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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: Clinical Trial Phase 2 study, sponsored by Provectus Pharmaceuticals.
NCT00555646 is a Phase 2 study that was terminated before completion, run by Provectus Pharmaceuticals. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
Why NCT00555646 stopped before completion
NCT00555646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT00555646 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00555646's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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