Clinical Efficacy of a Cosmetic Treatment by Crescina® Human Follicle Stem Cell on Healthy Males with Androgenetic Alopecia

Daniela Buonocore 0 1 Vincenzo Nobile 0 1 Angela Michelotti 0 1 Fulvio Marzatico 0 1 0 V. Nobile A. Michelotti Farcoderm Srl European Expertise Network for Wellness and Dermatology, via Mons. Angelini 21, 27028 San Martino Siccomario, Pavia, Italy 1 D. Buonocore (&) F. Marzatico Laboratory of Pharmaco-Biochemistry, Nutrition and Nutraceutical of Wellness, Department of Biology and Biotechnology ''L. Spallanzani ,'', University of Pavia , via Ferrata 9, 27100 Pavia, Italy Introduction: Androgenetic alopecia (AGA) is the most common cause of hair loss among males, characterized by progressive thinning of the scalp hairs and defined by various patterns. The main factors underling hair loss in AGA are genetic predisposition and increased sensitivity of the hair follicles to androgens, leading to a shortening of the anagen phase. In the present study, the authors investigated the efficacy of a commercially available cosmetic lotion, Crescina HFSC (human follicle stem cell; Labo Cosprophar AG, Basel, Switzerland), in promoting hair growth and in decreasing hair loss. Methods: A placebo-controlled, randomized trial was carried out on healthy males suffering from alopecia grade II to IV. Anagen rate and hair resistance to traction (pull test) were assessed after 2 and 4 months of treatment using phototricogram and pull test technique. Results: Crescina HFSC applied for 4 months was effective in promoting hair growth and in decreasing hair loss. After 2 and 4 months of treatment, the anagen rate was increased by 6.8% and 10.7%, respectively. Hair resistance to traction was decreased by 29.6% and 46.8%, respectively. Conclusions: The present study demonstrated the positive effect of Crescina HFSC in modulating the activity of the hair follicle and promoting hair growth. - INTRODUCTION Androgenetic alopecia (AGA) is the most common cause of hair loss among males [1]. It is characterized by progressive thinning of the scalp hairs, defined by various patterns [2], which can start at any age after puberty and is potentially reversible. Even if from a medical point of view, AGA is considered a relatively mild condition; however, people suffering from this condition consider AGA a serious condition that impacts their selfesteem, well-being, social relationships, and confidence. The main factors underling hair loss in AGA are genetic predisposition and increased sensitivity of the hair follicles to androgens [3]. AGA is often precipitated and exacerbated by conditions that can induce telogen effluvium, including drugs, acute stressors, and weight loss [4]. However, in recent years it has been shown that other factors, such as microinflammation [5], decreased microcirculation [6], and aging [7], can cause hair loss in AGA. These changes contribute to shifting the normal balance of the hair cycle leading to a shortening of the anagen phase. The major components of balding in AGA are frontotemporal recession and loss of hair over the vertex. Hairs become shorter and finer, and finally complete hair loss occurs except at the lateral and posterior margins of scalp, where hair is retained. Histologically, in AGA large terminal follicles diminish in size during hair cycles, and the resulting miniaturized follicle eventually produces a microscopic hair. Testosterone is necessary for miniaturization, and 5-alphareductase inhibitors, which block the conversion of testosterone to its more active form dihydrotestosterone (DHT), delay the progression of AGA [8]. Recently, Garza and coworkers [9] reported the preservation of stem cell population and a decreased conversion of hair follicle stem cells to progenitor cells in bald scalp biopsies from AGA individuals. This finding is consistent with the current clinical concept that AGA is a nonscarring type of alopecia and suggests potential reversibility of the condition. Currently, only two medications, based on finasteride and minoxidil as active pharmacological ingredients, are approved by the US Food and Drug Administration (FDA) for AGA treatment. However, they are costly, require lifelong treatment, and may have side effects. Furthermore, people are frequently reluctant/ intimidated by the pharmacological approach to treat a disease that is not life threatening. Thus, a topical, nonpharmacological, effective cosmetic treatment could be more acceptable to patients. The aim of the present study was to assess the efficacy of the use of a patented (US 6,479,059 B2 and CH 703 390), topical cosmetic product, Crescina HFSC (human follicle stem cell; Labo Cosprophar AG, Basel, Switzerland), claimed to be effective for the treatment of male AGA [10]. The active ingredients contained in the product were chosen to obtain three main effects: proliferation of the stem cells of both the bulge and the dermal papilla, keratinization, and stimulation of microcirculation. Stem cell and dermal papilla stem cell proliferation was achieved by hydrolyzed rice protein and corosolic acid, respectively. Keratinization was stimulated by cysteine, lysine, and a glycoprotein (lectin). Microcirculation was stimulated by benzyl nicotinate. The mentioned results were obtained from studies commissioned by the company Labo Cosprophar AG, which has filed a patent (CH 703 390 B1) [10]. MATERIALS AND METHODS All the study procedures were carried out according to World Medical Associations (WMA) Helsinki Declaration and its amendments (Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amendments). To participate in the study, each participant was fully informed on study risks and benefits, aims, and procedures. An informed consent form and a consent release for publication of photos were signed by the subject prior to participating in the study. Subjects and Study Design Healthy male volunteers suffering from alopecia grade II to IV according to the Hamilton Norwood scale [11] (Fig. 1) were enrolled in the study. Subjects were enrolled in the study by a certified dermatologist if they fulfilled the inclusion and exclusion criteria laid down in the study design (Table 1) were applicable. Clinical examination was carried out in order to evaluate the degree and pattern of hair loss, and hair (length, diameter, and breakage) and scalp (inflammation, erythema and, scaling) conditions. Active and placebo treatments were then allocated by means of the Efrons biased coin algorithm using PASS 11 (version 11.0.8 for Windows; PASS, LLC., Kaysville, UT, USA). The tested and the placebo products were used for 4 months according to the following procedure: apply one vial (5 mL) of the product on clean and dry scalp, line by line, concentrating on the areas where thinning is more evident; massage gently to aid penetration; apply every day for 5 consecutive days, stop the treatment for 2 days and then continue the application. Fig. 1 HamiltonNorwood classification Tested Product The tested product (...truncated)