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

Galderma

Status and phase: Completed; Phase 2

Conditions: Plaque-type Psoriasis

Treatments: Drug: CD 2027

Study type: Interventional

Funder types: Industry

Identifiers

NCT00763503

RD.06.SPR.18118

Details and patient eligibility

About

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).

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

CD 2027

Experimental group

Treatment:

Drug: CD 2027