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NCT00555646 · ClinicalTrials.gov registry record · Phase 2
Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis
A Phase 2 study, sponsored by Provectus Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT00555646 is a Phase 2 study that was terminated before completion, run by Provectus Pharmaceuticals. The registered enrollment target is 6 participants.
The verdict
NCT00555646, a Phase 2 study, was terminated before completion, sponsored by Provectus Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study 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.
Interventions
- DRUG Control
- DRUG PH-10 (rose bengal disodium 0.001%)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2007-11 |
| Est. Completion | 2008-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00555646
The ClinicalTrials.gov registry entry for NCT00555646 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Provectus Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT00555646 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00555646 about?
NCT00555646 is a clinical study titled "Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis". 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 c...
What is the current status of trial NCT00555646?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2007-11. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00555646?
The interventions under investigation include: Control (DRUG), PH-10 (rose bengal disodium 0.001%) (DRUG).
Who is sponsoring clinical trial NCT00555646?
This trial is sponsored by Provectus Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
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