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Study Shows Nonprescription LCD Topical Solution is More Effective than Prescription-Strength Calcipotriol Cream for Moderate Plaque Psoriasis
Date:3/10/2009

- Significant efficacy differences widen 6 weeks after treatment stops -

SAN FRANCISCO, March 10 /PRNewswire/ -- A nonprescription topical solution made with a new formulation of liquor carbonis distillate (LCD), known as PSORENT(R), is significantly more effective than prescription-strength calcipotriol cream in improving and controlling the symptoms of plaque psoriasis, according to research findings presented at the American Academy of Dermatology's 2009 Annual Meeting. Significant efficacy differences favoring LCD solution over a 12-week treatment phase were also pronounced after treatment stopped, during a 6-week regression phase that was the focus of the today's presentation. The research, a randomized, investigator-blind, active-controlled study of 60 adults with moderate plaque psoriasis, was conducted by a team of investigators at the Clinical Unit for Research Trials in Skin (CURTIS) at Massachusetts General Hospital in Boston, Massachusetts.

"We knew, based on the preliminary study results we presented at the summer AAD, that in the treatment phase of this study, twice-daily LCD outperformed calcipotriol cream for control of psoriasis symptoms," said Alexa Kimball, MD, MPH, a CURTIS researcher who was also a study investigator and author. "But we were encouraged by the fact that the improvements also persisted longer after patients stopped their twice-daily treatments for six weeks."

The team's conclusions are based on data from 55 patients who received treatment for up to 12 weeks and 43 patients who returned for re-assessment 6 weeks after treatment stopped. Its main findings include:

  • LCD therapy produced a significantly better reduction in psoriasis severity than calcipotriol therapy in 12 weeks based on PASI 50 (67% vs. 36%) and PASI 75 (37% vs. 0%) achievers and percent change in PASI (58% vs 37%) and PGA scores (P<0.05).
  • Significantly fewer LCD-treated patients than calcipotriol-treated patients regressed to initial disease severity within 6 weeks of stopping treatment (P</=0.005).
  • PASI scores and PGA scores worsened significantly after stopping calcipotriol therapy but not after stopping LCD therapy (P</=0.05).
  • Within 6 weeks of completing treatment, LCD-treated patients reported better control of a range of psoriasis symptoms -- including scaling/flaking, redness, skin texture, itch, overall appearance, and overall discomfort -- than calcipotriol-treated patients.
  • Patients' rated LCD solution and calcipotriol cream as comparable for convenience, irritation potential, and aesthetic attributes (e.g., staining, scent).

Dr. Kimball said their results should be important to a wide range of psoriasis patients because they indicate that this nonprescription therapy, "has a compelling efficacy and aesthetic profile." Psoriasis experts asked to comment on the study seem to agree on its significance.

"Because no single treatment is right for everyone, dermatologists are always looking for new ways to improve outcomes for their psoriasis patients," said Mark Lebwohl, MD, chairman of the Department of Dermatology at The Mount Sinai School of Medicine in New York. "The results of this trial suggest that LCD may be an appropriate treatment choice for psoriasis patients with mild or moderate disease."

Jerry Bagel, MD, Windsor Dermatology, said that "a new therapy that is easy for patients to use, cosmetically preferable, and that has greater proven efficacy than a prescription medication with the safety profile of an OTC, is certainly good news for psoriasis patients."

About PSORENT(R)

PSORENT(R) is a new leave-on topical solution that has the proven efficacy of a prescription medication but is available OTC. This aesthetically advanced, quick-drying, solution is highly effective, easy and pleasant to use, and may help increase patient satisfaction and compliance.

PSORENT(R) is supplied in 100 mL bottles fitted with a convenient "dab-on" applicator that allows patients to treat themselves without touching the medication or their plaques. PSORENT(R) is sold through physicians' offices and is available online at www.psorent.com.

About NeoStrata

PSORENT(R) is marketed by NeoStrata Company, Inc. Located in Princeton, NJ, NeoStrata 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.

More information is available at www.neostrata.com and www.psorent.com.

    Media contact
    Barbara Green
    NeoStrata Company, Inc.
    609-986-2971
    bgreen@NeoStrata.com


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