Hair CharacteristicsNCT07785869
Effects of a Topical Serum Solution on Hair Characteristics
A study testing Re:You Hair Revival Serum 1, Re:You Hair Revival Serum 2 and Topical Minoxidil 2% in people with Hair Characteristics, run by Pacagen, Inc. at 3 sites in 2 countries.
Trial summary
The purpose of this study is to assess changes in the characteristics of scalp hair among healthy female participants with mild to moderate hair loss, classified as Ludwig Scale I-3 to II-2 Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Hair Characteristics
- What is being tested?
- Re:You Hair Revival Serum 1, Re:You Hair Revival Serum 2 and Topical Minoxidil 2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 26 Jan 2026to 25 Sep 2026
- 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 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is female between 35 and 70 years of age;
- Participant has mild to moderate hair loss, classified as Ludwig Scale I-3 to II-2;
- Participant agrees not to use any hair products other than those required by the protocol (tonic, lacquer, gel, foam, etc.) until the end of the study;
- Participant agrees not to change their shampoo, conditioner, or shampooing frequency and maintain a consistent hairstyle for the duration of the study;
- Participant is willing to use only their regular, neutral mascara on their eyelashes and stop use of any other products on them for the duration of the study;
- Participant is willing to not substantially change their current diet, medications, multivitamins or supplement, or exercise routines for the duration of the study;
- Participant is in generally good health;
- Participant understands and has signed an Informed Consent Form in conformance with 21 CFR Part 50: "Protection of Human Participants."
Who cannot join
- Participant is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
- Participant wears a weave, extensions or dreadlocks or any other hairstyles that would interfere with the comb test;
- Participant exhibits irritation, tattoos, sunburn, rashes, scratches, burn marks, scarring, etc. on the test site, which might interfere with evaluations of test results;
- Participant is participating in another clinical study;
- Participant has used Minoxidil, Finasteride or any topical and oral supplements or other therapies (such as light therapy) known to prevent or promote hair growth within the past 3 months;
- Participant has been taking a stable dose of thyroid medication for a period of less than 4 months;
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- Participant has been taking a stable dose of GLP-1 (to manage diabetes or weight loss);
- Participant has been taking a stable dose of hormonal medication (testosterone/ estrogen/progesterone) for a period of less than 6 months;
- Participant has used any devices, prescriptions or OTC drugs that are known to affect the hair growth cycle within the past 6 months;
- Participant uses medications known to affect the hair growth cycle within the last months such as cyproterone acetate, aldactone/spironolactone, finasteride, or other 5-alpha-reductase inhibitors;
- Participant has received treatment with sympathomimetics, antihistamines, vasoconstrictors, non-steroidal anti-inflammatory agents, and/or systemic or topical corticosteroids within one month prior to initiation of the study;
- Participant has a history of acute or chronic dermatologic, medical, and/or physical conditions which would, in the opinion of the Principal Investigator, could influence the outcome of the study;
- Participant is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
- Participant has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
- Participant is currently undergoing treatment for active cancer of any kind;
- Participant has uncontrolled diabetes.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Eurofins Virginia Site
Forest, Virginia, 24551
Eurofins | CRL, Cosmetics LLC
Piscataway, New Jersey, 08854
China1 site
Eurofins Consumer Product Testing (Guangzhou) Co., Ltd.
Guangzhou, Guangdong, 510289
About this study
Official title: A Clinical Study to Evaluate the Efficacy of a Test Product to Change the Characteristics of Hair, Obtain Before and After Images and Obtain Consumer Perception of the Test Material Using Questionnaires
The purpose of this study is to assess changes in the characteristics of scalp hair among healthy female participants with mild to moderate hair loss, classified as Ludwig Scale I-3 to II-2
Read the detailed description
This study will include healthy female participants with mild to moderate hair loss of the scalp, classified as Ludwig Scale I-3 to II-2. Approximately 190 eligible participants will be enrolled to ensure 150 participants complete the study. Eligible individuals will be selected from the participating test facility's database of registered healthy volunteers. Participants will be randomized to use either Re:You Revival Hair Serum 1 (Product A), Re:You Hair Revival Serum 2 (Product B), or Topical Minoxidil 2% for 6 months using a computer-generated randomization table. Study participants will use the test product they have been randomized to daily for 6 months.
This study plans to assess whether daily application of a topical solution to the scalp for six months will improve hair characteristic like growth, retention, thickness, and scalp coverage, and whether daily application results in favorable consumer perception compared with baseline and the study control product.
The main purpose of the study is to assess global changes to scalp hair as graded by trained expert clinical graders, focusing on hair thickness/volume. Furthermore, each participant will perform a standardized comb test to determine the number of fallen hair after combing. Participants will also be asked to complete a questionnaire which assess their perception of hair characteristics and satisfaction with the test product they used during the study.
For a subset of participants digital imaging with software analyses of hair characteristics will be performed. The digital imaging software measures hair characteristics like hair density, hair thickness, target area hair coverage, and hair length.
Safety data will be collected throughout the study duration for each participant who received at least one application of test product.
In this study the per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment, completed the study in general accordance with the protocol, and have undergone expert clinical grading.
Study Rational: Approximately, 40% of women suffer from female pattern hair loss by the age of 55. Currently, there is only one drug approved by the US FDA for the treatment of female pattern hair loss (AGA) - topical minoxidil. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population is relatively low i.e., 30-40% re-grow hair.
Minoxidil is a pro-drug. To elicit a clinical response, minoxidil must be converted to its active form minoxidil sulfate by a sulfotransferase enzyme found in hair follicles. Individuals with low enzymatic activity experience little or no therapeutic benefit.
RE:YOU Hair Revival Serum is a non-drug, non-hormonal hair serum designed to support hair density, reduce visible shedding, and promote fuller-looking hair. The formula features proprietary NOVOGRO™ molecules designed to support multiple pathways associated with hair follicle and scalp environment health. These molecules support healthy hair follicle activity while helping maintain an optimal scalp environment to support stronger, thicker, and healthier-looking hair over time.
- Conditions
- Hair Characteristics
- Being tested
- Re:You Hair Revival Serum 1, Re:You Hair Revival Serum 2, Topical Minoxidil 2%
- Keywords
- Hair Characteristics, Hair Thickness, Topical Serum, Hair Care, Cosmetic Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re:You Hair Revival Serum 1Other
Also called Product A, ReYou Sample 1, Product 1
Participants apply 1 mL (equivalent to two dropperfuls) of Re:You Hair Revival Serum 1 once daily to the scalp for 6 months.
Re:You Hair Revival Serum 2Other
Also called Product B, ReYou Sample 2, Product 2
Participants apply 1 mL (equivalent to two dropperfuls) of Re:You Hair Revival Serum 2 once daily to the scalp for 6 months.
Topical Minoxidil 2%Drug
Also called OTC Product, Control, ReYou Sample 3, Product 3
Participants apply 2 mL (equivalent to two dropperfuls) of topical minoxidil 2% solution once daily to the scalp for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Re:You Hair Revival Serum 1 | Experimental | Not described Receives: Other: Re:You Hair Revival Serum 1 |
| Re:You Hair Revival Serum 2 | Experimental | Not described Receives: Other: Re:You Hair Revival Serum 2 |
| Topical Minoxidil 2% solution | Active comparator | Not described Receives: Drug: Topical Minoxidil 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in global scalp hair thickness/volume
Clinical grading of the thickness of the global scalp hair using a 0-9 scoring scale
Measured: Baseline, Day 180
Secondary outcomes (5)
Change from baseline in global scalp hair thickness/volume
Clinical grading of the thickness of the global scalp hair using a 0-9 scoring scale
Measured: Baseline, Day 90
Participant Perception
Self-administered perception questionnaire, consisting of up to 18 questions in the patient's language on treatment effect on hair characteristics, satisfaction with appearance, self-perceived stress levels, and confidence.
Measured: Baseline, Day 90, Day 180
Comb test
Hair in the target area will be combed onto a white paper for a total of 60 seconds. Hair that falls onto the white surface will be counted
Measured: Baseline, Day 90, Day 180
Subgroup analysis: Change from baseline in target area hair thickness
Thickness of the hair in the target area measured using digital imaging and software analysis. Hair thickness is reported in μm
Measured: Baseline, Day 90, Day 180
Adverse Events
Any undesirable experience associated with the treatment or the comparator in a study participant.
Measured: Through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start26 Jan 2026
- Primary completion25 Sep 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
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 CharacteristicsStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacagen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Zeng, Principal investigator, Eurofins Consumer Product Testing (Guangzhou) Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785869
- Sponsor's protocol ID
- ECRLNJ2025-0907
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Qu Z, Li Y, Cho SE, Doğan L, Yao Q, Tang L, Zhao G, Zhao EM, Li A, Omori S, Wong F, Zhang DKY. AI-enabled discovery of small molecules targeting complementary pathways for hair follicle rejuvenation. bioRxiv. June 12, 2026. doi: 10.64898/2026.06.09.728282.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Efficacy of a Test Product to Change the Characteristics of Hair, Obtain Before and After Images and Obtain Consumer Perception of the Test Material Using Questionnaires
- ClinicalTrials.gov ID
- NCT07785869
- Acronym / sponsor ID
- ECRLNJ2025-0907
- Conditions
- Hair Characteristics
- Keywords
- Hair Characteristics, Hair Thickness, Topical Serum, Hair Care, Cosmetic Product
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Pacagen, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 25 Aug 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 this study is to assess changes in the characteristics of scalp hair among healthy female participants with mild to moderate hair loss, classified as Ludwig Scale I-3 to II-2
Detailed description
This study will include healthy female participants with mild to moderate hair loss of the scalp, classified as Ludwig Scale I-3 to II-2. Approximately 190 eligible participants will be enrolled to ensure 150 participants complete the study. Eligible individuals will be selected from the participating test facility's database of registered healthy volunteers. Participants will be randomized to use either Re:You Revival Hair Serum 1 (Product A), Re:You Hair Revival Serum 2 (Product B), or Topical Minoxidil 2% for 6 months using a computer-generated randomization table. Study participants will use the test product they have been randomized to daily for 6 months.
This study plans to assess whether daily application of a topical solution to the scalp for six months will improve hair characteristic like growth, retention, thickness, and scalp coverage, and whether daily application results in favorable consumer perception compared with baseline and the study control product.
The main purpose of the study is to assess global changes to scalp hair as graded by trained expert clinical graders, focusing on hair thickness/volume. Furthermore, each participant will perform a standardized comb test to determine the number of fallen hair after combing. Participants will also be asked to complete a questionnaire which assess their perception of hair characteristics and satisfaction with the test product they used during the study.
For a subset of participants digital imaging with software analyses of hair characteristics will be performed. The digital imaging software measures hair characteristics like hair density, hair thickness, target area hair coverage, and hair length.
Safety data will be collected throughout the study duration for each participant who received at least one application of test product.
In this study the per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment, completed the study in general accordance with the protocol, and have undergone expert clinical grading.
Study Rational: Approximately, 40% of women suffer from female pattern hair loss by the age of 55. Currently, there is only one drug approved by the US FDA for the treatment of female pattern hair loss (AGA) - topical minoxidil. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population is relatively low i.e., 30-40% re-grow hair.
Minoxidil is a pro-drug. To elicit a clinical response, minoxidil must be converted to its active form minoxidil sulfate by a sulfotransferase enzyme found in hair follicles. Individuals with low enzymatic activity experience little or no therapeutic benefit.
RE:YOU Hair Revival Serum is a non-drug, non-hormonal hair serum designed to support hair density, reduce visible shedding, and promote fuller-looking hair. The formula features proprietary NOVOGRO™ molecules designed to support multiple pathways associated with hair follicle and scalp environment health. These molecules support healthy hair follicle activity while helping maintain an optimal scalp environment to support stronger, thicker, and healthier-looking hair over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Re:You Hair Revival Serum 1 | Experimental | Other: Re:You Hair Revival Serum 1 |
| Re:You Hair Revival Serum 2 | Experimental | Other: Re:You Hair Revival Serum 2 |
| Topical Minoxidil 2% solution | Active comparator | Drug: Topical Minoxidil 2% |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant is female between 35 and 70 years of age;
- Participant has mild to moderate hair loss, classified as Ludwig Scale I-3 to II-2;
- Participant agrees not to use any hair products other than those required by the protocol (tonic, lacquer, gel, foam, etc.) until the end of the study;
- Participant agrees not to change their shampoo, conditioner, or shampooing frequency and maintain a consistent hairstyle for the duration of the study;
- Participant is willing to use only their regular, neutral mascara on their eyelashes and stop use of any other products on them for the duration of the study;
Key exclusion criteria (16 listed)
- Participant is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
- Participant wears a weave, extensions or dreadlocks or any other hairstyles that would interfere with the comb test;
- Participant exhibits irritation, tattoos, sunburn, rashes, scratches, burn marks, scarring, etc. on the test site, which might interfere with evaluations of test results;
- Participant is participating in another clinical study;
- Participant has used Minoxidil, Finasteride or any topical and oral supplements or other therapies (such as light therapy) known to prevent or promote hair growth within the past 3 months;
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 |
|---|---|---|
| Re:You Hair Revival Serum 1Also: Product A, ReYou Sample 1, Product 1Participants apply 1 mL (equivalent to two dropperfuls) of Re:You Hair Revival Serum 1 once daily to the scalp for 6 months. | Other | Re:You Hair Revival Serum 1 |
| Re:You Hair Revival Serum 2Also: Product B, ReYou Sample 2, Product 2Participants apply 1 mL (equivalent to two dropperfuls) of Re:You Hair Revival Serum 2 once daily to the scalp for 6 months. | Other | Re:You Hair Revival Serum 2 |
| Topical Minoxidil 2%Also: OTC Product, Control, ReYou Sample 3, Product 3Participants apply 2 mL (equivalent to two dropperfuls) of topical minoxidil 2% solution once daily to the scalp for 6 months. | Drug | Topical Minoxidil 2% solution |
Primary outcome
Change from baseline in global scalp hair thickness/volume
Time frame: Baseline, Day 180
Clinical grading of the thickness of the global scalp hair using a 0-9 scoring scale
5 secondary outcomes
Change from baseline in global scalp hair thickness/volume
Time frame: Baseline, Day 90
Participant Perception
Time frame: Baseline, Day 90, Day 180
Comb test
Time frame: Baseline, Day 90, Day 180
Subgroup analysis: Change from baseline in target area hair thickness
Time frame: Baseline, Day 90, Day 180
Adverse Events
Time frame: Through study completion
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 25 Aug 2026.
- BackgroundQu Z, Li Y, Cho SE, Doğan L, Yao Q, Tang L, Zhao G, Zhao EM, Li A, Omori S, Wong F, Zhang DKY. AI-enabled discovery of small molecules targeting complementary pathways for hair follicle rejuvenation. bioRxiv. June 12, 2026. doi: 10.64898/2026.06.09.728282.
- Individual participant dataSharing planned: Yes
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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.
Sarah Zeng principal investigator
Eurofins Consumer Product Testing (Guangzhou) Co., Ltd.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re:You Hair Revival Serum 1, Re:You Hair Revival Serum 2 and Topical Minoxidil 2% in people with Hair Characteristics, run by Pacagen, Inc. at 3 sites in 2 countries.
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 8 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. 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, China. 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?
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 from baseline in global scalp hair thickness/volume (time frame: Baseline, Day 180). 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 NCT07785869, 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 25 Aug 2026.