I believe this kind of information should be free and my university proxy allow me to get the study for free so here the introduction/conclusion:
Background
An alternative to currently marketed topical minoxidil solutions is desirable.
Objective
To assess the efficacy and safety of a new 5% minoxidil topical formulation in a propylene glycol–free foam vehicle in men with androgenetic alopecia (Androgenetic Alopecia).
Methods
This was a 16-week, double-blind, placebo-controlled trial of 5% minoxidil topical foam (MTF) in 352 men, 18 to 49 years old. At week 16, 143 subjects continued on an open-label phase to collect 52 weeks of safety information on 5% MTF.
Results
At week 16 compared with baseline, there was a statistically significant increase in (1) hair counts in the 5% MTF group versus placebo (P < .0001) and (2) subjective assessment of improved hair loss condition (P < .0001) in the 5% MTF group versus placebo. The 5% MTF was well tolerated over a 52-week period.
Limitations
There was no collection of efficacy data beyond 16 weeks.
Conclusions
We believe that 5% MTF is a safe and effective treatment for men with Androgenetic Alopecia.
Abbreviations: AEs, adverse events; Androgenetic Alopecia, androgenetic alopecia; FDA, Food and Drug Administration; GPR, global photographic review; MPHL, male pattern hair loss; MTF, minoxidil topical foam; MTS, minoxidil topical solution; OTC, over the counter; PK, pharmacokinetic; TAHC, target area hair count
conclusion:
Delivery of topical medications into the scalp is challenging. To be effective, (1) a majority of the medication must be delivered to the scalp, and medication lost on the hair or surrounding skin must be minimized; (2) the drug must be readily released from the vehicle; and (3) the drug must penetrate either the epidermis/outer root sheath of the infundibulum and/or the follicular canal and the protective layers that surround the hair shaft. Moreover, to ensure compliance, the medication must be cosmetically acceptable, especially if it is to be used daily and long term. This means it should be quick to dry, nongreasy, and should not affect the integrity of the hair by making it dry or brittle. Ideally, the constituents of the vehicle should themselves be nonirritating and of low allergic potential.
Since 1997, 5% MTS has been available OTC. GPR documents hair growth in 54% to 62% of men with Hamilton-Norwood pattern IIIv, IV, and V after 48 weeks of 5% MTS.12 However, the novel foam vehicle utilized in this study appears to offer certain advantages over the solution vehicle, including the absence of propylene glycol (a potential irritant), the ability to limit spread beyond the intended application site, and less time to dry after application. Its enhanced cosmetic acceptability may also increase compliance with treatment, increasing the overall results with topical minoxidil. The mean increase at 16 weeks in both absolute TAHC and the change in TAHC relative to baseline was statistically significant (P < .001) between 5% MTF and placebo (20.9 vs 4.7 nonvellus hairs and 13.4% vs 3% total nonvellus hairs, respectively). Subjects on 5% MTF noted a mean 70.6% increase in hair growth versus 42.4% of subjects on placebo.
The incidence of pruritus with 5% MTF was 1.1% versus 6% seen in a separate trial of 5% MTS.12 Overall, the incidence of irritation seen at baseline actually decreased during the study with both the foam vehicle and 5% MTF.
We conclude that the new 5% MTF preparation is a safe and effective treatment for MPHL