Patent update
https://patents.google.com/patent/EP3145490A1/en
"Clinical trials that were carried out further demonstrated a surprisingly higher efficacy of the products described herein in comparison with what is known, so as to make their use possible at concentrations markedly lower than those of already known products."
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Lotions, eventually, can also be dispensed from "spray no-gas", then propellant free, bottles.
Additionally, it is possible to administer liposomes by oral route after having them properly delivered in capsules of gelatine or other substances suitable for the purpose and known to the expert in the field.
Regardless of the selected pharmaceutical form, it is clear that all excipients and all tactics known to the technical formulator in order to ensure stability, storability, absence of contamination, etc. of the preparations will be employed."
"The present invention relates to pharmaceutical compositions for the treatment of alopecia, baldness, hair loss, also in postmenopausal women, and in general to promote hair regrowth"
"Experimental study
Patients of female and male gender characterized by massive hair reduction due to various causes, and also a small number of patients of female gender of postmenopausal age, reporting hair thinning, hair reduction and loss of hair strength were selected."
"Results
On day 7 : both group 1 and group 2 experience a reduction of hair loss, defined "substantial" by patients of group 1 and "modest" by those of group 2.
On day 20: in group 1 all the patients have stopped losing hair and report the presence of a substantial fuzz. In group 2 hair loss has stopped in 6 patients and fuzz, where present, is more modest (in terms of number/cm2) .
On day 45: in group 1, fuzz has grown markedly stronger and takes the colour and consistency of natural hair. In group 2, as expected, all the patients have stopped losing hair, but only some of them report a certain degree of regrowth, fuzz is very weak and not completely coloured yet.
On day 90: in group 1 all the patients report total disappearance of hair reduction areas that have been replaced by robust and shiny hair. In group 2 hair reduction is still visible, even if areas are all covered with thick fuzz.
On day 120: group 1 confirms results already seen at day 90. Group 2 continues improvement, even if in some patients of male gender the fuzz has not got the characteristics of strength and colour typical of hair yet.
During the whole phase of the study the patients' skin was regularly assayed by dermoscopy, highlighting an improvement of circulation. Additionally, treated skin did not display allergic or inflammatory reactions.
From the observations reported here, first of all, it can be inferred that the formulations object of the present invention are clinically efficient in:
· stopping hair loss; • promoting hair regrowth in areas with alopecia;
• strengthening and fortifying hair, bringing it back to its original state
both in male and female subjects with forms of hair reduction or actual alopecia due to different causes, and in menopausal women.
Formulations set up here additionally:
• do not contain potentially toxic substances or that may interfere with other active ingredients;
· are not irritating for the skin: even after long term application no evidence of irritation or inflammation was reported;
• are stable in time: analysis carried out on the content of the vials 30 days after preparation detects
· significant Ρζ values in terms of stability, particularly for formulations containing 2% or, better, 3% stearylamine
• an unchanged content of active substances enclosed in liposomes;
· can be stored at room temperature and in a ready-to- use form;
and, surprisingly
• act more quickly and more effectively: comparison tests clearly demonstrate that group 1 has a more rapid, more substantial improvement and, mainly, it involves all the patients as compared with group 2, treated with Lotion B.
Again, it should be recalled that Lotion B contains PGE1 and equol in 1:1 ratio, while Lotion A contains 30% less of active substance (DGLA) . This means that the findings of the present invention exert an unexpectedly superior effect than what known, at markedly lower concentrations of active substance."