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. The clinical efficacy of preparation 4 that on previous tests displayed the best characteristics of homogeneity and stability was evaluated .
Treatments :
Lotion A, prepared according to the present example 4 ; Lotion B, comparison, prepared as described in WO 2011/095938 (example 1) and then containing PGE1 and S- equol in 1:1 ratio
Lotion C, containing 7 mg of PGE1 enclosed in liposomes as the only active substance, prepared according to method A;
Lotion D, containing 1,25 mg of DGLA enclosed in liposomes as the only active substance, prepared according to method A.
Groups of patients:
• Group 1: 10 (6 male, 4 female) patients treated for 120 days with 1 ml/day of Lotion A to be applied on a well defined area of the scalp;
• Group 2: 10 (5 male, 5 female) patients treated for 120 days with 1 ml/day of Lotion B to be applied on a well defined area of the scalp;
• Group 3: 6 female menopausal patients for about 3 years, without specific diseases related to hair reduction, treated for 120 days with 1 ml/day of Lotion A to be applied on a well defined area of the scalp.
• Group 4: 4 (2 male, 2 female) patients treated for 120 days with 1 ml/day of Lotion C to be applied on a well defined area of the scalp; • Group 5: 4 (2 male, 2 female) patients treated for 120 days with 1 ml/day of Lotion D to be applied on a well defined area of the scalp;
Evaluation was carried out at pre-determined time points by dermoscopy and direct observation with photographic detections.
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. Group 3 feels hair as more robust. Groups 4 and 5 do not report any variation;
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) . Group 3 reports an aesthetic improvement related to hair brightness. Group 4 reports a minimal reduction in hair loss. Group 5 does not report any variation;
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. Group 3 reports disappearance of split ends. Group 4 reports arrested hair loss in all the subjects and, in some of them, presence of weak fuzz. Group 5 does not report any variation;
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. Group 3 confirms a general hair improvement. Groups 4 and 5 do not record variations from the previous evaluation;
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. Group 3 confirms results previously obtained. Groups 4 and 5 do not record variations from the previous evaluation
και οτι η πατεντα έχει αγοραστεί απο την Fidia που τωρα κανει δοκιμές (τελειώνουν τον Δεκέμβρη) και μαλλον θα κυκλοφορήσει το 2017.
