SMT D002 - Clinical Trials

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

Other articles related to "clinical, clinical trials, trial, clinical trial":

List Of Clinical Research Topics - General Topics
... Clinical significance – a conclusion that an intervention has an effect that is of practical meaning to patients Drug discovery – the identification of candidates, synthesis, characterization, screening, and ... medical schools, academic hospitals, and universities) Clinical trials unit – biomedical research units dedicated to conducting clinical trials Epidemiology – the study of factors ...
Lloyd J. Old - Major Discoveries
... laboratory, thirteen have been licensed and seven are in clinical trials ... These include MORAb-003 (farletuzumab), currently in a phase III trial for ovarian cancer sponsored by Morphotek, which licensed the antibody from ... (RCC, kidney cancer), and is in phase III clinical trials as a diagnostic tool and as a therapeutic modality (also iodine-131-G250) ...
Synthes - Norian XR Scandal
... attorney in Philadelphia accused the company of running illegal clinical trials -- essentially, experimenting on humans ... a settlement with the state of New Jersey, over concerns that clinical investigators did not disclose their financial interests ... of shipping “adulterated and misbranded” products as part of unlawful clinical trials ...
Aaron E. Miller - Publications
... of a multiple sclerosis functional composite as a clinical trial outcome measure ... Clinical Features ... of three double-blind, randomized, placebo-controlled clinical trials ...

Famous quotes containing the word trials:

    On the whole, yes, I would rather be the Chief Justice of the United States, and a quieter life than that which becomes at the White House is more in keeping with the temperament, but when taken into consideration that I go into history as President, and my children and my children’s children are the better placed on account of that fact, I am inclined to think that to be President well compensates one for all the trials and criticisms he has to bear and undergo.
    William Howard Taft (1857–1930)