Phosphagenics beats market leader in acne trial
Phosphagenics (ASX:POH) said a formulation of tretinoin produced using the company’s Targeted Penetration Matrix (TPM) technology demonstrated key advantages over the market-leading product during an acne trial.
The phase II, randomised, active and vehicle controlled, investigator blind trial compared TPM/Tretinoin gel with market-leading topical formulation Retin-A (for which tretinoin is an active ingredient) and a vehicle containing TPM alone.
It evaluated 53 patients in Australia and New Zealand with mild to moderate acne vulgaris. The trial evaluated the reduction in acne lesions from baseline and the percentage of patients with a successful outcome on the Investigator’s Global Assessment score after 12 weeks’ treatment.
Results show that the TPM/Tretinoin formulation produced the highest mean reduction in the number of active inflammatory and non-inflammatory lesions at 76.6, compared to 68.9 for Retin-A.
There was no significant difference between treatment groups in the number of patients that had a successful outcome on the IGA scale - defined as a two-point reduction in score. But 70% of patients treated with TPM/Tretinoin showed a 1- or 2-point reduction in score, compared to 42% of Retina-A controls.
Interestingly, the TPM vehicle control demonstrated a degree of efficacy that exceeds the typical positive effects of vehicles used in acne reduction studies - as a result of the vigorous cleaning regime required of patients enrolled in such trials.
Phosphagenics said the TPM vehicle’s performance may be attributable to the enhanced vitamin E properties of the formulation, and that the technology has shown inherent acne-reducing properties in prior trials and in related approved Acne product Vital-ET.
“The results of this study are very encouraging considering the relatively small number of patients, and confirm that tretinoin when combined with our TPM formulation produced directional trends indicative of better performance than Retin-A against inflammatory lesions in particular,” Phosphagenics Director Dr Geert Cauwenbergh commented.
“This seems to be a result of our TPM technology, which is corroborated by effects seen in the vehicle formulation containing TPM.”
Phosphagenics (ASX:POH) shares were trading unchanged at $0.085 as of around 12.30 pm on Tuesday.
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