Provectus has presented preliminary data for PH-10 Phase 2 clinical trial for psoriasis as well as for its Phase 2 clinical trial for atopic dermatitis.
According to the company, in the Phase 2 trial of PH-10 for psoriasis, preliminary data shows that 79% of 29 subjects in the clinical trial demonstrated improvement in the psoriasis scoring index (PSI) during four weeks of daily treatment with PH-10.
In addition, 83% of the subjects reported only mild pruritus (itching) by week four of the trial, with no significant safety issues noted.
The study was designed to assess the efficacy and safety of topical PH-10 applied once daily to psoriatic plaque areas. The study began in July 2009 and is expected to be completed by December 2009, with final data collection for primary outcome by February 2010.
In its Phase 2 trial of PH-10 for atopic dermatitis (eczema), preliminary data from the first 18 subjects indicated that 94% of subjects had improvement in the eczema area severity index (EASI) during four weeks of treatment.
As in the psoriasis study, the treatments were generally well tolerated with no safety issues identified.
PH-10 is an aqueous hydrogel formulation of Rose Bengal disodium for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis.
Craig Dees, CEO of Provectus, said: “We are excited by the positive data reported from both of the Phase 2 clinical trials for PH-10. As previously said, our development plans include seeking licensure of PH-10 for the treatment of serious dermatological diseases.”