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Follica Positive Androgenetic Alopecia Study
Follica Positive Androgenetic Alopecia Study.
About this update from Puretech Health Plc
[{"type":"text","content":"\n \nRNS Number : 4045X PureTech Health PLC 19 December 2019 \n\n19 December 2019\nPureTech Health plc\n \nPureTech Health Affiliate Follica Announces Positive Topline Data from Clinical Study in Male Androgenetic Alopecia\n \nDemonstrated 44% improvement over baseline of visible (non-vellus) hair count, a well-established hair growth measure (p value < 0.001)\n \nStudy met primary endpoint and identified optimal frequency and number of treatments with Follica's proprietary device in combination with a topical drug after three months of treatment\n \nPhase 3 registration study initiation expected in first half of 2020\n \nPureTech Health plc (LSE: PRTC) (\"PureTech\") is pleased to note that its affiliate Follica today announced topline results from its safety and efficacy optimisation study to treat hair loss in male androgenetic alopecia. The study was designed to select the optimal treatment regimen using Follica's proprietary device in combination with a topical drug and successfully met its primary endpoint. The selected treatment regimen demonstrated a statistically significant 44% improvement of visible (non-vellus) hair count after three months of treatment compared to baseline (p < 0.001, n = 19). Across all three treatment arms, the overall improvement of visible (non-vellus) hair count after three months of treatment was 29% compared to baseline (p < 0.001, n = 48), reflecting a clinical benefit across the entire study population and a substantially improved outcome seen with the optimal treatment regimen. Additionally, a prespecified analysis comparing the 44% change in visible (non-vellus) hair count to a 12% historical benchmark set by approved pharmaceutical products1 established statistical significance (p = 0.005). The initiation of a Phase 3 registration study is expected in the first half of 2020.\n \nJoseph Bolen, PhD, chief scientific officer at PureTech, said: \"Currently, there are only two approved drugs on the market for the treatment of androgenetic alopecia, both of which have only demonstrated a 12% increase of non-vellus hair count over baseline. There remains a significant need for safe, effective, non-surgical treatments to grow new hair, and we believe the Follica data demonstrate strong promise as a potential new standard of care for the millions of pe...