Primary Endpoints at 6 months (interim analysis on 375 subjects) | Clascoterone 2.5% BID | Clascoterone 5% BID | Clascoterone 7.5% BID | Clascoterone 7.5% QD | Vehicle |
Mean changes from baseline TAHC | 13.0134 | 12.2109 | 20.7879 | 11.5182 | -0.1114 |
P value (vs. baseline) | < 0.0001 | < 0.0001 | < 0.0001 | < 0.0001 | 0.9660 |
P value (vs. vehicle) | 0.0003 | 0.0010 | < 0.0001 | 0.0017 | — |
Favorable HGA (+1, +2, +3) | 56% | 58% | 62% | 61% | 49% |
As a reference – these Phase 2 dose ranging interim results for TAHC for the 7.5% BID dose can be compared to the twelve-month TAHC results shown in the oral Propecia NDA – Clascoterone 7.5% BID reaches at six months the efficacy seen by oral Propecia. In the clinical study described in the NDA, Propecia (finasteride) 1 mg oral QD, attained a TAHC of 107 at twelve months treatment for a target area of 1-inch diameter circle (5.1 cm2). This compares to a TAHC in a 1cm2 area (as used in the Clascoterone study) of 20.1 (107 divided by 5.1) for Propecia compared to 20.8 for Clascoterone 7.5% BID. Furthermore, Cassiopea expects that the side effect profile of Clascoterone, a topical antiandrogen, will be much more favorable than that of an oral androgen modulator with its associated systemic side effects.
@marlin leggi cosa dice cassiopea nei risultati a 6 mesi, quel PP credo sia "per period", altrimenti i numeri rapportati a propecia non avrebbero alcun senso, finasteride a 1 anno non da il +107% ma + 107 capelli su pollice quadrato. (che poi dividono per 5 per trovare il cm2)