Effects of a Topical Serum Solution on Hair Characteristics

Overview

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.

Conditions

Interventions

Eligibility

Locations (3)

Outcomes