NCT00763503

Brief Summary

This is a multicenter, open-label study to assess systemic plasma levels of calcitriol, calcium homeostasis and safety in adults with plaque-type psoriasis under conditions of maximized use of CD 2027 3µg/g oily spray twice daily (6 g daily), applied to 20% of BSA for 3 weeks. There are a total of six visits: Pre-treatment period (Day -15, Day -8 and Day -1) and Treatment period (Day 1/ Baseline, Day 15 and Day 22).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 18, 2021

Status Verified

January 1, 2012

Enrollment Period

3 months

First QC Date

September 29, 2008

Last Update Submit

February 16, 2021

Conditions

Plaque-type Psoriasis

Keywords

psoriasisPKcalcitriol

Outcome Measures

Primary Outcomes (1)

  • CD 2027 plasma concentrations

    0, 1, 2, 3, 4, 6, 9, 12 hour time points

Secondary Outcomes (1)

  • Calcium homeostasis

    Screening, Day -8, -1 and prior to the morning application on Day 1, 15 and 22

Study Arms (1)

CD 2027

EXPERIMENTAL
Drug: CD 2027

Interventions

CD 2027DRUG

3µg/g Oily Spray

Also known as: Calcitriol
CD 2027

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of plaque-type psoriasis involving 10% - 20% of body surface area (BSA), with a Global Severity Score of at least 3 (moderate)

You may not qualify if:

  • Other type of psoriasis (other than plaque)
  • Significant abnormal lab findings
  • Secondary hyperparathyroidism
  • Vit D deficiency
  • Hypercalcemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Burke Pharmaceutical Research

Hot Springs, Arizona, 71913, United States

Location

DermResearch

Austin, Texas, 78759, United States

Location

J & S Studies

Bryan, Texas, 77845, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2008

First Posted

October 1, 2008

Study Start

September 1, 2008

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

February 18, 2021

Record last verified: 2012-01

Locations

US(3)