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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: Completed Phase 2 study, sponsored by Deltanoid Pharmaceuticals.
NCT00625326 is a Phase 2 study that has completed, run by Deltanoid Pharmaceuticals. The registered enrollment target is 321 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (141% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00625326 record still lists
NCT00625326 is an interventional study that assigns participants to a tested intervention. The registered 321 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (141% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00625326 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00625326's enrollment target sits among peer trials
321 151st of 2000 higher than 1,849 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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