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Study Reveals Novel LCD Solution Provides Significant Benefits Versus Calcipotriol In Treatment Of Moderate Psoriasis
Date:7/31/2008

Clinical Data Presented at American Academy of Dermatology Summer Meeting

PRINCETON, N.J., July 31 /PRNewswire/ -- NeoStrata today announced findings from an ongoing 12-week study that demonstrates benefits of a novel topically applied LCD (coal tar) solution (Psorent(TM)) versus calcipotriol cream (Dovonex(R)) in treatment of moderate plaque psoriasis. Specifically, results of an interim analysis reveal the LCD solution is outperforming calcipotriol cream in achieving improvement of psoriasis symptoms (PASI 75) and is significantly better in reducing redness/irritation at both the 2- and 12-week point. Further, patient satisfaction with the aesthetics and ease of use of the LCD solution is high, with nearly 90% of patients expressing 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 on display in a Scientific Poster at the Summer Academy Meeting of the American Academy of Dermatology (AAD), July 31 - August 3 in Chicago, IL.

"While coal tar is widely viewed as a very effective treatment for psoriasis, its historically unappealing aesthetic profile has created problems with patient compliance and reduced overall treatment satisfaction," said Dr. Kimball. "These findings demonstrate the non-prescription LCD treatment is at least as effective as a leading prescription medication. Further, they suggest the aesthetically pleasing formulation of the LCD treatment offers a much-needed alternative for safe, effective, easy-to-use topical drug therapy for mild to moderate psoriasis - a welcome tool in our armamentarium."

The 12-week study is evaluating 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 interim results for 48 patients, evaluate 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:

-- The LCD solution outperformed the calcipotriol cream in the percent of patients achieving PASI 75 (30%); no patients in the calcipotriol group achieved PASI 75, a statistically significant finding, p<0.05.

-- More patients using LCD solution (61%) achieved PASI 50 than patients using calcipotriol (40%), p>0.10.

-- PGA scores versus baseline improved for both treatment groups over the 12-week study. At week 12, the LCD treatment group improved 45% relative to baseline versus the calcipotriol treatment group at 29%, p=0.054.

-- The LCD solution reduced self-assessed redness/irritation, itch and burning significantly faster than the calcipotriol cream after 2 weeks, p<0.05, and was more effective at reducing redness/irritation at 12 weeks, p<0.05. Both treatments significantly reduced all graded parameters relative to baseline at weeks 4, 8 and 12.

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, 86% of patients said they would continue to use Psorent even after the study ends, 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.

"We developed Psorent to answer patient needs for a non-prescription topical psoriasis therapy that offers a different experience from traditional coal tar treatment -- a formula with similar or better efficacy to a leading prescription medication, that was quick-drying, had an acceptable scent and was easy to apply," said Ms. Green. "The excellent patient satisfaction revealed in this study validates our success in creating this new-generation topical psoriasis therapy that offers clinical efficacy in an aesthetically pleasing non-prescription formulation."

About NeoStrata

The NeoStrata Company, located in Princeton, NJ, develops and markets advanced therapeutic and cosmetic dermatological products through consumer outlets and physicians' offices in the United States and internationally through physicians' offices, pharmacies and spas. http://www.neostrata.com / http://www.psorent.com


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