phase.18-20 Finasteride, an FDA-approved oral anti-androgen that inhibits type II 5-a-reductase activity, also promotes the anagen phase; however, the negative side effects attributed to DHT suppression such as erectile dysfunction and loss of libido are a cause of therapy withdrawal.21-24
Alternative options in topical treatments include herbal extracts,
which ideally function in an androgen-independent manner, and have demonstrated efficacy in stimulating hair growth with little side effect. A wide variety of herbal extracts used for centuries in traditional Ayurveda, Chinese, and Unani culture have demonstrated benefit in promoting fuller healthier-
looking hair as monotherapies and as adjunctive treatments to traditional hair loss treatments with fewer side effects.25,26
Other androgen-independent treatment options include platelet-
rich plasma (PRP) scalp injections, which are believed to stimulate development of new hair follicles and promote neovascularisation using the pro-healing cytokines released from blood platelets such as platelet-derived growth factor (PDGF), transforming growth factor (TGF), vascular endothelial growth factor (VEGF), insulin-like growth factor (IGF), epidermal
growth factor (EGF), and interleukin (IL)-1.27,28 Although the results seen with PRP treatment for hair growth are promising,
the long-term outcome has not yet been determined. In addition, low-level laser (light) therapy (LLLT) has been demonstrated
to promote hair growth in men and women with AGA, although the long-term effects of low-level laser treatment on hair growth and maintenance have not yet been determined.29 The most permanent treatment option, surgical hair transplantation,
is an invasive procedure that favors the subgroup of patients with dense hair in the donor site (occipital scalp) and focal hair loss in the frontal and mid-frontal scalp.30
For patients affected by AGA, there is no permanent cure and the degree of hair loss progresses over time. The effect of hair loss impacts self-esteem, psychosocial functioning, and quality of life. The mainstay of treatment options for men is the twice-daily use of topical minoxidil. Because microinflammation may contribute to AGA, and existing commercial preparations of minoxidil can be irritating to some patients, it is important to explore treatment options that are compatible with minoxidil and provide an anti-inflammatory effect.31 The need to explore additional safe and effective treatment options to supplement minoxidil monotherapy for AGA exists.
The treatment of AGA is long-term and requires patient adherence,
so exploration of novel treatment options should evaluate patient satisfaction in addition to efficacy. On this basis, the current
study evaluates the safety, efficacy, and subject satisfaction results with a topical regimen of topical minoxidil 5% foam used in combination with a botanical hair solution that may help promote
hair growth in men with AGA. Investigator ratings show that the regimen significantly improved scalp hair coverage and provided overall benefit in as few as 4 weeks. Subject self-ratings showed significant improvement in hair growth and hair appearance,
in as early as 4 and 6 weeks, respectively. The regimen was well tolerated, and subjects indicated a high degree of satisfaction.
METHODS
Participants
This clinical study protocol was reviewed and approved by an Institutional Review Board. At the baseline/screening visit, each participant’s written informed consent was obtained. Main inclusion criteria included: males aged 18 to 60 years with presence
of hair loss who exhibited MPHL/AGA (Norwood Scale III and IV), and a willingness to maintain the same hair style, color, and regimen throughout the study. Participants who had previously
used minoxidil were considered for inclusion, but were limited to no more than half of the participants.
Primary exclusion criteria included: use of concomitant hair loss therapies or medications; use of blood pressure medication;
