprehensive Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutraceuticals (Prototype) in people with Hair Thinning, run by Unilever R&D 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 10 inclusion and 23 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: opening soon, as of the sponsor's last update on 28 Oct 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Raymond, PhD (314-775-7688, Isabelle@nutrafol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum IL-6 concentration (time frame: 8 weeks). 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 28 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.