A Phase 2 Study of Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for the Treatment of Plaque Psoriasis

NCT00555646 Phase 2 TERMINATED

This is an open label, single center, controlled study with each subject's two treatment plaque areas assigned by the investigator 1:1 to (a) PH-10 with ambient light exposure and (b) PH-10 with 544 nm LED light illumination at 10 J/cm2. A third plaque area will receive no treatment and serve as a control. Subjects with at least three distinct, stable study plaque areas will receive the experimental therapy to two treatment plaque areas twice a week (2-5 days apart) for the lesser of 12 weeks or until remission is observed in the treatment plaque areas. If remission is observed in a treatment plaque area then treatment of that area will be discontinued and the area assessed weekly. A third plaque area (control plaque area) will receive no drug or light treatment and serve as an internal control. Primary efficacy will be assessed 12 weeks after initial PH-10 treatment. Subjects will be followed for a total of 16 weeks to allow assessment of Durability of Response of treated lesions and comprehensive follow-up of adverse events.

Details

Lead sponsor	Provectus Pharmaceuticals
Phase	Phase 2
Status	TERMINATED
Enrolment	6
Start date	2007-11
Completion	2008-09

Conditions

• Plaque Psoriasis

Interventions

• PH-10 (rose bengal disodium 0.001%)
• PH-10 (rose bengal disodium 0.001%)
• Control

Primary outcomes

• Treatment Success, defined as 0 or 1 on all Psoriasis Severity Index components (erythema, induration, and scaling) and 0 or 1 on the Plaque Response scale. — 12 weeks
  Treatment Success was assessed after 12 weeks and defined as 0 or 1 on all Psoriasis Severity Index components (erythema, induration, and scaling) and 0 or 1 on the Plaque Response scale.

Countries

United States