Phase 2
N=88
Efficacy and Safety Study of CD 2027 Spray in Subjects With Plaque-type Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT00763555 ↗Enrolled (actual)
88
Serious AEs
2.3%
Results posted
Aug 2022
Primary outcome: Primary: Percentage of Participants With Success Rate 1 (SR1) at Week 8 — 4.5; 0.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CD 2027 (Drug); Calcitriol Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Success Rate 1 (SR1) at Week 8 |
4.5; 0.0 | — |
| PRIMARY Percentage of Participants With Success Rate 2 (SR2) at Week 8 |
4.5; 0.0 | — |
| PRIMARY Change From Baseline in Dermatologic Sum Score (DSS) at Week 8 |
-1.2; -1.0 | — |
| PRIMARY Percentage of Participants With at Least 1-Grade Improvement From Baseline in Erythema, Scaling and Plaque Elevation |
38.6; 25.0; 40.9; 36.4; 34.1; 36.4 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
11; 9 | — |
| SECONDARY Percentage of Participants With a Local Tolerability Score Worse Than Baseline Score |
4.5; 7.0; 2.3; 0.0; 2.3; 4.7 | — |
| SECONDARY Change From Baseline in Calcitriol Plasma Levels |
-2.89; -8.82 | — |
| SECONDARY Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin |
-0.16; -0.08 | — |
| SECONDARY Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin-adjusted Calcium |
0.07; 0.03 | — |
| SECONDARY Change From Baseline in Serum Calcium Homeostasis Parameter: Calcium |
-0.09; -0.05 | — |
| SECONDARY Change From Baseline in Serum Calcium Homeostasis Parameter: Phosphorus |
-0.07; 0.02 | — |
| SECONDARY Change From Baseline in Serum Calcium Homeostasis Parameter: Parathyroid Hormone (PTH) Intact |
7.16; 5.15 | — |
| SECONDARY Change From Baseline in Blood Chemistry: Alkaline Phosphatase, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) |
0.58; -1.03; 1.42; -0.35; 0.72; -1.75 | — |
| SECONDARY Change From Baseline in Blood Chemistry: Bilirubin Direct, Bilirubin Total, Blood Urea Nitrogen (BUN) and Creatinine |
-0.02; -0.03; 0.01; 0.03; 0.65; 0.55 | — |
| SECONDARY Change From Baseline in Vital Sign Parameter: Heart Rate |
3.1; 1.4 | — |
| SECONDARY Change From Baseline in Vital Sign Parameter: Systolic Blood Pressure and Diastolic Blood Pressure |
0.7; -1.4; 0.2; -1.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00763555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.