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NCT00625326 · ClinicalTrials.gov registry record · Phase 2
Study of Dose-Effect of COL-121 Ointment in Patients With Plaque-Type Psoriasis
A Phase 2 study, sponsored by Deltanoid Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 321
- Enrollment target
NCT00625326 is a Phase 2 study that has completed, run by Deltanoid Pharmaceuticals. The registered enrollment target is 321 participants.
The verdict
NCT00625326, a Phase 2 study, has completed, sponsored by Deltanoid Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 321 participants
- Enrollment target
Study Summary
Low doses of topically administered vitamin D analogs have been shown to have an anti-psoriatic effect without the risk of hypercalcemia. Calcipotriol, the most thoroughly studied of the vitamin D analogs, was first approved in Europe in the early 1990s. It has been shown to be comparable or slightly more effective than class II corticosteroid ointments. However, patients had reduced levels of parathyroid hormone; mean serum and urine calcium were increased during treatment and hypercalciuria was observed. These effects were reversible with discontinuation of therapy. Thus, while calcipotriol ointment was shown to be effective, the potential for alterations in calcium homeostasis have limited its use to 100 g of ointment per week (0.5 mg calcipotriol/week). Work has continued on the creation of new vitamin D analogs, such as COL-121, with the intent of eliminating the adverse effects of hypercalcemia and hypercalciuria with a compound that is more stable and more easily administered.
Interventions
- DRUG Placebo
- DRUG COL-121
- DRUG 50 µg/g Calcipotriene Ointment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 321 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00625326
The ClinicalTrials.gov registry entry for NCT00625326 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 321 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Deltanoid Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00625326 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00625326 about?
NCT00625326 is a clinical study titled "Study of Dose-Effect of COL-121 Ointment in Patients With Plaque-Type Psoriasis". Low doses of topically administered vitamin D analogs have been shown to have an anti-psoriatic effect without the risk of hypercalcemia. Calcipotriol, the most thoroughly studied of the vitamin D analogs, was first approved in Europe in the early 1990s. It has been shown to be comparable or slightl...
What is the current status of trial NCT00625326?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 321 participants. The study started on 2008-01. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00625326?
The interventions under investigation include: Placebo (DRUG), COL-121 (DRUG), 50 µg/g Calcipotriene Ointment (DRUG).
Who is sponsoring clinical trial NCT00625326?
This trial is sponsored by Deltanoid Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
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