Clinical trial NCT00763555: Efficacy and Safety Study of CD 2027 Spray in Subjects With Plaque-type Psoriasis
Official title: A Multicenter, Randomized, Vehicle-controlled, Efficacy and Safety Study of CD2027 3µg/g Oily Spray Applied Twice Daily for 8 Weeks in Subjects With Plaque-type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: psoriasis
spray
calcitriol
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2008-10-01
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a multicenter, randomized, vehicle-controlled, double-blind parallel group study to evaluate the efficacy and safety of CD 2027 Oily Spray applied twice daily for 8 weeks in participants with plaque-type psoriasis.


Eligibility criteria: Inclusion Criteria:

* Participant has a diagnosis of plaque-type psoriasis up to 20% of body surface area (BSA) involved excluding the scalp, with a Global Severity Score of at least 3 (moderate) at Screening
* Participant presents with a representative target lesion that is at least 16 cm² in area, is located on the non-bony areas of the skin, has a Scaling Score up to 2 (moderate), has a DSS of at least 4

Exclusion Criteria:

* Other type of psoriasis (other than plaque)
* Significant abnormal lab findings
* Hypercalcemia

Primary outcomes:
measure: Percentage of Participants With Success Rate 1 (SR1) at Week 8
timeFrame: Week 8
measure: Percentage of Participants With Success Rate 2 (SR2) at Week 8
timeFrame: Week 8
measure: Change From Baseline in Dermatologic Sum Score (DSS) at Week 8
timeFrame: Baseline, Week 8
measure: Percentage of Participants With at Least 1-Grade Improvement From Baseline in Erythema, Scaling and Plaque Elevation
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: up to Week 8
measure: Percentage of Participants With a Local Tolerability Score Worse Than Baseline Score
timeFrame: up to Week 8
measure: Change From Baseline in Calcitriol Plasma Levels
timeFrame: Baseline, Week 8
measure: Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin
timeFrame: Baseline, Week 8
measure: Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin-adjusted Calcium
timeFrame: Baseline, Week 8
measure: Change From Baseline in Serum Calcium Homeostasis Parameter: Calcium
timeFrame: Baseline, Week 8
measure: Change From Baseline in Serum Calcium Homeostasis Parameter: Phosphorus
timeFrame: Baseline, Week 8
measure: Change From Baseline in Serum Calcium Homeostasis Parameter: Parathyroid Hormone (PTH) Intact
timeFrame: Baseline, Week 8
measure: Change From Baseline in Blood Chemistry: Alkaline Phosphatase, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)
timeFrame: Baseline, Week 8
measure: Change From Baseline in Blood Chemistry: Bilirubin Direct, Bilirubin Total, Blood Urea Nitrogen (BUN) and Creatinine
timeFrame: Baseline, Week 8
measure: Change From Baseline in Vital Sign Parameter: Heart Rate
timeFrame: Baseline, Week 8
measure: Change From Baseline in Vital Sign Parameter: Systolic Blood Pressure and Diastolic Blood Pressure
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Edmonton
country: Canada
facility: Stratica Medical
state: Alberta
city: Barrie
country: Canada
facility: Ultranova Skincare
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research, Inc.
state: Ontario
Study officials:
References: