Efficacy and Safety of Minoxidil 5% Foam in Combination With a Botanical Hair Solution in Men With Androgenic Alopecia

April 2016 | Volume 15 | Issue 4 | Original Article | 406 | Copyright © 2016

Terrence C. Keaney MD,a Hanh Pham MA,b Erika von Grote PhD,b and Matthew H. Meckfessel PhDc

aThe Washington Institute of Dermatologic Laser Surgery, Washington, DC
bNestle Skin Health (SHIELD), New York, NY
cGalderma Laboratories, L.P., Fort Worth, TX

Abstract

Androgenic alopecia (AGA) is the most common type of hair loss in men, characterized by hair miniaturization, hairline recession, and vertex balding. It affects approximately 50% of men, negatively affecting self-esteem and sociability. Topical minoxidil formulations are approved up to a 5% concentration for men, but patient adherence to treatment is challenged by gradual results that may be perceived as a lack of initial benefit. Herbal extracts, which are also believed to promote healthier-looking hair, have a long history of use in hair care formulations. The safety and efficacy of a twice-daily regimen of 5% minoxidil foam used in combination with a novel botanical hair solution was evaluated in a 12-week, multicenter, single-arm, open label study in 56 subjects with mild to moderate AGA. Assessments included investigator ratings of improvement and subject self-ratings of satisfaction. Investigator ratings indicated significant improvement in scalp hair coverage and perception of overall treatment benefit in as early as 4 weeks (P<.001). Subject self-ratings were significant for improved hair growth and hair appearance in as few as 4 weeks (P<.05). The regimen was well tolerated, and subjects indicated a high degree of satisfaction. Investigator and subject-assessed efficacy and subject satisfaction with this novel regimen provide clinicians with an effective treatment option for AGA that also provides a high level of patient satisfaction, which may help promote patient adherence to long-term treatment.

J Drugs Dermatol. 2016;15(4):406-412.

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INTRODUCTION

Male pattern hair loss (MPHL), also known as androgenic alopecia (AGA), is a progressive form of non-scarring hair loss with characteristic thinning/loss affecting the frontal, temporal, and vertex areas of the scalp.1,2 Diagnosis is made by clinical evaluation of the scalp and a thorough medical history evaluation.3 During the term of normal hair growth, 85% to 90% of the hair follicles are in a growth phase (anagen) which lasts for 2 to 7 years, and then they decelerate during a 2 to 3 week transition phase (catagen) when the hair follicle matrix cells associated with the dermal papilla (DP) undergo apoptosis (cell death). The remaining 10% to 15% of the hair follicles have progressed beyond anagen/catagen, into a rest phase (telogen). Telogen lasts for up to 3 months, and concludes with shedding of the hair shaft as growth of a new hair is initiated.4

Androgenic alopecia is characterized by the premature onset of catagen and a progressive shortening of the anagen phase. Over time this shift is reflected by accelerated hair shedding, a decreased ratio of terminal (long, thick, pigmented) hairs to vellus (short, thin, non-pigmented hairs), and an overall reduction in hair density.5,6 AGA in men is associated with a progressive hereditary increase in conversion of testosterone to dihydrotestosterone (DHT) by type II 5-a-reductase.7,8 When androgen receptors of the DP-associated cells are preferentially bound by DHT, absorption of vital nutrients is blocked and hair matrix cell proliferation becomes inhibited. This malnourishment is believed to trigger the premature onset of catagen, cell apoptosis, and progressive shortening of the anagen phase.9-11 Microinflammation and altered prostaglandin metabolism within the hair follicle are also believed to contribute to premature DP apoptosis and follicular miniaturization by causing fibroplasia of the dermal sheath surrounding the hair follicle.12

Androgenic alopecia is the most common form of alopecia and is estimated to affect half of all men in the United States.13 Typical onset occurs between 30 and 40 years of age, and by the age of 70 years up to 85% of men may be affected.13,14 Although hair loss is primarily a cosmetic concern, hair contributes to outward appearance and social confidence, and patients seeking treatment for AGA are motivated by the psychological distress and negative impact that hair loss has on self-esteem and social self-confidence.15 Currently, topical minoxidil (2% solution and 5% solution or foam) and oral finestramide (1mg) are the only US Food and Drug Administration (FDA)-approved medications for the treatment of male AGA.16,17 Minoxidil’s mode of action is androgen independent, and believed to promote hair growth by promoting the production of vascular endothelial growth factor, increasing the production of anti-inflammatory prostaglandin E2 (PGE2), and lengthening the duration of the anagen

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