Primary endpoints: Efficacy (density, hair thickness, cumulative hair),
treatment response rate
Secondary endpoints: Local tolerance, systemic safety
120 male patients:
– 3 injection sites, 1 shaved site per patient as reference
– Treatment group (96 patients)
• 48 treated with single injections (3 different doses)
• 48 treated with
repeat injections at day 1 and 91 (3 different doses)
– Placebo group (24 patients)
• 12 treated with single injection (carrier vehicle only)
• 12 treated with repeat placebo at day 1 and 91
– 288 treated data sites (Compared to 16 in Phase I)
– 72 placebo data sites
– Primary Institution: Charité-Universitätsmedizin, Berlin
Proposed Phase II Design
RCH-01Phase II Status
Advisory meetings with EU Regulators (Paul-Ehrlich-Institut):
• Product manufacturing presentation (Nov 2, 2012)
– Minimal changes - must add certain process validations protocols
• Clinical design presentation (Feb 2013)
– Feedback on proposed clinical treatment protocol
• Clinical trial application (Mid-2013)
• Ethics Review Board - Charité-Universitätsmedizin, Berlin (Mid-2013)
• Phase II trial initiation Mid-2013
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