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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00763503

Enrollment

Registered

2008-10-01

Start date

2008-09-30

Completion date

2009-02-28

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque-type Psoriasis

Keywords

psoriasis, PK, calcitriol

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).

Interventions

DRUGCD 2027

3µg/g Oily Spray

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
CD 2027 plasma concentrations	0, 1, 2, 3, 4, 6, 9, 12 hour time points

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026