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| Descriptive Information Fields | |||||
| Brief Title † | Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis | ||||
| Official Title † | A Phase 2 Study of Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for the Treatment of Plaque Psoriasis | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label, Single Group Assignment | ||||
| Primary Outcome Measure † | 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Change in Pruritus of subject's treatment and control plaque areas using a self-assessment scale of 0-4. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Time to Remission (TTR) based on the (a) number of treatments and (b) days elapsed until Treatment Success is noted in each treatment plaque area. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Durability of Response based on plaque areas exhibiting Treatment Success that retain this level of response. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ] Adverse Experience. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ] |
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| Condition † | Plaque Psoriasis | ||||
| Intervention † | Drug: PH-10 (rose bengal disodium 0.001%) Drug: Control |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 25 | ||||
| Start Date † | November 2007 | ||||
| Completion Date | August 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00555646 | ||||
| Organization ID | PH-10-PS-21 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Provectus Pharmaceuticals | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Provectus Pharmaceuticals | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | November 7, 2007 | ||||
| Last Updated Date | March 21, 2008 | ||||