Provectus initiates recruitment for phase 2 trial of rose bengal solution for psoriasis

Provectus Biopharmaceuticals announced it has begun recruiting for a phase 2 mechanism-of-action trial of PH-10, a 0.005% preparation of rose bengal, for the treatment of moderate-to-severe psoriasis.

“PH-10 has already been testing phase 1 and 2 studies and a total of 226 patients,” Eric Watcher, PhD, Provectus chief technology officer, said in a press release. “In this study, we are looking at possible changes in the immunologic, structural and hyperproliferative state of the skin in the target plaque and evidence of cellular atypia following PH-10.”

Watcher said the company plans to use these data to prepare PH-10 for approval as a topical anti-inflammatory non-steroidal agent for treating psoriasis and other inflammatory dermatoses.

Total study enrollment is expected to be 30 patients, according to the release. Patients will apply PH-10 vehicle daily for 28 consecutive daily, followed by active PH-10 daily for 28 consecutive daily, to plaque psoriasis areas on the trunk or extremities. Palms, soles, scalp, facial and interitriginous sites will be excluded.

Biopsies of one target plaque will be conducted at baseline and at days 29 and 64, with a 7-day interval between biopsy at day 29 at the end of vehicle application and commencement of application of active PH-10 on day 36, according to the release. Study data from each patient will then be evaluated for clinical and cellular response to active investigational agent.

The study’s estimated completion date is January 2016, with further information available online.

Reference: www.pvct.com.