Clinical Trials
Two successful Phase I trials have been reported by Summit PLC. The first trial was described as a double-blind Phase I study in healthy volunteers using a single oral dose that showed up to a 70% reduction in sebum secretion. Prior to starting the second trial, Summit's director of clinical development Nigel Blackburn was quoted as saying:
The Phase I results are startlingly good. Reducing sebum production has been the "holy grail" of acne treatment for 30 years, and there has been little success aside from Roaccutane which has significant side effects.
and
At the doses we are looking at any side effects should be mild compared with those resulting from Roaccutane treatment'.
The second study was conducted using 18 healthy volunteers and examined the effect of repeat oral doses of SMT D002 over a four-day period. The key findings of the trial were reported as follows:
- Statistically significant levels of sebum suppression (primary endpoint) of 90% when compared to the placebo group (p=0.04)
- SMT D002 proved to be safe with no serious or unexpected adverse side-effects reported
- Sebum levels measured over six hours following treatment using a Sebumeter, an industry accepted method
- Results from trial support a previous positive Phase I single-dose study conducted in nine volunteers
Read more about this topic: SMT D002
Famous quotes containing the word trials:
“Without trials and tribulations, no one can become a Buddha.”
—Chinese proverb.