Clinical Studies

Clinical Experience - Acne Treatment

Results for Cutagenesis acne study at 6 week evaluation

Cutagenesis™ conducted a pilot study in 2006 on the effectiveness of the Cutagenix™ and Cutavive™ topical oxygen emulsions in acne treatment over a six-week trial period. This study was performed by a prominent dermatologist, yielding promising results by reducing the level of non-inflammatory acne lesions over a 6-week period.

The most valuable data in most acne studies is the blinded investigator acne lesion counts. This is the only truly accurate data and is used as the standard assessment in all prescription acne products being evaluated for FDA approval. The active and vehicle groups were well balanced in terms of lesion counts during baseline readings, so a fair assessment of each agent could be made. A decrease in both inflammatory and non-inflammatory acne counts was observed at week 6; analysis with a two-tailed t-test revealed a statistically significant decrease in noninflammatory lesions in the active group at p=0.05. There was a trend toward improvement with the active group in inflammatory lesion counts, but statistical significance was not reached (p=0.23) due to fewer overall lesions of this type in the subject population.

Figure 1 presents these data as the percent reduction in acne counts for both lesion types as compared to baseline; i.e., 100% reduction would represent 0 counts and complete resolution of the condition.

Figure 1: Results for Cutagenesis acne study at 6 week evaluation.

Results for Cutagenesis acne study at 6 week evaluation.

Both the oxygenated emulsion and vehicle groups experienced substantial acne count reductions at week 6, particularly in non-inflammatory lesions. The oxygenated emulsion outperformed the vehicle with respect to both lesion types – statistical significance was achieved in the non-inflammatory group with p < 0.05 and would be expected to reach significance with a higher total count of inflammatory lesions. Source: TherOx.

The eradication of noninflammatory acne is a significant benefit. The microcomedone is felt to be the precursor of all acne lesions, both inflammatory and noninflammatory. It is the microcomedone that is the site of action for the most potent group of topical anti-acne prescription medications, known as retinoids (Retin-A, Differin, Tazorac). If the oxygen-containing emulsion could be documented to be efficacious against noninflammatory acne in a large scale more definitive study, it would be a valuable adjunct to the dermatologic acne armamentarium.