Placebo better than Phytopharm's P45 for alopecia in Phase II trials

In what came as something of a blow for the UK's plant-based drugs firmPhytopharm, Phase II clinical trial results on its P45, a topical cream developed from a medicinal plant for the treatment of alopecia (including male pattern baldness and alopecia areata and totalis) showed that there was a greater effect from placebo than from the product. P45 is derived from a family of Mediterranean lilies named drimea.

Following a randomized, double-blind placebo-controlled study at three centers in the UK, 75 patients were randomly assigned to apply either P45 or an inert placebo cream to the bald areas of their scalp once daily for 52 weeks. Only 24 completed the full trial. Of 69 evaluable patients (carrying forward the last score generated for those patients who dropped out of the study), using the primary efficacy measure of the investigator's assessment of hair re-growth, 29% of those treated with P45 were seen to have achieved positive results. However, a positive response was also reported for 38% of the placebo group.

The patients also provided their own assessment of response to treatment, which was reported to be favorable by 21% of subjects in both treatment groups. Possible treatment-related adverse events were recorded for 34% and 24% of the P45 and placebo group, respectively, though the majority of these were described as mild scalp reactions.