REDUCED SKIN IRRITATION WITH TRETINOIN CONTAINING POLYOLPREPOLYMER-2,A NEW TOPICAL TRETINOIN DELIVERY SYSTEM - A SUMMARY OF PRECLINICAL AND CLINICAL INVESTIGATIONS

Novel tretinoin cream and gel formulations have been developed that in corporate polyolprepolymer-2, which is a material designed to help ret ain drug molecules in and on the skin when applied in topical vehicles . The results of preclinical and clinical investigations have confirme d the beneficial impact of such a vehicle on tretinoin tolerability. I n vitro studies with selected polyolprepolymer-containing formulations have reduced initial and cumulative tretinoin percutaneous penetratio n and guinea pig studies showed that the gel formulation containing po lyolprepolymer-2 caused less erythema and edema than did the correspon ding commercially-available tretinoin gel formulation. Human studies w ith tretinoin containing polyolprepolymer-2 have consistently demonstr ated a favorable tolerability profile when compared with commercially- available tretinoin. Use of the polyolprepolymer-2-containing tretinoi n formulation in human studies has resulted in reductions in peeling - a problem commonly associated with use of standard tretinoin formulat ions. These reductions in irritation have not been at the expense of e fficacy; acne clinical trial results indicate comparable effectiveness between tretinoin containing polyolprepolymer-2 and commercially-avai lable tretinoin.