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OpenTrials
Completed

NCT Number: NCT00763503

Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of CD 2027 Spray in Adults With Plaque-type Psoriasis

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).

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Key information

Conditions

Plaque-type Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Burke Pharmaceutical Research, Hot Springs, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

CD 2027

Drug

3µg/g Oily Spray

Other names: Calcitriol

Primary outcomes

  1. CD 2027 plasma concentrations

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

Secondary outcomes

  1. Calcium homeostasis

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

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

Pharmacokinetic and Pharmacodynamic Study of CD 2027 3µg/g Oily Spray Applied Twice Daily for 3 Weeks Under Conditions of Maximized Use in Adults With Plaque-type Psoriasis

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Oct 1, 2008
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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