Any further news on this? Phase III? Results from IIB?
Phase IIB results are due in april
But aren't they just doing another 3 month +45 days post discontinuation? Or did they keep patients from the pervious trial and continued another 3 months? I get that we will see biopsies but I don't see how the results could be any different with the same amount of treatment time. Correct me if I'm missing something
Primary Outcome Measures:
Change in number of terminal hair follicles [ Time Frame: Baseline and Day 91 ] [ Designated as safety issue: No ]
Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of terminal hair follicles over the treatment period.
Change in number of anagen hair follicles [ Time Frame: Baseline and Day 91 ] [ Designated as safety issue: No ]
Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of anagen hair follicles over the treatment period.
Change in number of telogen hair follicles [ Time Frame: Baseline and Day 91 ] [ Designated as safety issue: No ]
Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of telogen hair follicles over the treatment period.
Change in number of catagen hair follicles [ Time Frame: Baseline and Day 91 ] [ Designated as safety issue: No ]
Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of catagen hair follicles over the treatment period.
Change in number of vellus (vellus-like) miniaturized hair follicles [ Time Frame: Baseline and Day 91 ] [ Designated as safety issue: No ]
Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of vellus (vellus-like) miniaturized hair follicles over the treatment period.
Change in number of indeterminate hair follicles [ Time Frame: Baseline and Day 91 ] [ Designated as safety issue: No ]
Scalp biopsies obtained prior to initiating therapy and after 90 days of therapy will be compared to determine the change in number of indeterminate hair follicles over the treatment period.
Ah well it will be interesting to see if the results are similar, worse or better, I think that if they are similar that would be interesting.https://clinicaltrials.gov/ct2/show/NCT02503137?term=Samumed&rank=3
They did a biopsy prior to and will do a biopsy after trial period.
Main differences as far as I can see is that they will get a better understanding of hair phases before and after treatment. In the first study, the primary goals were vellus/non-vellus hair count.
In the phase IIb:
Ah well it will be interesting to see if the results are similar, worse or better, I think that if they are similar that would be interesting.
Suddenly most of you guys have neglected SM while the result is not as bad as you interprete. SM has shown efficiency in as short as THREE months and you guys expect the result to be better than hair transplant in less than 12 months which is the general period length given to hair transplant, how funny it is.
When will their phase IIb come out?