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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00625326

Public ClinicalTrials.gov record NCT00625326. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

A Phase II Study of the Dose-Effect of COL-121 Ointment in Patients With Plaque-Type Psoriasis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00625326
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Deltanoid Pharmaceuticals
Industry
Enrollment
321 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 2008 (Type not available)
Primary completion
Dec 2008 (Actual)
Completion
Jun 2009 (Actual)
Last update posted
Apr 27, 2011

2008 – 2009

United States locations

U.S. sites
20
U.S. states
14
U.S. cities
20
Facility City State ZIP Site status
East Bay Dermatology Medical Group Fremont California 94538 —
Dermatology Research Associates Los Angeles California 90045 —
Skin Surgery Medical Group, Inc. San Diego California 92117 —
Dermatology Specialists, Inc. Vista California 92083 —
Cherry Creek Research, Inc. Denver Colorado 80209 —
Longmont Medical Research Network Longmont Colorado 80501 —
The Savin Center, PC New Haven Connecticut 06511 —
International Dermatology Research, Inc. Miami Florida 33144 —
MedaPhase, Inc. Newnan Georgia 30263 —
Dermatology Specialists Louisville Kentucky 40202 —
Michigan Center for Skin Care Research Clinton Township Michigan 48038 —
Grekin Skin Institute Warren Michigan 48088 —
Academic Dermatology Associates Albuquerque New Mexico 87106 —
Northwest Cutaneous Research Specialists Portland Oregon 97210 —
Philadelphia Institute of Dermatology Flourtown Pennsylvania 19034 —
DermResearch, Inc. Austin Texas 78759 —
Dermatology Associates of San Antonio San Antonio Texas 78258 —
Dermatology Research Center Salt Lake City Utah 84124 —
The Education & Research Foundation, Inc. Lynchburg Virginia 24501 —
Premier Clinical Research Spokane Washington 99204 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00625326, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 27, 2011 · Synced Nov 10, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00625326 live on ClinicalTrials.gov.

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