SEP 2018

MedEsthetics—business education for medical practitioners—provides the latest noninvasive cosmetic procedures, treatment trends, product and equipment reviews, legal issues and medical aesthetics industry news.

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Histogen launches fi rst U.S. clinical trial for its growth factor-based Hair Stimulating Complex with a focus on women's hair loss. Hair loss treatment products and services account for billions of dollars a year in consumer spending—a fi gure that belies the less-than-stellar effi cacy of most options, whether scalp treatments, minoxidil, red light therapy or platelet-rich plasma. "Whenever there are a lot of options it means there's not one single good option, and most current options require ongoing treat- ment or use," says Kimberly Butterwick, MD, of Cosmetic Laser Dermatology in San Diego, who is currently enrolling subjects for a new growth factor-based injectable hair loss treatment trial that, based on early studies, may fi nally break the mold by offering visible effi cacy with long-lasting results. Histogen's Hair Stimulating Complex (HSC660) is a soluble formulation of naturally secreted growth factors. In June 2018, the U.S. Food and Drug Administration (FDA) approved the company's Investigational New Drug (IND) application for HSC660. "All of our tissues and organs have stem cells, but over the course of our lives they lose their ability to regenerate due to aging, disease and injury. So although they are there, they are basically doing nothing," says Gail K. Naughton, PhD, founder and chief scientifi c offi cer of Histogen. Naughton developed HSC660 through her work trans- forming newborn fi broblasts to have the characteristics of multipotent stem cells. "Multipotent stem cells make a vari- ety of growth factors and chemical signals that are known to wake up stem cells in your body," she explains. By mimicking embryonic conditions of very low oxygen and suspension growth, she and her colleagues discov- ered they could convert newborn skin cells without any chemicals or genetic manipulation to become multipotent stem cells. "Under these conditions, a number of genes associated with stem cells are upregulated, including a gene called SOX21 that is very important for activation of hair growth," she says. "When we looked at the growth factors secreted by stem cells induced by low oxygen, we found that they, in fact, were very potent at stimulating the stem cells in a hair follicle, resulting in new hair growth." The company has completed three clinical trials outside of the U.S.—two for men and one that included both male and female subjects. This will be the fi rst U.S.-based trial and the fi rst to include only women. "I am excited about this trial because there are very few studies that have female subjects," says Dr. Butterwick. She is enrolling 27 female subjects between the ages of 40 and 70 years old with mild-to-moderate androgenic hair loss not caused by a scalp disorder or skin disease. Each will receive two sets of injections, one at week 0 and one at week 6. Eighteen will receive the active and nine a placebo. Outcomes will be measured by standardized photography, blinded physician evaluators and patient self-assessment. "Patients will also be monitored with bloodwork and urine samples," says Dr. Butterwick. Although this trial will focus on women, the company plans to fi rst seek approval for use in men. "We are most advanced with the male studies. We've already completed two company-controlled studies, and we are getting ready to fi le to begin the fi nal Phase 3 trial in men in Mexico," says Naughton, who notes that Histogen expects approval fi rst in Mexico and then in fi ve additional countries in Latin and South America. In North America, the company's goal is to conduct a Phase 2B dosing study in the next several months followed by a Phase 3 trial before the end of 2019. "We intend for the product to get approved fi rst in men, and then in women as we get additional data," says Naughton. "More than 30 million women struggle with hair loss right now," says Dr. Butterwick. "They can camoufl age it with wigs and patch products, but if there is a simple, off-the- shelf, in-offi ce treatment that offers long-lasting results, it will be very exciting." Inga Hansen is the executive editor of MedEsthetics. 64 SEPTEMBER 2018 | Med Esthetics NEWSMAKERS | By Inga Hansen © GETTY IMAGES HISTOGEN

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