Effects of a Topical Serum Solution on Hair Characteristics

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

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.

Inclusion Criteria:

1. Participant is female between 35 and 70 years of age;
2. Participant has mild to moderate hair loss, classified as Ludwig Scale I-3 to II-2;
3. 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;
4. Participant agrees not to change their shampoo, conditioner, or shampooing frequency and maintain a consistent hairstyle for the duration of the study;
5. 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;
6. Participant is willing to not substantially change their current diet, medications, multivitamins or supplement, or exercise routines for the duration of the study;
7. Participant is in generally good health;
8. Participant understands and has signed an Informed Consent Form in conformance with 21 CFR Part 50: "Protection of Human Participants."

Exclusion Criteria:

1. Participant is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
2. Participant wears a weave, extensions or dreadlocks or any other hairstyles that would interfere with the comb test;
3. Participant exhibits irritation, tattoos, sunburn, rashes, scratches, burn marks, scarring, etc. on the test site, which might interfere with evaluations of test results;
4. Participant is participating in another clinical study;
5. 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;
6. Participant has been taking a stable dose of thyroid medication for a period of less than 4 months;
7. Participant has been taking a stable dose of GLP-1 (to manage diabetes or weight loss);
8. Participant has been taking a stable dose of hormonal medication (testosterone/ estrogen/progesterone) for a period of less than 6 months;
9. Participant has used any devices, prescriptions or OTC drugs that are known to affect the hair growth cycle within the past 6 months;
10. 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;
11. 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;
12. 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;
13. Participant is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
14. Participant has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
15. Participant is currently undergoing treatment for active cancer of any kind;
16. Participant has uncontrolled diabetes.