One such early stage opportunity is a topical treatment to reduce cellulite, the condition characterised by dimpled skin. CRF100 - Cellulite Reduction Formula - is a topically applied cream comprising a well-characterised chemical species (an alkaloid) with Futura's highly efficient DermaSys® delivery system. The alkaloid is already used by a number of major cosmetics companies in the treatment of cellulite and its use, at levels sufficient to produce a physiological effect, is supported by a growing body of scientific literature.
In in vitro trials, CRF100 has been shown to achieve at least an eight-fold improvement in delivery of the alkaloid through the skin compared with a number of market leading comparator products. The Company believes that this enhanced permeation, delivered by the DermaSys® system, will result in a physiologically active dose of the alkaloid in the subcutaneous tissues, the target site for the treatment of cellulite.
In a study of CRF100, conducted in France by a specialist dermatological contract research organisation a total of 44 healthy females with mild cellulite took part in the randomised, double blinded and placebo controlled study with a treatment period of 14 weeks.
A statistically significant trend of improvement in cellulite was seen at the first review point after 28 days, compared with placebo. However, a relatively high incidence of dry skin was also seen in eight subjects receiving both the placebo and CRF100 test articles which resulted in these subjects being withdrawn from the study. That the effect was seen in both the placebo and CRF100 suggested that the base cream, which was used in the placebo and in CRF100, was responsible for the dry skin.
As a consequence of the dry skin the dosing regime was modified in the second and third months of the study on ethical grounds from twice a day to once a day. This had the effect of overcoming the dry skin problem since only one further subject was withdrawn for dry skin after the dosing regime was altered. However the 50% reduction in the level of CRF100 may have compromised any potential further improvements in cellulite reduction that could have resulted from longer term exposure to the original higher dose.
Professor Anthony Rawlings, a Visiting Professor at the London School of Pharmacy and scientific advisor to Futura, commented that if the rate of reduction in cellulite observed after one month had been maintained to the end of the study this would have resulted in a dramatic reduction in cellulite. In addition to the reduction in cellulite, a slimming effect (decreased hypodermal dermis) was also observed at the end of the study with the use of CRF100 compared with placebo.
To achieve the positive clinical effect seen in the first month of the study, we have since been working on a reformulation of the base cream and a new clinical study is now underway. The design is similar to the initial clinical study in that it will comprise around 40 healthy females with cellulite in a randomised, double blinded and placebo controlled study. Results from the study are expected to be available by September 2013.
It is intended that CRF100 will be a cosmetic product and will be licensed at an appropriate time to a major global company for commercialisation. A number of patent applications covering DermaSys® are in various stages of grant or prosecution and further applications may be considered pending the achievement of successful clinical outcomes.
We are evaluating further product opportunities for our proprietary delivery system DermaSys® with a range of other compounds.