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news.Provectus Pharmaceuticals has reported a positive top-line data for PH-10 in the randomized controlled trial (RCT) conducted in psoriasis patients.
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The study compared safety and efficacy of three dose levels of PH-10 (0.002%, 0.005% and 0.01% Rose Bengal) against vehicle.
The Phase II trial had randomised ninety-nine patients to one of the four study arms and applied their assigned test article once daily for 28 consecutive days.
All the three efficacy parameters showed improvement in psoriasis symptoms over the treatment interval.
The low dose of PH-10 (0.002%) provided uniformly consistent improvement, while the two higher doses demonstrated reduced therapeutic activity.
Response for PH-10 at 0.002% Rose Bengal was comparable to that observed previously using PH-10 at 0.001% Rose Bengal, the study reported.
23-29% of subjects achieved complete or nearly complete resolution of all PSI component symptoms, after the treatment with all the strengths of PH-10, compared to no subjects in the vehicle arm.
Provectus CEO Craig Dees said the four-arm study clearly showed that the low dose level was optimal of the three doses tested, with similar activity to that seen in the earlier single-arm trial, and that it was superior to vehicle.