A Cross-Sectional Survey of Scalp Health Among Users and Non-Users of WEN

A CROSS-SECTIONAL SURVEY OF SCALP AND HAIR HEALTH AMONG USERS AND NON-USERS OF WEN BY CHAZ DEAN CLEANSING CONDITIONERS

Prepared for:

Prepared by:

June 3, 2020

A Cross-Sectional Survey of Scalp Health Among Users and Non-Users of WEN

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1. INTRODUCTION Cardno ChemRisk was asked by WEN By Chaz Dean (“WCD”) to conduct a comprehensive risk and safety assessment of the cosmetic product commonly known as WEN® by Chaz Dean Cleansing Conditioner (the “WEN Products”), and, specifically, whether the product causes hair loss and/or any other adverse dermal event, which evaluation was triggered by complaints and allegations that the WEN Products caused hair loss in a very small percentage of consumers. As part of this assessment, Cardno ChemRisk conducted a cross-sectional human study in conjunction with Dr. (a board certified Dermatologist and assistant clinical professor at the University of Southern California) to evaluate the skin and hair health among users of the WEN Products and non-users. A cross-sectional study is an observational study that measures the outcome and the exposures in study participants at the same time (Setia, 2016). Cross-sectional studies are used to estimate the prevalence of disease or other conditions among exposed and non-exposed individuals, and are useful for public health planning, monitoring, and evaluation. However, since exposure and outcome are evaluated at the same time point, cross-sectional studies are limited in their ability to fully assess causality, but nevertheless can be a useful source of datapoints to show potential trends or lack of trends. The specific aims of this study was to 1) assess personal history of hair loss by self-reported questionnaires and 2) evaluate hair and scalp health using non-invasive technique. Findings were stratified by users and non-users of the WEN Products.

2. METHODS The goal of this study was to recruit at least 10 volunteers for each of the two study groups (one being users of the WEN Products and the other being non-users of the WEN Products). Volunteers were recruited by email and local flyers, which detailed the study objective, protocol, product information, and study logistics. Informed consent (Appendix A) was completed by all participating individuals. The study protocol was reviewed and approved by an Institutional Review Board, which is an administrative body that protects the rights and welfare of human participants in research studies. Individuals were included or excluded from this study based on the following inclusion/exclusion criteria: Inclusion:

• Consenting individuals who reviewed the study protocol and completed a consent form • Adults over the age of 18 • Individuals who were existing users of the WEN Products • Individuals who were never users of the WEN Products

A Cross-Sectional Survey of Scalp Health Among Users and Non-Users of WEN

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that use of the WEN Products do not lead to increased prevalence of adverse events including inflammation, redness, sores, scarring, hair breakage, or hair loss.

5. REFERENCES Setia M. S. (2016). Methodology Series Module 3: Cross-sectional Studies. Indian journal of dermatology, 61(3), 261–264. doi:10.4103/0019-5154.182410