Efficacy Phase of Clinical Study Complete
Princeton, NJ — January 15, 2009 — NeoStrata today announced findings from a 12-week study that demonstrates significant clinical benefits of a novel topically applied LCD (coal tar) solution (Psorent™ psoriasis topical solution) versus calcipotriol cream (Dovonex®) in treatment of moderate plaque psoriasis. Specifically, results reveal the LCD solution outperformed calcipotriol cream in all efficacy measures including improvement of psoriasis symptoms (PASI 50, PASI 75, overall PASI and Physician Global Assessment) and is significantly faster in reducing patient-assessed redness/irritation and itch. Further, patient satisfaction with the aesthetics and ease of use of the LCD solution is high, with nearly 90% of patients rating the scent as acceptable and having an interest in continuing to use the medication after the study's completion.
The clinical data, from a trial conducted by investigator Alexa Kimball, MD, MPH, Massachusetts General and Brigham and Women's Hospitals, Boston, are being written into a research article for publication next year.
"These findings demonstrate the non-prescription LCD treatment outperformed a leading prescription medication thereby providing practitioners with a meaningful topical psoriasis treatment that is effective and well tolerated." said Dr. Kimball." Historically, tar has been considered unappealing due to its aesthetic profile, creating problems with patient compliance and overall satisfaction. This new formulation is aesthetically acceptable and was well-liked by the patients in the trial," added Dr. Kimball.
The 12-week study evaluated the safety and efficacy of the new topically applied 15% LCD against calcipotriol cream in treatment of 60 patients with moderate plaque psoriasis. The findings, representing final results for the 55 patients who had evaluable data, examined categorical and mean changes in PASI (Psoriasis Area Severity Index) improvement, as well as PGA (Physician's Global Assessment) scores and patient self-assessment. Findings include:
- LCD solution outperformed calcipotriol cream in the percent of patients achieving PASI 75 and PASI 50, as well as in overall improvement to PASI, all at a level of statistical significance, p<0.05.
- PGA scores versus baseline improved for both treatment groups over the 12-week study. At week 12, the LCD treatment group improved significantly more than the calcipotriol group, p<0.05.
- LCD solution reduced self-assessed redness/irritation and itch significantly faster than calcipotriol cream, p<0.05.
Barbara Green, VP, Technology & Clinical Affairs, NeoStrata, said the study confirms their excitement about the efficacy and aesthetic appeal of Psorent, available from physicians without a prescription. In fact, 100% of patients found Psorent™ psoriasis topical solution easy to use and nearly 90% said they would continue to use this treatment, citing that the dab-on applicator allowed them to apply the medication without touching the solution or their plaques. Patients also liked that the solution dried quickly, allowing them to get dressed soon after applying, and that this formulation reduced concerns of staining or mess.
"The excellent patient satisfaction revealed in this study validates our success in creating this new-generation topical psoriasis therapy," said Ms. Green. "We developed Psorent™ psoriasis topical solution to answer patient needs for clinical efficacy in an aesthetically pleasing non-prescription formulation that is different from the traditional coal tar experience. This formulation is quick-drying, has an acceptable scent, is easy to apply, and it works. We're very pleased that we've been able to advance coal tar into the 21st century," said Ms. Green.
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Data on File, NeoStrata Company, Inc.