Study of Dose-Effect of COL-121 Ointment in Patients With Plaque-Type Psoriasis

Recruiting in Palo Alto (17 mi)

+19 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Deltanoid Pharmaceuticals

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Michael Graeber, MD

Principal Investigator

Galderma R&D

Eligibility Criteria

Inclusion Criteria

Psoriasis must affect at least 2% and not more than 10% of the subject's body surface area, excluding the face and scalp

Subject must have 2 to 4 target plaques on the area to be treated, excluding the face and scalp.

Subjects who are women of childbearing potential must have a negative pregnancy test and be non-lactating.

Treatment Details

Interventions

• COL-121 Ointment (Vitamin D Analog)

Participant Groups

Group I: 75 µg/g COL-121 Ointment Experimental Treatment 1 Intervention

75 µg/g COL-121 Ointment

Group II: 300 µg/g COL-121 Ointment Experimental Treatment 1 Intervention

300 µg/g COL-121 Ointment

Group III: 150 µg/g COL-121 Ointment Experimental Treatment 1 Intervention

150 µg/g COL-121 Ointment

Group IV: 50 µg/g Calcipotriene Ointment Active Control 1 Intervention

50 µg/g Calcipotriene Ointment (active control)

Group V: Placebo Ointment Placebo Group 1 Intervention

Placebo Ointment

Who Is Running the Clinical Trial?

Deltanoid Pharmaceuticals

Lead Sponsor

Trials

5

Recruited

580+